A study looking at giving men with prostate cancer a DVD/video on treatment for prostate cancer and the possibility of a study comparing 2 different treatments for prostate cancer (SABRE1)

Please note this trial is no longer recruiting patients.

This study is looking at giving men with prostate cancer a DVD/video to help them decide which treatment to have. And to find out if a study comparing radical prostatectomy with brachytherapy to the prostate can be done.

When men are diagnosed with prostate cancer their doctor will discuss treatments that are available to them. They are also given written information to take home on prostate cancer and its treatment, to help them decide which treatment is best for them.

Half the men in this study are given written material on prostate cancer and treatment. The other half are given a DVD/video on prostate cancer and its treatment, as well as the written material. The researchers want to see if this helps them in making their treatment decision.

Two possible treatments for prostate cancer are surgery (radical prostatectomy) and brachytherapy. Very few studies have been done comparing their benefits. This study also wants to find out if it is practical to set up another study to compare these 2 treatments.

This study aims to find out

If the DVD/video helps men to choose which treatment to have
If a study comparing radical prostatectomy and brachytherapy to the prostate can be done

Recruitment

Start 08/06/2009

End 06/05/2011

Phase

Pilot

Who can enter

For part 1 you can enter this trial if

You are due to have a prostate biopsy or have had one in the last 6 weeks
You have cancer that is completely inside your prostate gland (stage T1, T2)
Your PSA is less than 15
You are well enough (performance status 0, 1)

For part 2 you can enter this trial if you

Have prostate cancer that is completely inside your prostate gland (stage T1, T2)
Have a Gleason score of 6, or less, with a PSA of less than 15 or Gleason score 3+4 with a PSA less than 10 (your doctor can give you this information)
Are able to have surgery to remove your prostate (radical prostatectomy) OR are able to have brachytherapy (your doctor can advise you about this)
Have satisfactory blood results
Are well enough to have the treatments in this study (performance status 0, 1)
Are willing to use reliable contraception during brachytherapy and for 2 months after (your doctor can advise you about this)

You cannot enter this trial if

Your Gleason score is above 7
You are unable to have a radical prostatectomy or brachytherapy (your doctor can advise you about this)
You have had radiotherapy to the pelvis before
You have had surgery to remove part of your prostate (transurethral resection of the prostate (TURP))
You have had surgery to remove your rectum
You have difficulty passing urine
You have another medical condition that could affect you taking part in this trial
You have another cancer that could affect the trial treatment and follow up (your doctor can advise you about this)

Trial design

This is a pilot study. It is in 2 parts. Both parts are randomised. In each part you are put into one of 2 groups. Neither you nor your doctor will be able to say which group you are put in.

Part 1 will recruit about 400 men. Half the men will get the standard information about prostate cancer and its treatment. The other half will get the standard information and a DVD/video to watch.

Standard information may include

Booklets about prostate cancer and its treatment
Contact details for further information
The name of a specialist nurse

The DVD/video includes information about

Standard treatment options available
Treatment outcomes
How to decide which treatment is best for you

If you get the DVD/video, you can watch it at home or at the hospital. You are free to watch it as many times as you wish. It takes about 30 minutes to watch.

Whether you decide to have treatment or not, you will be asked to fill in a questionnaire. It will ask you about the choices you made.

If you are suitable for part 2, your doctor will invite you to take part.

Part 2 is a feasibility study. It is looking at the possibility of a phase 3 study to compare the two treatments, radical prostatectomy and brachytherapy.

In part 2 half the men have a radical prostatectomy. The other half have brachytherapy to the prostate. Neither you nor your doctor will be able to say which group you join.

You will be asked to fill in a questionnaire before treatment then 1 month, 4 months, 8 months, 2 years and 5 years after treatment. It will ask about any symptoms you have had and how you are feeling. This is called a quality of life questionnaire.