Observation or Radical Treatment in Patients With Prostate Cancer
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.
Procedure: conventional surgery
Radiation: external beam radiation therapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START]|
- Disease-specific survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Distant disease-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- PSA relapse/progression after radical intervention [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Initiation of androgen deprivation therapy [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Proportion of patients on the active surveillance arm who receive radical intervention [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Prognostic significance of PSA doubling-time prior to diagnosis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Prognostic significance of molecular biomarkers [ Time Frame: 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||January 2013|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
No Intervention: Active Surveillance
Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression
Active Comparator: Radical Intervention
Radical prostatectomy or radiotherapy based on patient and physician preference
Procedure: conventional surgery
Radical prostatectomyRadiation: brachytherapy
high dose rate temporary seed implant; permanent seed implant.Radiation: external beam radiation therapy
3D conformal radiation therapy; intensity modulated radiation therapy.Procedure: Biopsies
Periodic repeat biopsies
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499174
|Canada, British Columbia|
|Clinical Research Unit at Vancouver Coastal|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, Newfoundland and Labrador|
|Dr. H. Bliss Murphy Cancer Centre|
|St. John's, Newfoundland and Labrador, Canada, AIB 3V6|
|Canada, Nova Scotia|
|QEII Health Sciences Center|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Health Research Institute - General Division|
|Ottawa, Ontario, Canada, K1H 8L6|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|CHUM - Hopital Notre-Dame|
|Montreal, Quebec, Canada, H2L 4M1|
|McGill University - Dept. Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|CHUQ-Pavillon Hotel-Dieu de Quebec|
|Quebec City, Quebec, Canada, G1R 2J6|
|Centre hospitalier universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Study Chair:||Laurence H. Klotz, MD||Edmond Odette Cancer Centre at Sunnybrook|
|Study Chair:||Adam S. Kibel, MD||Washington University Siteman Cancer Center|
|Study Chair:||Martin G. Sanda, MD||Beth Israel Deaconess Medical Center|
|Study Chair:||Ian M. Thompson, MD||The University of Texas Health Science Center at San Antonio|
|Study Chair:||Richard Choo, M.D||Mayo Clinic|
|Study Chair:||Chris Parker, M.D||Royal Marsden Hospital, Sulton, UK|