NCT00499174

Observation or Radical Treatment in Patients With Prostate Cancer

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	conventional surgery	Radical prostatectomy
RADIATION	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

Timeline

• Start date: 2007-12-06
• Primary completion: 2011-12-31
• Completion: 2013-01-10
• First posted: 2007-07-11
• Last updated: 2023-08-23
• Results posted: 2021-05-12

Locations

13 sites across 1 country: Canada