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

Haruhiko Fukuda

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Procedure: radiotherapy; Drug: endocrine therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00138008

C000000026 (Registry Identifier)

JCOG0401

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: Male

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1

Active Comparator group

Description:

Drug: endocrine therapy

Treatment:

Drug: endocrine therapy

2

Experimental group

Description:

Procedure/Surgery: radiotherapy

Treatment:

Procedure: radiotherapy