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

Study Overview
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Brief Summary
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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.

Detailed Description
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A randomized controlled trial is conducted in Japan to evaluate radiotherapy followed by endocrine therapy for PSA failure after radical prostatectomy. Patients who have PSA failure after radical prostatectomy under a diagnosis of localized prostate cancer (T1-2 N0M0) are randomized into treatment group of either radiotherapy followed by endocrine therapy or endocrine therapy alone. Urologic Oncology Study Group (UOSG) in the JCOG composed of 36 specialized institutions will recruit 200 patients. The primary endpoint is time to treatment failure (TTF) of bicalutamide and secondary endpoints are TTF of protocol treatment, progression free survival, overall survival, adverse events and quality of life (QOL). The Clinical Trial Review Committee of the Japan Clinical Oncology Group (JCOG) approved the protocol on April 13, 2004, and the study was activated on May 17, 2004.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: endocrine therapy
* Procedure: radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Drug: endocrine therapy | Drug: endocrine therapy<br>* Drug: endocrine therapy<br>|
| Experimental: 2<br>Procedure/Surgery: radiotherapy | Procedure: radiotherapy<br>* Procedure/Surgery: radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to treatment failure (TTF) of bicalutamide |  | time to treatment failure (TTF) of bicalutamide | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TTF of protocol treatment |  | TTF of protocol treatment | 
| clinical progression free survival |  | time to clinical progression | 
| overall survival |  | overall | 
| adverse events |  | overall | 
| patient-reported quality of life |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSA failure, prostate cancer, radical prostatectomy, RCT, radiation, endocrinotherapy