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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00138008
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : September 22, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: endocrine therapy Procedure: radiotherapy Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy (JCOG0401)
Study Start Date : May 2004
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Drug: endocrine therapy
Drug: endocrine therapy
Drug: endocrine therapy
Experimental: 2
Procedure/Surgery: radiotherapy
Procedure: radiotherapy
Procedure/Surgery: radiotherapy

Outcome Measures

Primary Outcome Measures :
  1. time to treatment failure (TTF) of bicalutamide [ Time Frame: time to treatment failure (TTF) of bicalutamide ]

Secondary Outcome Measures :
  1. TTF of protocol treatment [ Time Frame: TTF of protocol treatment ]
  2. clinical progression free survival [ Time Frame: time to clinical progression ]
  3. overall survival [ Time Frame: overall ]
  4. adverse events [ Time Frame: overall ]
  5. patient-reported quality of life [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138008

Nagoya University School of Medicine
Nagoya,Showa-ku,Tsurumai-cho,65, Aichi, Japan, 466-8550
Akita University School of Medicine
Akita,Hondo,1-1-1, Akita, Japan, 010-8543
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan, 260-8670
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan, 260-8717
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
Graduate School of Medical Science, Kyushu University
Fukuoka, Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
Kurume University School of Medicine
Kurume,Asahi-machi,67, Fukuoka, Japan, 830-0011
Gunma University
Maebashi,Showa,3-39-15, Gunma, Japan, 371-8511
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
Sapporo Medical University
S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan, 060-8543
Kobe University Graduate School of Medicine
Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyogo, Japan, 650-0017
Institute of Clinical Medicine,Tsukuba University Hospital
Tsukuba,Tennodai,1-1-1, Ibaraki, Japan, 305-8575
Faculty of Medicine, Kagawa University
Kita,Miki-cho,Ikenobe,1750-1, Kagawa, Japan, 761-0793
Kagoshima University,Faculty of Medicine
Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan, 890-8520
Kitasato University School of Medicine
Sagamihara,Kitasato,1-15-1, Kanagawa, Japan, 228-8555
Kyoto University Hospital
Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan, 606-8507
Mie University School of Medicine
Tsu,Edobashi,2-174, Mie, Japan, 514-8507
Miyagi Cancer Center
Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan, 981-1293
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-8574
Sinshu University
Matsumoto,Asahi,3-1-1, Nagano, Japan, 390-8621
Nara Medical University
Kashihara,Shijo-cho,840, Nara, Japan, 634-8522
Niigata University Medical and Dental Hospital
Niigata,Asahimachi-dori,1-754, Niigata, Japan, 951-8520
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
Kurashiki Central Hospital
Kurashiki,Miwa,1-1-1, Okayama, Japan, 710-8602
Okayama University Hospital
Okayama,Shikata-cho,2-5-1, Okayama, Japan, 700-8558
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
Shimane University Faculty of Medicine
Izumo,Enya-cho,89-1, Shimane, Japan, 693-8501
Hamamatsu University School of Medicine
Hamamatsu,Handayama,1-20-1, Shizuoka, Japan, 431-3192
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan, 411-8777
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, Japan, 320-0834
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
Jikei University Hospital
Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan, 105-8461
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, Japan, 160-8582
University of Yamanashi Faculty of Medicine
Nakakoma,Tamaho,Shimokato,1110, Yamanashi, Japan, 409-3898
Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Study Chair: Seiji Naito, MD, Ph.D. Graduate School of Medical Science, Kyushu University
More Information

Additional Information:
Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00138008     History of Changes
Other Study ID Numbers: JCOG0401
C000000026 ( Registry Identifier: UMIN-CTR )
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Haruhiko Fukuda, Japan Clinical Oncology Group:
prostate cancer
radical prostatectomy
PSA failure

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases