Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for PSA failure after radical prostatectomy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haruhiko Fukuda
• Collaborator: Ministry of Health, Labour and Welfare, Japan

Criteria

Inclusion Criteria:

• A diagnosis of localized prostate cancer (clinical stage T1-2N0M0) which is treated by radical prostatectomy

• Pathological stage: pT0/2/3 and pN0/x

• Serum level of PSA once reached < 0.1 ng/ml after radical prostatectomy and then increased 0.4 ng/ml

• Serum level of PSA 1.0 ng/ml at entry

• No clinical recurrence based on abdominal and pelvic computed tomography, and a bone scan

• No history of chemotherapy or radiation therapy or endocrine therapy for any cancer

• Ages 20 to 79 years

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• No blood transfusion within 28 days of entry

• Sufficient organ function within 28 days of entry

• Provided written informed consent

Exclusion Criteria:

• Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ

• Mental disease or mental symptoms which would affect participant's decision to participate

• Continuous medication with steroids (exclude external use of steroids for skin)

• Ischemic heart disease or arrhythmia which needs medical treatment

• Poorly controlled hypertension

• Poorly controlled diabetes mellitus

• History of cerebral infarction or myocardial infarction within 6 months

• Liver cirrhosis

• Interstitial pneumonia which requires ventilation assistance, oxygen inhalation, steroids, or diuretic medicine