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

September 20, 2016 updated by: Haruhiko Fukuda

Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy (JCOG0401)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to treatment failure (TTF) of bicalutamide
Time Frame: time to treatment failure (TTF) of bicalutamide
time to treatment failure (TTF) of bicalutamide

Secondary Outcome Measures

Outcome Measure
Time Frame
TTF of protocol treatment
Time Frame: TTF of protocol treatment
TTF of protocol treatment
clinical progression free survival
Time Frame: time to clinical progression
time to clinical progression
overall survival
Time Frame: overall
overall
adverse events
Time Frame: overall
overall
patient-reported quality of life
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haruhiko Fukuda

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCOG0401
  • C000000026 (Registry Identifier: UMIN-CTR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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