Clinical trial NCT00138008: Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy
Official title: Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy (JCOG0401)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
radical prostatectomy
PSA failure
RCT
radiation
endocrinotherapy
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-08-30
Enrollment: 200
Sex: MALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: time to treatment failure (TTF) of bicalutamide
timeFrame: time to treatment failure (TTF) of bicalutamide
Secondary outcomes:
measure: TTF of protocol treatment
timeFrame: TTF of protocol treatment
measure: clinical progression free survival
timeFrame: time to clinical progression
measure: overall survival
timeFrame: overall
measure: adverse events
timeFrame: overall
measure: patient-reported quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Nagoya,Showa-ku,Tsurumai-cho,65
country: Japan
facility: Nagoya University School of Medicine
state: Aichi
city: Akita,Hondo,1-1-1
country: Japan
facility: Akita University School of Medicine
state: Akita
city: Chiba,Chuo-ku,Inohana,1-8-1
country: Japan
facility: Chiba University, Graduate School of Medicine
state: Chiba
city: Chiba,Chuo-ku,Nitona-cho,666-2
country: Japan
facility: Chiba Cancer Center Hospital
state: Chiba
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Fukuoka, Higashi-ku,Maidashi,3-1-1
country: Japan
facility: Graduate School of Medical Science, Kyushu University
state: Fukuoka
city: Kurume,Asahi-machi,67
country: Japan
facility: Kurume University School of Medicine
state: Fukuoka
city: Maebashi,Showa,3-39-15
country: Japan
facility: Gunma University
state: Gunma
city: North-14 West-5 Kita-ku,Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: S-1,W-16,Chuo-ku,Sapporo
country: Japan
facility: Sapporo Medical University
state: Hokkaido
city: Kobe,Chuo-ku,Kusunoki-cho,7-5-2
country: Japan
facility: Kobe University Graduate School of Medicine
state: Hyogo
city: Tsukuba,Tennodai,1-1-1
country: Japan
facility: Institute of Clinical Medicine,Tsukuba University Hospital
state: Ibaraki
city: Kita,Miki-cho,Ikenobe,1750-1
country: Japan
facility: Faculty of Medicine, Kagawa University
state: Kagawa
city: Kagoshima,Sakuragaoka,8-35-1
country: Japan
facility: Kagoshima University,Faculty of Medicine
state: Kagoshima
city: Sagamihara,Kitasato,1-15-1
country: Japan
facility: Kitasato University School of Medicine
state: Kanagawa
city: Kyoto,Sakyo-ku,Syogoinkawara,54
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Tsu,Edobashi,2-174
country: Japan
facility: Mie University School of Medicine
state: Mie
city: Natori,Medeshima-Shiode,Nodayama,47-1
country: Japan
facility: Miyagi Cancer Center
state: Miyagi
city: Sendai,Aoba-ku,Seiryo-machi,1-1
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Matsumoto,Asahi,3-1-1
country: Japan
facility: Sinshu University
state: Nagano
city: Kashihara,Shijo-cho,840
country: Japan
facility: Nara Medical University
state: Nara
city: Niigata,Asahimachi-dori,1-754
country: Japan
facility: Niigata University Medical and Dental Hospital
state: Niigata
city: Niigata,Kawagishi-cho,2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Kurashiki,Miwa,1-1-1
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Okayama,Shikata-cho,2-5-1
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Osaka,Higashinari-ku,Nakamichi,1-3-3
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka
city: Izumo,Enya-cho,89-1
country: Japan
facility: Shimane University Faculty of Medicine
state: Shimane
city: Hamamatsu,Handayama,1-20-1
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
city: Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
country: Japan
facility: Sizuoka Cancer Center
state: Shizuoka
city: Utsunomiya,Yohnan,4-9-13
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Chuo-ku,Tsukiji,5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Minato-ku,Nishishinbashi,3-25-8
country: Japan
facility: Jikei University Hospital
state: Tokyo
city: Shinjuku-ku,Shinanomachi,35
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Nakakoma,Tamaho,Shimokato,1110
country: Japan
facility: University of Yamanashi Faculty of Medicine
state: Yamanashi
Study officials:
affiliation: Graduate School of Medical Science, Kyushu University
name: Seiji Naito, MD, Ph.D.
role: STUDY_CHAIR
References: