Surgery and Brachytherapy: A Randomized Evaluation. Randomized Controlled Trial of Brachytherapy Versus Radical Prostatectomy in Good Risk Prostate Cancer: A Feasibility Study
- Determine the proportion of patients consenting to the treatment randomization of
brachytherapy vs radical prostatectomy in treating patients with good-risk prostate
- Determine the feasibility of randomization, in terms of average accrual rate per
center, during the last 6 months of recruitment.
- Determine the decisional quality post-treatment in these patients.
- Determine the compliance with allocated treatment in these patients.
- Determine the clinical failure in these patients.
- Determine the PSA relapse in these patients.
- Determine the patient-reported quality of life.
- Compare the toxicity of these regimens.
OUTLINE: This is a multicenter study.
- Part 1 (decision-aid randomization): Patients are stratified according to participating
center. Patients are randomized to 1 of 2 Decision-Aid arms.
- Arm I (standard patient information): Patients receive standard patient
information according to routine clinical practice and preferred materials of each
center. This information typically includes booklets about prostate cancer and its
treatment, contact details for sources of further information (e.g., prostate
support groups, prostate charities, and web-based information), and access to a
specialist nurse as required.
- Arm II (standard patient information + decision aid): In addition to standard
information as described in Arm I, patients are given a 30-minute Decision-Aid
video or DVD to take home. The Decision Aid describes the standard treatment
options available to patients, provides detailed information about treatment
outcomes in relation to individual patient characteristics, and seeks to help
patients apply their own personal values to their treatment decision. Patients may
watch the audio-visual aid as many times as they wish.
Patients who decide to choose a treatment are removed from study; patients who agree to
undergo treatment randomization proceed to part 2 of the study.
- Part 2 (treatment randomization): Patients are stratified according to risk (low risk
vs intermediate risk). Patients are randomized to 1 of 2 treatment arms.
- Arm I (radical prostatectomy): Patients undergo surgery within 60 days of
randomization. The surgical technique for radical prostatectomy may be retropubic,
transperineal, laparoscopic or robotic. Pelvic lymph node surgery is permitted at
the discretion of the treating surgeon. Unilateral or bilateral nerve-sparing
techniques may be used at the discretion of the treating surgeon.
- Arm II (brachytherapy): Patients undergo brachytherapy within 60 days of
randomization. Brachytherapy seeds may be implanted using pre-loaded needles or a
MICK® applicator of either iodine I 125 or palladium Pd 103.
Patient-reported quality-of-life data is collected to assess erectile function, urinary
function, bowel function, and general quality of life at baseline and during follow up.
Patients are followed at 1 and 4 months, every 4 months for 2 years, every 6 months for 3
years, then annually for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Allocation: Randomized, Masking: Open Label
Proportion of patients consenting to the treatment randomization
Leeds Cancer Centre at St. James's University Hospital