Observation or Radical Treatment in Patients With Prostate Cancer
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.
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.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed adenocarcinoma of the prostate

 -  Diagnosed within 6 months prior to randomization

 -  Patient has been classified as favorable risk as defined by the following:

 -  Clinical stage T1b, T1c, T2a, or T2b at the time of diagnosis

 -  Clinical (diagnostic biopsy) Gleason score ≤ 6

 -  PSA ≤ 10.0 ng/mL

 -  Physical examination, rectal examination, and transrectal ultrasound have been done
 within 6 months prior to randomization and radiographic studies, if indicated, are
 negative for metastasis

 -  Patient is a suitable candidate for radical prostatectomy or radiotherapy

 PATIENT CHARACTERISTICS:

 -  ECOG performance status 0, 1, or 2

 -  Patient has a minimum life expectancy of > 10 years

 -  In centers participating in the quality of life component of the study, the patient is
 able (i.e., sufficiently fluent) and willing to complete the quality of life
 questionnaires in either English or French

 -  No history of other malignancies, except adequately treated non-melanoma skin cancer,
 adequately treated superficial bladder cancer, or other solid tumors curatively
 treated with no evidence of disease for ≥ 5 years from study randomization

 PRIOR CONCURRENT THERAPY:

 -  No previous treatment for prostate cancer, including surgery (excluding biopsy and
 TURP), radiotherapy, or androgen deprivation therapy for greater than 3 months

 -  No planned androgen therapy except in the context of radical therapy