Observation or Radical Treatment in Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Procedure: conventional surgeryRadiation: brachytherapyRadiation: external beam radiation therapyProcedure: Biopsies
- Registration Number
- NCT00499174
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: Sometimes prostate tumours may not need treatment until they progress. In this case, observation may be sufficient. Radical treatments, such as radical prostatectomy or radiation therapy, may be effective in treating prostate cancer when it is first diagnosed. It is not yet known whether active surveillance is more effective than radical treatment as an initial intervention in favorable prognosis prostate cancer.
PURPOSE: This randomized phase III trial is studying active surveillance to see how well it works compared with radical treatment as an initial intervention in patients with favorable prognosis prostate cancer.
- Detailed Description
OBJECTIVES:
Primary
* To compare disease-specific survival of patients with favorable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis vs active surveillance and selective intervention based on pre-specified biochemical, histological, or clinical progression criteria.
Secondary
* To compare overall survival, quality of life using the EPIC-26, RAND SF-12, and State-Trait Anxiety Inventory, distant disease-free survival, PSA relapse/progression after radical intervention, and initiation of androgen deprivation therapy between the two treatment arms.
* To determine the proportion of patients on the active surveillance arm who receive radical intervention for prostate cancer.
* To determine if PSA doubling-time prior to diagnosis predicts eventual outcome.
* To determine if molecular biomarkers predict outcome.
OUTLINE: This is a prospective, randomized, multicenter study. Patients are stratified by treatment center, ECOG performance status (0 vs 1 or 2), disease stage (T1 vs T2), baseline PSA value (ng/mL or μg/L) (\< 5.0 vs ≥ 5.0 and ≤ 10.0), and age (\< 65 years vs ≥ 65 years). Patients are randomized to 1 of 2 arms.
* Arm I: Patients undergo radical intervention (radical prostatectomy or radiotherapy \[external-beam radiotherapy 5 days a week for 4-8 weeks; permanent prostate brachytherapy; or high-dose rate temporary brachytherapy\], based on patient and physician preference).
* Arm II: Patients undergo active surveillance with radical intervention at the time one or more pre-specified criteria (biochemical progression, histologic/grade progression, and/or clinical progression) are met.
Quality of life is assessed by the EPIC-26, RAND SF-12, and State Anxiety Inventory at baseline, periodically during study treatment, and after completion of radical treatment.
After completion of radical treatment, patients are followed every 6 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radical Intervention Biopsies Radical prostatectomy or radiotherapy based on patient and physician preference Radical Intervention brachytherapy Radical prostatectomy or radiotherapy based on patient and physician preference Radical Intervention external beam radiation therapy Radical prostatectomy or radiotherapy based on patient and physician preference Radical Intervention conventional surgery Radical prostatectomy or radiotherapy based on patient and physician preference
- Primary Outcome Measures
Name Time Method Disease-specific Survival 5 years 6 months Time from the date of randomization to the date of death due to prostate cancer.
- Secondary Outcome Measures
Name Time Method Overall Survival 5 years 6 months Time from randomization to the date of death due to any causes.
Trial Locations
- Locations (13)
Ottawa Health Research Institute - General Division
🇨🇦Ottawa, Ontario, Canada
QEII Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
McGill University - Dept. Oncology
🇨🇦Montreal, Quebec, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec
🇨🇦Quebec City, Quebec, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Centre hospitalier universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Clinical Research Unit at Vancouver Coastal
🇨🇦Vancouver, British Columbia, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada