To evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for PSA failure after radical prostatectomy.

Condition	Intervention	Phase
Prostate Cancer	Drug: endocrine therapy  Procedure: radiotherapy±endocrine therapy	Phase III

Further Study Details: 

Primary Outcomes: TTF of bicalutamide
Secondary Outcomes: TTF of protocol treatment; clinical progression free survival; overall survival; adverse events; patient-reported quality of life
Expected Total Enrollment:  200

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.

Ages Eligible for Study:  20 Years   -   79 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

1. A diagnosis of localized prostate cancer (clinical stage T1-2N0M0) which is treated by radical prostatectomy
2. pathological stage: pT0/2/3 and pN0/x
3. the serum level of PSA once reached < 0.1 ng/ml after radical prostatectomy and then increased 0.4 ng/ml
4. the serum level of PSA 1.0 ng/ml at the entry
5. no clinical recurrence based on abdominal and pelvic computed tomography, and a bone scan
6. no history of chemotherapy or radiation therapy or endocrine therapy for any cancer
7. age 20 and 79 years
8. an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9. no blood transfusion within 28 days of entry
10. a sufficient organ function within 28 days of entry
11. provided written informed consent

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 controlled diabetes 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00138008

Akira Yokomizo, MD, Ph.D.      81-92-642-5603    JCOG_sir@ml.jcog.jp
Seiji Naito, MD, Ph.D.      81-92-642-5603    JCOG_sir@ml.jcog.jp

Japan, Fukuoka-shi
      Graduate School of Medical Science, Kyushu University, 3-1-1Maidashi, Higashi-ku,  Fukuoka-shi,  812-8582,  Japan; Recruiting

Study chairs or principal investigators

Seiji Naito, MD, Ph.D.,  Study Chair,  Graduate School of Medical Science, Kyushu University   

Study ID Numbers:  JCOG0401; C000000026
Last Updated:  August 29, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00138008
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-08-30