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A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START]

Phase 3
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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
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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-specific survival

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Laurence H. Klotz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Edmond Odette Cancer Centre at Sunnybrook


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

January 2013

Related Keywords:

  • Prostate Cancer
  • stage II prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms