Prostate Cancer cells

Clinical Trials

What Happens in Clinical Trials?
There are usually four phases of clinical trials. Each trial has a different purpose and helps scientists to answer important questions.

  • Phase I trials test the new treatment in a small group of people (usually 20-80) to evaluate its safety. Scientists want to know what happens to the drug in the human body, and what side effects may occur.
  • Phase II trials test whether the drug is effective by giving it to a larger group of people (around 100-300). This stage may last for several years. Scientists testing a new cancer drug will give one group of patients the experimental treatment, and the other 'control' group will be given the standard treatment for their condition.
  • Phase III trials test the drug or treatment in even larger groups of people to confirm its effectiveness, compare the new treatment with standard treatments and monitor its side effects. Around 25% of experimental treatments pass phase I,II and III tests. When a drug or treatment passes Phase III, the manufacturer can request approval to make and sell the product.
  • Phase IV trials are conducted once a drug is being used by patients. They gather additional information about the drug's risks, benefits and optimal use.

Would you like to participate in clinical trials?
We occasionally receive requests for help in recruiting men with prostate cancer for research studies. For more about taking part in a clinical trial and what is involved, visit our Information page on clinical trials.

Please read the information first and then contact the Lead Researchers, not Prostate Cancer UK, for further details if you think any study might be right for you.

Please note: As a matter of principle we are keen to encourage men to take part in clinical trials and research, as men may benefit from the extra attention that being in a trial confers. However, the presence of information about a study on this web site does not constitute a recommendation to take part in this particular study.

We have no connection with the research other than bringing it to your attention. It is up to you to decide whether it is the right thing for you and we suggest that you talk to your own medical team for advice. If you are a researcher, and want to advertise your project on this page, please contact web@prostatecanceruk.org.

Trials

Phase Ia/Ib dose escalation study evaluating the safety and tolerability of an androgen receptor antisense DNA therapeutic EZN4176 administered as a one hour IV weekly infusion in metastatic castration resistant prostate cancer (mCRPC) patients

Location of trial/study: Royal Marsden NHS Foundation Trust (Sutton branch, Surrey

Start date for recruitment: Recruiting

End Date for recruitment: Not planned

Number of men being recruited: 19

Aim of the trial/study:

To determine the safety and tolerability of EZN4176,an antisense DNA therapeutic, to establish the dose level which can be safely administered in subsequent studies

Criteria for inclusion/exclusion in trial:

  • Patients with prostate cancer which has spread outside the prostate in the bone or in the lymph nodes or in other organs
  • Patients with prostate cancer which became resistant to castration (LHRH analogues treatment/surgical castration)
  • Good general conditions and functional status
  • Satisfactory blood tests (bone marrow, liver and kidney function)
  • Previous histopathology diagnosis of prostate adenocarcinoma (generally obtained through a prostate biopsy)

What does the trial/study involve?

  • Visit to the PTTG (Prostate Targeted Therapy Group) at the Royal Marsden NHS Foundation Trust in Sutton.
  • Patient information sheets (PIS) on specific trials may be given to patients who meet the inclusion/exclusion criteria
  • If a patient expresses further interest in the trial, a consenting visit will be organized where questions regarding the trial will be answered and patients and a study doctor will sign the consent form.
  • Thereafter a screening visit will be planned to check that all the safety criteria are met as required for a specific trial.
  • Treatment starts generally 4-6 weeks after the first visit

More trial specific requirements:

  • Weekly visits for treatment consisting of one hour intravenous infusion of the study drug (ENZ4176)
  • PSA will be checked every 2 weeks.
  • Scans will be repeated every 12 weeks.

Want to know more?

Dr Diletta Bianchini
Specialty Doctor
Prostate Targeted Therapy Group
Royal Marsden Hospital
Downs Road, Sutton, Surrey SM2 5PT, UK
E-mail: Diletta.bianchini@icr.ac.uk
Tel. 020 8642 6011 #1393

Prof Johann S de Bono, MB ChB, FRCP, MSc, PhD
Professor in Experimental Cancer Medicine
Division of Clinical Studies, Institute of Cancer Research,
Drug Development Unit, Royal Marsden NHS Foundation Trust,
Downs Road, Sutton, Surrey SM2 5PT, UK
E-mail: johann.de-bono@icr.ac.uk
Tel: 44-20-8722-4302
Fax: 44-20-8642-7979

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Phase 1 / 2 Study to Evaluate Safety and Pharmacokinetics of a Novel Androgen Targeting Drug in Men with Advanced Prostate Cancer Who Have Not Yet Received Chemotherapy

Location of trial/study: Prostate Targeted Therapy Group at the Royal Marsden NHS Foundation Trust, Sutton.

Start date for recruitment: Currently recruiting.

End Date for recruitment: It is likely that study will continue at least through 2013.

Number of men being recruited: 14 men in Phase 1 (dose finding) plus 50 men in Phase 2 (expansion).

Aim of the trial/study:

To assess the safety of a novel oral androgen targeting drug in men with prostate cancer who have not yet received chemotherapy.

Key criteria for inclusion/exclusion in trial:

  • Biopsy proven adenocarcinoma of the prostate, with rising PSA.
  • Patients with prostate cancer which became resistant to castration (LHRH analogues treatment/surgical castration)
  • Good general conditions and functional status
  • Satisfactory blood tests (bone marrow, liver and kidney function)
  • Previous histopathological diagnosis of prostate adenocarcinoma (generally obtained through a prostate biopsy)
  • No prior treatment with chemotherapy or abiraterone

What does the trial/study involve?

  • Visit to the PTTG (Prostate Targeted Therapies Group) at the Royal Marsden NHS Foundation Trust in Sutton ) to discuss treatment options and suitable clinical trials
  • Patient information sheets (PIS) on specific trials may be given to patients who meet the inclusion/exclusion criteria
  • If a patient expresses further interest in the trial, a consenting visit will be organized where questions regarding the trial will be answered and patients and a study doctor will sign the consent form
  • Thereafter a screening visit will be planned to check that all the safety criteria are met as required for a specific trial. Treatment starts generally 4-6 weeks after the first visit and involves taking tablets each day
  • Generally, the trial requires at least weekly visits for safety checks and collection of blood samples for the first four weeks and monthly visits thereafter
  • PSA will be checked every 4 weeks
  • Scans will be repeated every 8 weeks.

Want to know more?

Dr Diletta Bianchini
Specialty Doctor
Prostate Targeted Therapy Group
Royal Marsden Hospital
Downs Road, Sutton, Surrey SM2 5PT, UK
E-mail: Diletta.bianchini@icr.ac.uk
Tel. 020 8642 6011 #1393

Prof Johann S de Bono, MB ChB, FRCP, MSc, PhD
Professor in Experimental Cancer Medicine
Division of Clinical Studies, Institute of Cancer Research,
Drug Development Unit, Royal Marsden NHS Foundation Trust,
Downs Road, Sutton, Surrey SM2 5PT, UK
E-mail: johann.de-bono@icr.ac.uk
Tel: 44-20-8722-4302
Fax: 44-20-8642-7979

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Phase 1 / 2 Study to evaluate safety and activity of the combination of two approved drugs cabazitaxel (second line chemotherapy) and abiraterone for men with advanced prostate cancer

Location of trial/study: Prostate Targeted Therapy Group at the Royal Marsden NHS Foundation Trust, Sutton.

Start date for recruitmen: Currently recruiting.

End Date for recruitmen: It is likely that study will continue at least through 2013.

Number of men being recruited: Approximately 38 patients.

Aim of the trial/stud:

To assess the safety and activity of cabazitaxel and abiraterone in men with advanced prostate cancer.

Key criteria for inclusion/exclusion in trial:

  • Biopsy proven adenocarcinoma of the prostate, with rising PSA or progression on scans after treatment with docetaxel (first-line chemotherapy).
  • Good general conditions and functional status
  • Satisfactory blood tests (bone marrow, liver and kidney function)
  • No prior treatment with mitoxantrone, cabazitaxel or abiraterone-like drugs.
  • No other important medical problems that might limit participation in the study.

What does the trial/study involve?

  • Visit to the Royal Marsden PTTG (Prostate Targeted Therapy Group)
  • Patient information sheets (PIS) on specific trials may be given to patients who meet the inclusion/exclusion criteria
  • If a patient expresses further interest in the trial, a consenting visit will be organized where questions regarding the trial will be answered and patients and a study doctor will sign the consent form, followed by safety checks and screening tests required for the trial.
  • Generally, the first 12 weeks on the trial require at least weekly visits for safety checks and collection of blood samples.

Want to know more?

Dr Diletta Bianchini
Specialty Doctor
Prostate Targeted Therapy Group
Royal Marsden Hospital
Downs Road, Sutton, Surrey SM2 5PT, UK
E-mail: Diletta.bianchini@icr.ac.uk
Tel. 020 8642 6011 #1393

Prof Johann S de Bono, MB ChB, FRCP, MSc, PhD
Professor in Experimental Cancer Medicine
Division of Clinical Studies, Institute of Cancer Research,
Drug Development Unit, Royal Marsden NHS Foundation Trust,
Downs Road, Sutton, Surrey SM2 5PT, UK
E-mail: johann.de-bono@icr.ac.uk
Tel: 44-20-8722-4302
Fax: 44-20-8642-7979

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Phase I dose escalation study evaluating the safety and tolerability of a AZD3514, a selective androgen receptor degrading drug in patients with advanced castration resistant prostate cancer

Location of trial/study: Royal Marsden NHS Foundation Trust (Sutton branch, Surrey)

Start date for recruitment: Recruiting

End Date for recruitment: Not known

Number of men being recruited: 50

Aim of the trial/study:

To determine the safety and tolerability of AZD3514, a pill that results in the degradation of the androgen receptor that drives prostate cancer growth. In a defined group of patients (cohort), AZD3514 will be added to patients who are on Abiraterone (an approved oral hormonal agent) and have initially responded but are now progressing by PSA.

Criteria for inclusion/exclusion in trial:

  • Patients with prostate cancer which has spread outside the prostate in the bone or in the lymph nodes or in other organs
  • Patients with prostate cancer which became resistant to castration (LHRH analogues treatment/surgical castration)
  • Good general conditions and functional status
  • Satisfactory blood tests (bone marrow, liver and kidney function)
  • Previous histopathological diagnosis of prostate adenocarcinoma (generally obtained through a prostate biopsy)

What does the trial/study involve?

  • Visit to the Royal Marsden NHS Foundation Trust
  • Patient information sheets (PIS) on specific trials may be given to patients who meet the inclusion/exclusion criteria
  • If a patient expresses further interest in the trial, a consenting visit will be organized where questions regarding the trial will be answered and patients and a study doctor will sign the consent form.
  • Thereafter a screening visit will be planned to check that all the safety criteria are met as required for a specific trial.
  • Treatment starts generally 4-6 weeks after the first visit

More trial specific requirements:

  • AZD3514 is a trial that is run in the Drug Development Unit of the Royal Marsden NHS Foundation Trust.
  • Generally, the first four weeks on the trial require at least weekly visits for safety check and collection of blood samples. This may also include overnight stays in the hospital.
  • PSA will be checked every 2-4 weeks.
  • Scans will be repeated every 6-12 weeks.

Want to know more?

Dr Diletta Bianchini
Specialty Doctor
Prostate Targeted Therapy Group
Royal Marsden Hospital
Downs Road, Sutton, Surrey SM2 5PT, UK
E-mail: Diletta.bianchini@icr.ac.uk
Tel. 020 8642 6011 #1393

Prof Johann S de Bono, MB ChB, FRCP, MSc, PhD
Professor in Experimental Cancer Medicine
Division of Clinical Studies, Institute of Cancer Research,
Drug Development Unit, Royal Marsden NHS Foundation Trust,
Downs Road, Sutton, Surrey SM2 5PT, UK
E-mail: johann.de-bono@icr.ac.uk
Tel: 44-20-8722-4302
Fax: 44-20-8642-7979

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Phase 3 Study to evaluate the efficacy of  docetaxel first-line chemotherapy plus/minus a novel antisense therapy targeting the antiapoptotic protein Clusterin for men with advanced prostate cancer

Location of trial/study: Prostate Targeted Therapy Group at the Royal Marsden NHS Foundation Trust, Sutton.

Start date for recruitment: Currently recruiting.

End Date for recruitment: It is likely that study will continue at least through the autumn of 2012.

Number of men being recruited: Approximately 600 patients.

Aim of the trial/study:

Phase 3 Study to evaluate the efficacy of docetaxel first-line chemotherapy plus/minus a novel antisense therapy targeting an antiapoptotic protein Clusterin for men with advanced prostate cancer

Key criteria for inclusion/exclusion in trial:

  • Biopsy proven adenocarcinoma of the prostate, with rising PSA or progression on scans
  • Patients with prostate cancer which has spread outside the prostate in the bone or in the lymph nodes or in other organs
  • Patients with prostate cancer which became resistant to castration (LHRH analogues treatment/surgical castration)
  • Good general conditions and functional status
  • Satisfactory blood tests (bone marrow, liver and kidney function)
  • Previous histopathological diagnosis of prostate adenocarcinoma (generally obtained through a prostate biopsy)
  • No prior treatment with chemotherapy

What does the trial/study involve?

  • Visit to the PTTG (Prostate Targeted Therapy Group) at the Royal Marsden NHS Foundation Trust
  • Patient information sheets (PIS) on specific trials may be given to patients who meet the inclusion/exclusion criteria
  • If a patient expresses further interest in the trial, a consenting visit will be organized where questions regarding the trial will be answered and patients and a study doctor will sign the consent form, followed by safety checks and screening tests required for the trial.
  • If a patient is considered eligible for the trial at the screening visit he will be randomized between arm A (the combination of the standard docetaxel chemotherapy with Clusterin) and arm B (the standard docetaxel chemotherapy)
  • Generally, chemotherapy is given every 3 weeks. The clusterin treatment is administered once weekly.

Want to know more?

Dr Diletta Bianchini
Specialty Doctor
Prostate Targeted Therapy Group
Royal Marsden Hospital
Downs Road, Sutton, Surrey SM2 5PT, UK
E-mail: Diletta.bianchini@icr.ac.uk
Tel. 020 8642 6011 #1393

Prof Johann S de Bono, MB ChB, FRCP, MSc, PhD
Professor in Experimental Cancer Medicine
Division of Clinical Studies, Institute of Cancer Research,
Drug Development Unit, Royal Marsden NHS Foundation Trust,
Downs Road, Sutton, Surrey SM2 5PT, UK
E-mail: johann.de-bono@icr.ac.uk
Tel: 44-20-8722-4302
Fax: 44-20-8642-7979

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Royal Marsden study into family histories of prostate cancer

A research study at the Royal Marsden Hospital is recruiting 10,000 men who have a family history of prostate cancer. The researchers are trying to find out more about what causes prostate cancer and how a family history of the disease affects a man's risk of being diagnosed. They would like to hear from men who have been diagnosed with prostate cancer and:

  • Were diagnosed at age 60 or under, or
  • Have a close family member (brother, father, son, nephew, cousin, grandfather) who has been diagnosed, and at least one of you was diagnosed at age 65 or under, or
  • Have two or more family members who have been diagnosed at any age.

The study will involve answering a questionnaire about your family's health and giving a blood sample. To find out more, contact Michelle Guy on 020 8661 3507.

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Clinical trial recruits men with BRCA1 or BRCA2 gene

A study is taking place across 21 UK cancer centres to find a way of testing men with either the BRCA1 or BRCA2 gene for prostate cancer. The IMPACT study is looking for men aged between 40 and 69 years, who have already been tested for the gene. If you have been tested for BRCA1 or BRCA2 and would like to take part in the trial, call Liz Bancroft, Research Nurse for the trial, on 020 7808 2136 for more details. She would like to hear from men who have tested positive or negative for the gene, but you must have already been tested.

If you have not had any genetic tests, and are concerned about your family history of prostate or breast cancer, ask your GP for advice on getting help from a genetics centre. Or call our confidential Helpline on telephone 0800 074 8383 (Mon-Fri 10am-4pm, Wed 7pm-9pm).

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RADICALS: Radiotherapy and Androgen Deprivation In Combination After Local Surgery. A randomised controlled trial in prostate cancer

Location of trial: Aberdeen, Ashford, Aylesbury, Ayr, Bangor, Barnstaple, Basingstoke, Bath, Belfast, Birmingham, Blackburn, Bournemouth, Bradford, Brighton, Bristol, Burnley, Cambridge, Canterbury, Cardiff, Carlisle, Chelmsford, Cheltenham, Chester, Chesterfield, Colchester, Cottingham, Coventry, Crewe, Croydon, Derby, Doncaster, Dorchester, Edinburgh, Edmonton, Exeter, Glasgow, Gloucester, Guildford, Harlow, Hereford, High Wycombe, Inverness, Ipswich, Keighley, Larbert, Leeds, Lincoln, Liverpool, London, Maidstone, Manchester, Middlesbrough, Newcastle-upon-Tyne, Newport, Northampton, Northwood, Nottingham, Oldham, Oxford, Peterborough, Plymouth, Poole, Portsmouth, Preston, Reading, Redditch, Rhyl, Romford, Rotherham, Salford, Salisbury, Scunthorpe, Sheffield, Shrewsbury, Slough, Southampton, Southend, Southport, Stockport, Stoke-on-Trent, Sutton, Sutton Coldfield, Swindon, Taunton, Torquay, Uxbridge, Wakefield, Weston Super Mare, Wirral, Wishaw, Worcester, Worthing, Wrexham and York(Also in Canada, Denmark and Ireland).

Start date for recruitment: November 2007
End date for recruitment: May 2013 (estimated)
Number of men being recruited: 3000

Aim of the trial

The study will answer two important questions for men who have had surgery for prostate cancer:

  • When should radiotherapy be given after surgery?
  • Should hormone treatment be given at the same time as radiotherapy after surgery?

In breast cancer, surgery is followed by radiotherapy and hormone treatment, because the combination is better than surgery alone. In prostate cancer, surgery alone is a standard treatment, and we are not sure how best to use radiotherapy and hormone treatment after surgery.

RADICALS is taking place all around the UK. The trial may be suitable at some point for most men who have a radical prostatectomy.

Criteria for inclusion in trial*

You can enter this trial if you:

1. have prostate cancer
2. are a patient having undergone radical prostatectomy to remove the prostate

Criteria for exclusion in trial*

You cannot enter this trial if you:

1. if your prostate cancer has spread to another part of the body
2. are a patient having undergone hormone therapy in the last six months
3. are a patient having undergone radiotherapy to the lower abdomen (pelvic area)

* There are some other inclusions and exclusions for the separate comparisons

What does the trial involve?

There are two parts to the study, the Radiotherapy Timing Comparison and the Hormone Duration Comparison. What happens in each comparison is explained below.

Radiotherapy Timing Comparison

This is for men who have recently had surgery for prostate cancer. In this part of the study, patients will be randomly allocated to one of these two treatment groups:

  • radiotherapy now (Group 1)
  • monitoring with radiotherapy only if the PSA level starts to rise (Group 2).

Hormone Duration Comparison

This is for men who are due to have radiotherapy after surgery. Patients will be randomly allocated to one of these three treatments:

  • either radiotherapy alone
  • or radiotherapy plus hormone therapy for 6 months (short-term)
  • or radiotherapy plus hormone therapy for 2 years (long-term)

For further information, contact your local hospital doctor.

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A trial looking at high pressure oxygen (hyperbaric oxygen) treatment for people who have long term side effects following radiotherapy treatment for pelvic cancer

(This includes prostate cancer, rectal cancer, testicular cancer, bladder cancer, cervical cancer, womb cancer and ovarian cancer.)

Location of trial: The trial is looking for volunteers from anywhere in the UK, but will require the participants to be willing to travel to The Royal Marsden Hospital in London for baseline assessments and at 2 weeks and 12 months after their hyperbaric sessions. All volunteers will also attend one of the specialist hyperbaric medicine centres taking part in this study to have hyperbaric oxygen therapy (HBO).
Start date for recruitment: 1 April 2009
End date for recruitment: 1 April 2011
Number of men being recruited: 75 in total

Aim of the trial

Some patients who have radiotherapy to treat their pelvic cancer have long term side effects which can significantly affect their quality of life. Radiotherapy can cause 'hardening' of the tissue (scar tissue) in the treatment area. This can lead to bowel problems such as diarrhoea, rectal bleeding, wind and bowel pain. In this trial volunteers will breathe either 100% oxygen under pressure (HBO treatment) or 21% oxygen (air) under pressure (the control group). The 2 groups will be compared to find out if HBO relieves bowel symptoms caused by radiotherapy.

Criteria for inclusion in trial

You can enter this trial if you:

1. Had pelvic cancer in the past which has not spread outside the pelvis
2. Had radiotherapy at least 12 months ago
3. Have no signs of cancer now
4. Have bowel problems caused by your radiotherapy
5. Are well enough for hyperbaric oxygen therapy
6. Are over 18 years old

Criteria for exclusion in trial

You cannot enter this trial if you:

1. Have had surgery for rectal cancer
2. Have had hyperbaric oxygen therapy before
3. Have had a chemotherapy drug called bleomycin before
4. Have a fear of small spaces (claustrophobia)
5. Have epilepsy
6. Have serious breathing problems or a medical condition that affects your lungs
7. Have had an operation on your ears in the past, except to drain fluid from the ear (grommets), or you have problems with the pressure in your ears
8. Are not able to have an MRI scan (have metal clips in your body or a pacemaker for example)

What does the trial involve?

Before you can start the study, you will see a bowel specialist. They will ask you about the long term side effects of radiotherapy and how it affects your daily life. They may suggest other ways to improve your symptoms, which you must try before taking part in this trial. If this treatment or advice helps, then you will no longer be able to take part.

If you are able to take part in this study, you will see the research team in London for some tests to check what effect the radiotherapy has had on your bowel. You will have a sigmoidoscopy - a sample of tissue (biopsy) taken from your rectum.

You also have these tests 2 weeks after treatment finishes and 12 months after you start treatment. The research team will use these tissue samples to learn more about the long term side effects of radiotherapy and how HBO treatment works.

Hyperbaric Medicine Centres

All volunteers attend one of the specialist hyperbaric medicine centres taking part in this study to have hyperbaric oxygen therapy (HBO), 5 days a week (Monday to Friday), for 8 weeks. Each treatment takes about an hour and a half.

For further information, contact

Miss Sue Martin
Email:  Sue.Martin@icr.ac.uk
Telephone: 020 8661 3273

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Randomised controlled trial of Laparoscopic, OPEn and Robot Assisted prostatectomy as treatment for organ-confined prostate cancer

Location of trial/study

London and surrounding area

Start date for recruitment

March 2010

End Date for recruitment

August 2011

Number of men being recruited

The aim is to recruit 75 patients in a 12 month period

Aim of the trial study

Radical prostatectomy is a common, major surgical operation for the removal of a cancerous prostate gland through the abdomen (tummy area) and has traditionally been performed as an open operation. More recently keyhole techniques have been developed as an alternative means to perform this operation. The keyhole technique may be performed with the assistance of robotic technology. Currently, choice of whether to perform the operation as a traditional open operation or as a keyhole operation is determined by a combination of local availability of necessary equipment and the surgeon's personal bias and experience, rather than by results published in respected medical journals.

This study will determine whether it is possible to recruit sufficient numbers of patients (a pilot study) to carry out a clinical trial comparing open, laparoscopic and robot-assisted radical prostatectomy.

If patient recruitment to this pilot study is successful, a larger national clinical trial will be carried out to determine which of the three surgical techniques gives the best outcomes and quality of life for patients with prostate cancer.

The study is being funded by Cancer Research UK, trial number CRUK/09/008 and run by the Institute of Cancer Research and Imperial College London.

Criteria for inclusion/exclusion in trial

Patients can participate in this trial if they have opted to have an operation (radical prostatectomy) as treatment for their prostate cancer. Men, with organ-confined prostate cancer, as determined on clinical examination and/or imaging and PSA and prostate biopsy results, who are medically fit to undergo surgery, are generally eligible for inclusion. Patients should not have received previous pelvic radiotherapy or undergone surgery to remove their rectum. Specific inclusion/exclusion criteria, based on PSA and prostate biopsy results can be discussed in more detail if you decide that you want to see a surgeon involved in the trial.

What does the trial/study involve?

Patients are allocated to one of three groups of patients. It is important that the three groups of patients are as similar to each other as possible. This is because we need to ensure that if one group has a better outcome than the other groups it is due to the surgical procedure used and not because the patients in the groups are different from each other in some way. The only way to make sure that the groups are as similar as possible is by allocating patients to a group at random. There will therefore be a 1 in 3 chance of having a particular surgical technique.

Patients are asked to sign a consent form accepting involvement in the trial. This is in addition to the standard consent form that needs to be completed before patients can undergo surgery for their prostate cancer.

Patients who take part in the trial will be treated in exactly the same way as patients who are not in the trial but having the same type of operation. Risks and side effects of the operation are therefore no different in and out of the trial setting and will be explained as part of the informed consent process leading up to their surgery.

Want more information?

Contact name and address for interested participants:

Mr Erik Mayer

Clinical Lecturer in Surgery

Email: e.mayer@imperial.ac.uk

Tel: 020 7886 1006

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A trial of devices for management of urinary incontinence following prostate cancer surgery and other treatments for prostate cancer

Location of trial: The trial is looking for volunteers from the southern counties of England including Surrey, Hampshire, South Wiltshire, Dorset and Sussex. The Isle of Wight and parts of Kent and Middlesex may be included dependent on location. This is because our clinical nurse will be visiting the participants during the study and there is a limit to the distance she can travel from her base in Southampton.

The trial is being undertaken by the Continence & Skin Health Group at the University of Southampton

(School of Health Sciences, Level A, (MP11) South Academic Block, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD).

Aim of the trial

If you have developed urinary incontinence after having a prostatectomy or other treatments for prostate cancer, you may well be using absorbent incontinence pads. You may be unaware that there are alternative products designed specifically for men which are available to you. We are a team of researchers (nurses, doctors and scientists) doing a research project to find out which of the available alternative devices men prefer and why. This information will help doctors and nurses provide a more suitable range of products to men with this distressing symptom.

During the study you will be able to try out a range of products which we will give you. Our clinical nurse will visit you at home - there is no need for you to go to the hospital.

If you:

  • Are male over 18 years old
  • Have had a prostatectomy or other treatment for prostate cancer
  • Have had urinary incontinence for at least 12 months since
  • And would like to know more about this study

please contact Margaret Macaulay, Research Nurse at the:

Continence & Skin Technology Group, University College London, 3rd Floor Clerkenwell Building, Archway Campus, Highgate Hill, London N19 5LW.

Tel: 020 7288 3178 Email: m.macaulay@ucl.ac.uk

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PROMIS Trial

Location of trial/study - University College London and Basingstoke Hospitals for pilot phase (March 2012 - approx. March 2013) . Six centres for main phase UCL, Basingstoke and 4 pre-selected centres.

Start date for recruitment - March 2012.

End date for recruitment - December 2015 (estimated).

Number of men being recruited - 50 for the pilot phase, 714 for the whole trial.

What does the trial/study involve?

Four trial visits, registration, multi-parametric magnetic resonance imaging (MP-MRI), followed by a combined procedure of template prostate mapping (TPM) and Transrectal ultrasound (TRUS) guided biopsy and end of study visit.

Aim of the trial/study

PROMIS will help to determine whether a new diagnostic pathway can be proposed for men suspected of harbouring prostate cancer. Currently, up to 80,000 UK men have TRUS biopsies annually, with around 35,000 diagnosed with prostate cancer (PCa). TRUS biopsy has a number of disadvantages: missing clinically important PCa, overdiagnosis of clinically insignificant PCa, unable to accurately risk stratify men, side-effects particularly sepsis related to multi-resistant bacteria.

This study will answer three important questions:

  • What is the ability of MP-MRI to identify men who can safely avoid unnecessary biopsy?
  • What is the ability of the MP-MRI based pathway to improve the rate of detection of clinically significant prostate cancer as compared to transrectal ultrasound (TRUS) guided biopsy?
  • What is the estimated cost-effectiveness of an MP-MRI based diagnostic pathway?

The potential clinical impact of PROMIS could be a new diagnostic pathway, such that fewer men need to be biopsied, fewer biopsies in the men that do need them and fewer men being diagnosed with PCa.

Criteria for inclusion in trial

You can enter this trial if you:

  • Are aged 18 years or over, are at risk of prostate cancer and have been advised to have a prostate biopsy.
  • Have a serum PSA value of less than or equal 15ng/ml in the last 3 months.
  • Have suspected less than or equal T2 on rectal examination.
  • Are fit for general/spinal anaesthesia and all study procedures.

Criteria for exclusion in trial

You cannot enter this trial if you:

  • Have been treated using 5-alpha reductase inhibitors at time of registration or during the prior 6 months
  • Have a previous history of prostate biopsy, prostate surgery or treatment for prostate cancer.
  • Have urinary tract infection or history of acute prostatitis within the last 3 months.
  • Have a contraindication to MRI or any other medical condition precluding study procedures.
  • Previous history of hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work.

Contact name and address for interested participants?

Cybil Kwakye
PROMIS Trial Manager
MRC Clinical Trials Unit
Aviation House
125 Kingsway
London WC2B 6NH

Website: http://www.ctu.mrc.ac.uk/promis.aspx

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A Multi-Centre Trial Evaluating Focal Therapy using High Intensity Focused Ultrasound for Localised Prostate Cancer

Location of trial/study: University College Hospital London, The Royal Marsden NHS Foundation Trust, Imperial College Hospital NHS Trust, Basingstoke and North Hampshire Hospital NHS Foundation Trust, Radcliffe Hospital Oxford NHS Trust, University Hospitals Bristol NHS Foundation Trust.

Start date for recruitment: 29thJune 2011

End Date for recruitment: 1st May 2013

Number of men being recruited: 140

Aim of the trial study: To evaluate medium term cancer control, genitourinary, rectal and overall health-related quality of life outcomes, and to model potential cost effectiveness of focal therapy for localised prostate cancer using HIFU.

Criteria for inclusion/exclusion in trial:

You can enter this trial if you have prostate cancer and you have had biopsies that show any of the following:

  • All of the cancer is on one side of the prostate
  • You have cancer on both sides of the prostate but on one side the cancer is no more than 3mm across and has a Gleason score of no more than 3+3
  • You have cancer on both sides of the prostate that measures 3mm or less and has a Gleason score of 3+3 ('clinically unimportant cancer'), but one side of the prostate has more cancer than the other

You must also have the following:

  • Cancer that is still contained inside the prostate gland
  • The maximum Gleason score of cancer is no more than Gleason 4+3
  • A PSA reading of 15 or less
  • A life expectancy of at least 10 years
  • The ability to understand information about the trial in English

You cannot enter this trial if you:

  • Have had radiotherapy
  • Have had hormone therapy for prostate cancer in the last 12 months
  • Have had a scan that shows your cancer spread to your lymph nodes or other parts of your body
  • Would not be able to have an ultrasound probe put into your back passage to scan your prostate for any reason
  • Are allergic to latex
  • Have had HIFU, cryosurgery, heat treatment or microwave treatment in the past to the prostate
  • Have had a type of surgery called a transurethral resection of prostate (TURP) in the last 6 months
  • Would not be fit enough to have a general anaesthetic
  • Are not able to have an MRI scan for any reason, for example you have some metal in your body, or a pacemaker, or cannot cope with being in small spaces
  • Have a build up of a significant amount of calcium or cysts in your prostate, which would affect HIFU treatment - an ultrasound scan will show this
  • Your kidneys do not work well enough to get rid of the dye used for the MRI scan

What does the trial/study involve?

Before you join the trial you will see the doctor and have some tests. These tests include

  • A PSA blood test
  • A physical examination

If you have not already had them, you will also have:

  • An MRI scan
  • A prostate biopsy taken through the skin between your testicles and back passage (a transperineal template biopsy) - you will have a general anaesthetic for this.

One or 2 weeks after HIFU, you have your catheter removed and another MRI scan.

You will see the doctor, have a blood test and fill out a questionnaire after 6 weeks, and then 3, 6, 9, 12, 18, 24, 30 and 36 months after HIFU.

If your trial hospital is happy with this, some of these visits can be replaced with telephone conversations with the trial team and blood tests with your GP. In this case, you would fill out the questionnaires at home and return them to the team in pre paid envelopes.

You will also have blood tests taken at your GP surgery at 15, 21, 27 and 33 months after HIFU.

At the 12 month appointment, you will also have another MRI scan and more biopsies under local anaesthetic, using an ultrasound scan of your prostate through the back passage. The biopsies will take about 20 minutes, and you should not need to stay in hospital. You will see the doctor for these results once available.

At the 36 month appointment, you will have another MRI scan, and another template biopsy under general anaesthetic.

If your centre is carrying out HistoScanning, you have this additional scan:

  • Just before your template biopsies, or just before HIFU
  • At the 12 month visit, just before your biopsies
  • At 36 months, just before your last biopsies


You then see the trial team for the last time 38 months after your treatment. They will discuss the results of your biopsies and MRI scan.

If you agree to the extra blood tests, you will have these at your first visit (before treatment), and again at 12 months and 36 months after HIFU treatment.

Want to know more?

Contact: Helena Stone INDEX Trial Nurse

Address:
 CCTU, University College Hospital London, 3rd Floor West, 250 Euston Road, London, NW1 2PG

Email:helena.stone@uclh.nhs.uk
Phone
 020 3447 7364/07527961138

Alternative Contact: Louise Dickinson INDEX Trial Co-ordinator and Academic SpR in Urology

Address: University College Hospital London, Urology Department, 250 Euston Road, London, Nw1 2PG

Email:louise.dickinson@uclh.nhs.uk
Phone
 020 3447 9194 (Via Professor Emberton's PA)

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PICTURE: Prostate Imaging (multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound guided biopsy for significant prostate cancer Risk Evaluation

Location of trial/study:

University College Hospital London Trust, Department of Urology, 250 Euston Road

London NW1 2PG

Start date for recruitment: January 2012

End Date for recruitment: July 2013 (estimated)

Number of men being recruited: 126

Aim of the trial

The purpose of this study is to look at the role of imaging techniques - multi parametric Magnetic Resonance Imaging (mp-MRI) and Prostate HistoScanning™ in detecting and more accurately assessing the burden, grade and stage of prostate cancer, in men who have already had a transrectal biopsy.

At the moment prostate cancer is one of the only cancers where no imaging technique is routinely used in diagnosing the cancer. TRUS biopsy uses ultrasound to guide the needle into the prostate but it is not very good at 'seeing' areas of cancer, so samples are taken from areas where prostate cancer is commonly found.

If an imaging test can be found that can reliably detect prostate cancer and help us locate it within the prostate, this could be very useful. It could allow men to have a biopsy targeted at the abnormal area, in a similar way to the way that breast cancers and many other cancers are targeted. This could give a more accurate diagnosis of how much cancer there is in the prostate and how aggressive it is. Also, for those men who don't have cancer, an imaging test may allow them to avoid a biopsy altogether.

If the imaging tests in the study show an area that is suspicious for cancer in the prostate, we will obtain a number of biopsies directed at these areas at the time of the template prostate mapping biopsies. We will do this to assess if the imaging tests can help us target the cancer and obtain more accurate samples. By analysing the biopsy results and the imaging results together, in a large group of men, we will be able to tell if the imaging results are able to answer the question of whether or not a man has prostate cancer, how much cancer he has, and where it is.

Criteria for inclusion/exclusion in trial

Inclusion criteria

  • Men who have undergone prior trans-rectal biopsies.
  • Men undergoing further evaluation of their prostate and who are suitable for characterisation using Transperineal template prostate mapping biopsy.

Exclusion criteria

  • Previous history of prostate cancer treatment
  • Men unable to have MRI scan, or in whom artefact would reduce quality of MRI
  • Men unable to have general or regional anaesthesia
  • Men unable to give informed consent

Withdrawal Criteria

  • Men who are unfit or choose to not undergo Prostate Mapping biopsies after undergoing either or both index test

What does the trial/study involve?

Four trial visits, Consent and screen and Prostate HistoScanning, MP-MRI, Template prostate mapping biopsy (TPM) and a final study completion phone call.

Prostate HistoScanning involves taking detailed ultrasound (sound-waves) images of the prostate. Multi-Parametric MRI (mp-MRI) uses magnetic pulses to take detailed images of the prostate gland. Both of these imaging tests will be compared to a very detailed biopsy procedure called Transperineal Template Prostate Mapping Biopsy (TPM), this procedure is performed under a short general anaesthetic as a day case operation. This involves taking biopsy samples through the skin between the scrotum and back passage, at 5mm intervals. As well as giving a Gleason score and an assessment of the amount of cancer in the prostate, it can also tell us where in the prostate the cancer is.

Want to know more?

Contact:

Miss Lucy Simmons MBBS, MRCS (Eng)
PICTURE Trial Co-Ordinator
University College Hospital London Trust
Department of Urology
250 Euston Road
London
NW1 2PG

Tel: 020 7679 9092 (Clinical Research fellows office) or 020 3447 9194 (via Professor Emberton's secretary)
Fax: 020 3447 9303

Email: Lucy.simmons@uclh.nhs.uk

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Managing hot sweats in men who are having prostate cancer treatment

Location of trial/study Guy's Hospital, London Bridge, London SW11 9RT

Start date for recruitment 20th April 2012

End Date for recruitment 20th April 2013

Number of men being recruited 80

Aim of the trial study To find out if a non-medical treatment (self-help booklet and relaxation/paced breathing) will reduce the impact of hot sweats

Criteria for inclusion/exclusion

1) You have more than 10 bothersome hot flushes a week
2) You are not currently having chemotherapy

What does the trial/study involve?

We make an initial appointment during which we ask you questions about your symptoms among other things, and we also give you a small hot sweats monitor to wear on your chest for a couple of days. We then allocate you to either the treatment group or to the control group. If you enter the control group, we will still offer you the treatment but only after the initial trial is finished (6 months approximately). If you enter the treatment group, we give you a recently developed booklet with advice and exercises that have been found in our previous research to reduce the impact of hot sweats and improve mood and sleep. We then see you 5-6 weeks later for repeat assessments. We also conduct follow-up assessments after 6 months. So in total, you will need to come in to Guy's Hospital 3-4 times over this period.

Are you interested in taking part or want to know more?

Then please contact: Dr. Evi Stefanopoulou e.stefanopoulou@iop.kcl.ac.uk 020 7188 9558 or Dr. Omar Yousaf omar.yousaf@kcl.ac.uk 020 7188 9559
who will be happy to discuss the study and provide more information about the study.

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CROP (CRyOtherapy in Prostate cancer) A Randomised Controlled Trial of Deferred Androgen Deprivation Therapy ± upfront Cryotherapy in men with localised Radiation Recurrent Prostate Cancer (RRPC) to Evaluate Efficacy and Tolerability

Location of trial/study At present the trial is open to recruitment at the Wirral Hospital in Liverpool and the Beatson WoSCC. Other sites in set up include Norfolk and Norwich, Sunderland and King's College. There are several other UK sites that have shown an interest in the study but are in the early stages of site set up.

Start date for recruitment The first patient was recruited in August 2011

End Date for recruitment Estimated to be February 2016

Number of men being recruited 540

Aim of the trial study

There is significant uncertainty regarding the most effective treatment of patients with recurrent prostate cancer following previous radiotherapy. In order to formally assess if cryotherapy or androgen deprivation therapy is the most effective form of treatment for this patient group the CROP trial has been developed. The aims of the study are below:

Primary aim - To determine the effectiveness of salvage prostate cryotherapy in combination with deferred androgen deprivation therapy (ADT) in patients with radiation recurrent prostate cancer (RRPC)

Secondary aims - To evaluate the safety and tolerability of prostate cryotherapy in patients with RRPC

To determine the side effect profile of salvage cryotherapy and its impact on the quality of life of patients.

To determine the likely costs to the NHS if cryotherapy is adopted widely for RRPC

Criteria for inclusion/exclusion

Inclusion criteria

  1. Histologically confirmed relapsed prostate cancer following previous treatment with radiation therapy (either external beam or brachytherapy) for either organ confined or non-metastatic locally advanced prostate cancer, namely T1-3aN0M0 disease
  2. Life expectancy of at least 5 years
  3. Clinical/radiological T1c-T3a
  4. PSA level ≤ 20 ng/ml
  5. Aged 18 years or over
  6. ECOG PS = 0 or 1 or 2
  7. Ability to provide informed consent
  8. Adequate haematological function as defined by Hb ≥ 100g/L; platelets ≥ 100 x 109/L; neutrophils ≥1.5 x109/L
  9. Adequate biochemical function as defined by bilirubin ≤ 1.5 ULN; ALT, AST ≤ 2.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN and adequate renal function defined as EITHER serum creatinine ≤ 1.5 x ULN OR calculated/measured creatinine clearance ≥ 60mls/min (as defined by Cockcroft and Gault formula)

Exclusion criteria

  1. Lymph node >10mm short axis on MRI abdomen and pelvis
  2. Previous transurethral resection of prostate gland with evidence of a significant defect (>10mm in width) on transrectal ultrasound scan
  3. Significant lower urinary tract symptoms, including bladder outflow obstructive symptoms
  4. History of abdomino-perineal resection of rectum.
  5. Known coagulation disorder
  6. Complex perianal fistula
  7. Previous combined external beam radiotherapy and brachytherapy to the prostate
  8. Significant symptoms/toxicity related to the rectum following radiotherapy (NCI CTCAE grade 3 or above)
  9. Previous androgen deprivation therapy as second line therapy for radiation recurrent prostate cancer
  10. Prior cryotherapy to the prostate
  11. 11. Any evidence of severe or uncontrolled systemic conditions (e.g. severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol

Other prior malignancy with estimated ≥30% chance of relapse within 5 years

What does the trial/study involve?

Patients are either randomised to receive deferred ADT alone (Arm A) or upfront prostate cyrotherapy and deferred ADT (Arm B).

ADT reduces the amount of testosterone in the body which can prevent further cancer growth or shrink the tumour. This can be given in the form of injections or tablets and this will be decided between the patient and their Doctor.

Prostate Cyrotherapy aims to eradicate prostate cancer by freezing the cancer cells under a general anaesthetic. A surgeon inserts needles into the prostate gland and these are cooled by channelling gas through the needles at high pressure. The procedure lasts approximately 2 hours and involves a 2 night stay in hospital.

Study Assessments

Patients must have recent (within 90 days of randomisation) MRI and bone scan performed prior to study entry as well as a physical exam, PSA measurement, Serum Biochemistry, Full Blood Count, and Urine Culture.

For the first year of the trial 3 monthly PSA measurements will be taken as well as quality of life questionnaires filled in, these will be posted to the patient's home. Patients will also be assessed for any adverse events at hospital appointments or over the telephone.

At 6 months after randomisation patients on the cyrotherapy arm will have a prostate biopsy performed.

Annually patients will have bone scan and MRI as well as fill in quality of life questionnaires and be assessed for any adverse effects.

Are you interested in taking part or want to know more?

Clinical Trial Coordinator
Jennifer Petrie
Cancer Research UK Clinical Trials Unit
Level 0
Beatson West of Scotland Cancer Centre
1053 Great Western Road
GLASGOW G12 0YN

Tel: 0141 301 7241
Fax: 0141 301 7228
Email:jennifer.petrie@glasgow.ac.uk

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