Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy
- Conditions
- Prostate Cancer
- Interventions
- Drug: endocrine therapyProcedure: radiotherapy
- Registration Number
- NCT00138008
- Lead Sponsor
- Haruhiko Fukuda
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 endocrine therapy Drug: endocrine therapy 2 radiotherapy Procedure/Surgery: radiotherapy
- Primary Outcome Measures
Name Time Method time to treatment failure (TTF) of bicalutamide time to treatment failure (TTF) of bicalutamide
- Secondary Outcome Measures
Name Time Method TTF of protocol treatment TTF of protocol treatment patient-reported quality of life 1 year overall survival overall clinical progression free survival time to clinical progression adverse events overall
Trial Locations
- Locations (34)
Miyagi Cancer Center
🇯🇵Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama,Horinouchi,13, Ehime, Japan
Sapporo Medical University
🇯🇵S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan
Mie University School of Medicine
🇯🇵Tsu,Edobashi,2-174, Mie, Japan
Sizuoka Cancer Center
🇯🇵Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan
Tochigi Cancer Center
🇯🇵Utsunomiya,Yohnan,4-9-13, Tochigi, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
Chiba University, Graduate School of Medicine
🇯🇵Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan
Kyoto University Hospital
🇯🇵Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan
Nara Medical University
🇯🇵Kashihara,Shijo-cho,840, Nara, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata,Asahimachi-dori,1-754, Niigata, Japan
Nagoya University School of Medicine
🇯🇵Nagoya,Showa-ku,Tsurumai-cho,65, Aichi, Japan
Akita University School of Medicine
🇯🇵Akita,Hondo,1-1-1, Akita, Japan
Hokkaido University Hospital
🇯🇵North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan
Kobe University Graduate School of Medicine
🇯🇵Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyogo, Japan
Tohoku University Hospital
🇯🇵Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Sinshu University
🇯🇵Matsumoto,Asahi,3-1-1, Nagano, Japan
Shimane University Faculty of Medicine
🇯🇵Izumo,Enya-cho,89-1, Shimane, Japan
Hamamatsu University School of Medicine
🇯🇵Hamamatsu,Handayama,1-20-1, Shizuoka, Japan
Chiba Cancer Center Hospital
🇯🇵Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan
Graduate School of Medical Science, Kyushu University
🇯🇵Fukuoka, Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
Faculty of Medicine, Kagawa University
🇯🇵Kita,Miki-cho,Ikenobe,1750-1, Kagawa, Japan
Kagoshima University,Faculty of Medicine
🇯🇵Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan
Kitasato University School of Medicine
🇯🇵Sagamihara,Kitasato,1-15-1, Kanagawa, Japan
Okayama University Hospital
🇯🇵Okayama,Shikata-cho,2-5-1, Okayama, Japan
Kurume University School of Medicine
🇯🇵Kurume,Asahi-machi,67, Fukuoka, Japan
Institute of Clinical Medicine,Tsukuba University Hospital
🇯🇵Tsukuba,Tennodai,1-1-1, Ibaraki, Japan
Keio University Hospital
🇯🇵Shinjuku-ku,Shinanomachi,35, Tokyo, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Kurashiki Central Hospital
🇯🇵Kurashiki,Miwa,1-1-1, Okayama, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan
University of Yamanashi Faculty of Medicine
🇯🇵Nakakoma,Tamaho,Shimokato,1110, Yamanashi, Japan
Gunma University
🇯🇵Maebashi,Showa,3-39-15, Gunma, Japan
Jikei University Hospital
🇯🇵Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan