A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START]
- 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
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Laurence H. Klotz, MD
Edmond Odette Cancer Centre at Sunnybrook
United States: Food and Drug Administration