A phase III study of active surveillance therapy against radical treatment in patients diagnosed with favourable risk prostate cancer (START)

Phase 3

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12611000027910
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Male
• Target Recruitment: 2130

Inclusion Criteria

Patients must fulfil all of the following criteria to be eligible for admission to the study: * Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization. & Patient has been classified as favourable risk as defined by the following: * Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis; Clinical (diagnostic biopsy) Gleason sum < 7; PSA < 10.0 ng/ml (ug/L) Note: patients who have received prior treatment with 5-alpha reductase inhibitors (5ARI) must adhere to the following criteria: * < 2 months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 10.0 (ng/ml or ug/L) to be eligible. * 2-6 months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 7.0 (ng/ml or ug/L) to be eligible. * > 6 months months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 5.0 (ng/ml or ug/L) to be eligible. * 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. * No previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, and androgen deprivation therapy for greater than 3 months. * ECOG Performance Status 0, 1 or 2. * Patient has a minimum life expectancy of > 10 years. * The patient is willing to complete the quality of life questionnaires in English unless unable due to illiteracy in English, loss of sight, or other equivalent reason. * Patient consent has been obtained according to local Institutional and/or University Human Experimentation Committee requirements. * Patient is accessible for treatment and follow-up. * Protocol treatment is to begin within 90 days of randomisation.

Exclusion Criteria

Patients who fulfil any of the following criteria are not eligible for admission to the study:
* History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumours curatively treated with no evidence of disease for > 5 years from randomisation.
* Planned androgen therapy except in the context of radical therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified