Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy(JCOG0401)

Phase 3

• Conditions: prostate cancer

• Registration Number: JPRN-C000000026
• Lead Sponsor: Japan Clinical Oncology Group(JCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-22
• Study Completion: 2016-05-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Male
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ; 2) mental disease or mental symptoms which would affect participant's decision to participate; 3) continuous medication of steroids (exclude external use of steroids for skin) ; 4) ischemic heart disease or arrhythmia which needs medical treatment; 5) poorly controlled hypertension; 6) poorly controlleddiabetes mellitus; 7) history of cerebral infarction or myocardial infarction within 6 months; 8) liver cirrhosis 9) interstitial pneumonia which requires ventilation assistance, oxygen inhalation, steroids, or diuretic medicine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TTF of bicalutamide

Secondary Outcome Measures

Name	Time	Method
TTF of protocol treatment, clinical progression free survival, overall survival, adverse events and patient-reported quality of life