Implant Radiation Therapy or Surgery in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Procedure: BrachytherapyProcedure: Radical Prostatectomy
- Registration Number
- NCT01098331
- Lead Sponsor
- University of Southampton
- Brief Summary
RATIONALE: Receiving standard information and watching a video or DVD at home that describes treatment options and treatment outcomes may help patients decide to receive treatment in a clinical trial.
PURPOSE: This randomized clinical trial is studying implant radiation therapy to see how well it works compared with surgery in treating patients with prostate cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the proportion of patients consenting to the treatment randomization of brachytherapy vs radical prostatectomy in treating patients with good-risk prostate cancer.
* Determine the feasibility of randomization, in terms of average accrual rate per center, during the last 6 months of recruitment.
Secondary
* 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm Rx2: Brachytherapy Brachytherapy Arm Rx2: Brachytherapy Arm Rx1: Radical Prostatectomy Radical Prostatectomy Arm Rx1: Radical Prostatectomy
- Primary Outcome Measures
Name Time Method Proportion of patients consenting to the treatment randomization 6 months Feasibility of randomization in terms of average accrual rate per center during the last 6 months of recruitment 6 months
- Secondary Outcome Measures
Name Time Method Compliance with allocated treatment 6 months
Trial Locations
- Locations (1)
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom