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

NCT ID: NCT00138008

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Drug: endocrine therapy

Group Type: ACTIVE_COMPARATOR

endocrine therapy

Intervention Type: DRUG

Drug: endocrine therapy

2

Procedure/Surgery: radiotherapy

Group Type: EXPERIMENTAL

radiotherapy

Intervention Type: PROCEDURE

Procedure/Surgery: radiotherapy

Interventions

endocrine therapy

Drug: endocrine therapy

Intervention Type: DRUG

radiotherapy

Procedure/Surgery: radiotherapy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role: collaborator

Haruhiko Fukuda

OTHER

Sponsor Role: lead

Responsible Party

Haruhiko Fukuda

JCOG Data Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seiji Naito, MD, Ph.D.

Role: STUDY_CHAIR

Graduate School of Medical Science, Kyushu University

Locations

Nagoya University School of Medicine

Nagoya,Showa-ku,Tsurumai-cho,65, Aichi-ken, Japan

Akita University School of Medicine

Akita,Hondo,1-1-1, Akita, Japan

Chiba University, Graduate School of Medicine

Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan

Chiba Cancer Center Hospital

Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, Japan

Graduate School of Medical Science, Kyushu University

Fukuoka, Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan

Kurume University School of Medicine

Kurume,Asahi-machi,67, Fukuoka, Japan

Gunma University

Maebashi,Showa,3-39-15, Gunma, Japan

Hokkaido University Hospital

North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan

Sapporo Medical University

S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan

Kobe University Graduate School of Medicine

Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyōgo, Japan

Institute of Clinical Medicine,Tsukuba University Hospital

Tsukuba,Tennodai,1-1-1, Ibaraki, Japan

Faculty of Medicine, Kagawa University

Kita,Miki-cho,Ikenobe,1750-1, Kagawa-ken, Japan

Kagoshima University,Faculty of Medicine

Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, Japan

Kitasato University School of Medicine

Sagamihara,Kitasato,1-15-1, Kanagawa, Japan

Kyoto University Hospital

Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan

Mie University School of Medicine

Tsu,Edobashi,2-174, Mie-ken, Japan

Miyagi Cancer Center

Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan

Tohoku University Hospital

Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan

Sinshu University

Matsumoto,Asahi,3-1-1, Nagano, Japan

Nara Medical University

Kashihara,Shijo-cho,840, Nara, Japan

Niigata University Medical and Dental Hospital

Niigata,Asahimachi-dori,1-754, Niigata, Japan

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho,2-15-3, Niigata, Japan

Kurashiki Central Hospital

Kurashiki,Miwa,1-1-1, Okayama-ken, Japan

Okayama University Hospital

Okayama,Shikata-cho,2-5-1, Okayama-ken, Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 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

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

Jikei University Hospital

Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan

Keio University Hospital

Shinjuku-ku,Shinanomachi,35, Tokyo, Japan

University of Yamanashi Faculty of Medicine

Nakakoma,Tamaho,Shimokato,1110, Yamanashi, Japan

Countries

Japan

Related Links

http://www.jcog.jp/

Related Info

Other Identifiers

C000000026

Identifier Type: REGISTRY

Identifier Source: secondary_id

JCOG0401

Identifier Type: -

Identifier Source: org_study_id