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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by Japan Clinical Oncology Group
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00138008
First received: August 29, 2005
Last updated: June 13, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: endocrine therapy
Procedure: radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • time to treatment failure (TTF) of bicalutamide [ Time Frame: time to treatment failure (TTF) of bicalutamide ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TTF of protocol treatment [ Time Frame: TTF of protocol treatment ] [ Designated as safety issue: No ]
  • clinical progression free survival [ Time Frame: time to clinical progression ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: overall ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: overall ] [ Designated as safety issue: Yes ]
  • patient-reported quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2004
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: endocrine therapy
Drug: endocrine therapy
Drug: endocrine therapy
Experimental: 2
Procedure/Surgery: radiotherapy
Procedure: radiotherapy
Procedure/Surgery: radiotherapy

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

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138008

Contacts
Contact: Akira Yokomizo, MD, Ph.D. 81-92-642-5603 JCOG_sir@ml.jcog.jp
Contact: Seiji Naito, MD, Ph.D. 81-92-642-5603 JCOG_sir@ml.jcog.jp

Locations
Japan
Nagoya University School of Medicine Recruiting
65 Tsurumai-cho,Showa-ku,Nagoya, Aichi, Japan, 466-8550
Contact: Yoshinari Ono, M.D.    81-52-744-2985      
Akita University School of Medicine Recruiting
1-1-1,Hondo,Akita, Akita, Japan, 010-8543
Contact: Norihiko Tsuchiya, M.D.    81-18-884-6156      
Chiba University, Graduate School of Medicine Recruiting
1-8-1,Inohana,Chuo-ku,Chiba, Chiba, Japan, 260-8670
Contact: Hiroyoshi Suzuki, M.D., Ph.D.    81-43-226-2134      
Chiba Cancer Center Hospital Recruiting
666-2,Nitona-cho,Chuo-ku,Chiba, Chiba, Japan, 260-8717
Contact: Masayuki Maruoka, M.D.    81-43-264-5431      
National Hospital Organization Shikoku Cancer Center Recruiting
13,Horinouchi,Matsuyama, Ehime, Japan, 790-0007
Contact: Katsuyoshi Hashine, M.D.    81-89-932-1111      
Graduate School of Medical Science, Kyushu University Recruiting
3-1-1Maidashi, Higashi-ku,Fukuoka, Fukuoka, Japan, 812-8582
Contact: Akira Yokomizo, MD, Ph.D.    81-92-642-5603      
Kurume University School of Medicine Recruiting
67,Asahi-machi,Kurume, Fukuoka, Japan, 830-0011
Contact: Masanori Noguchi, M.D., Ph.D.    81-942-35-3311      
Gunma University Recruiting
3-39-15,Showa,Maebashi, Gunma, Japan, 371-8511
Contact: Yasuhiro Shibata, M.D., Ph.D.    81-27-220-7111      
Hokkaido University Hospital Recruiting
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
Contact: Nobuo Shinohara, M.D.    81-11-716-1161      
Sapporo Medical University Recruiting
S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan, 060-8543
Contact: Atsushi Takahashi, M.D.    81-11-611-2111      
Kobe University Graduate School of Medicine Recruiting
7-5-2,Kusunoki-cho,Chuo-ku,Kobe, Hyogo, Japan, 650-0017
Contact: Isao Hara, M.D.    81-78-382-6155      
Institute of Clinical Medicine,Tsukuba University Hospital Recruiting
1-1-1,Tennodai,Tsukuba, Ibaraki, Japan, 305-8575
Contact: Naoto Miyanaga, M.D., Ph.D.    81-298-53-3223      
Faculty of Medicine, Kagawa University Recruiting
1750-1,Ikenobe,Miki-cho,Kita, Kagawa, Japan, 761-0793
Contact: Masashi Inui, M.D., Ph.D.    81-87-891-2202      
Kagoshima University,Faculty of Medicine Recruiting
8-35-1,Sakuragaoka,Kagoshima, Kagoshima, Japan, 890-8520
Contact: Kenryu Nishiyama, M.D.    81-99-275-5395      
Kitasato University School of Medicine Recruiting
1-15-1,Kitasato,Sagamihara, Kanagawa, Japan, 228-8555
Contact: Takefumi Satoh, M.D.    81-42-778-9091      
Kyoto University Hospital Recruiting
54,Syogoinkawara,Sakyo-ku,Kyoto, Kyoto, Japan, 606-8507
Contact: Toshiyuki Kamoto, M.D.    81-75-751-3337      
Mie University School of Medicine Recruiting
2-174,Edobashi,Tsu, Mie, Japan, 514-8507
Contact: Kiminobu Arima, M.D.    81-59-232-1111      
Tohoku University Hospital Recruiting
1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi, Japan, 980-8574
Contact: Shigeto Ishidoya, M.D.    81-22-717-7278      
Miyagi Cancer Center Recruiting
47-1,Nodayama,Medeshima-Shiode,Natori, Miyagi, Japan, 981-1293
Contact: Sadafumi Kawamura, M.D.    81-22-384-3151      
Sinshu University Recruiting
3-1-1,Asahi,Matsumoto, Nagano, Japan, 390-8621
Contact: Osamu Ishizuka, M.D., Ph.D.    81-263-37-2661      
Nara Medical University Recruiting
840,Shijo-cho,Kashihara, Nara, Japan, 634-8522
Contact: Kiyohide Fujimoto, M.D.    81-744-22-3051      
Niigata University Medical and Dental Hospital Recruiting
1-754,Asahimachi-dori,Niigata, Niigata, Japan, 951-8520
Contact: Toshiki Tanikawa, M.D., Ph.D.    81-25-227-2289      
Niigata Cancer Center Hospital Recruiting
2-15-3,Kawagishi-cho,Niigata, Niigata, Japan, 951-8566
Contact: Yasuo Kitamura, M.D.    81-25-266-5111      
Kurashiki Central Hospital Recruiting
1-1-1,Miwa,Kurashiki, Okayama, Japan, 710-8602
Contact: Teruyoshi Aoyama, M.D., Ph.D.    81-86-422-0210      
Okayama University Hospital Recruiting
2-5-1,Shikata-cho,Okayama, Okayama, Japan, 700-8558
Contact: Yasutomo Nasu, M.D., Ph.D.    81-86-235-7285      
Osaka Medical Center for Cancer and Cardiovascular Diseases Recruiting
1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka, Japan, 537-8511
Contact: Osamu Maeda, M.D.    81-6-6972-1181      
Shimane University Faculty of Medicine Recruiting
89-1,Enya-cho,Izumo, Shimane, Japan, 693-8501
Contact: Hirofumi Kishi, M.D.    81-853-20-2253      
Hamamatsu University School of Medicine Recruiting
1-20-1,Handayama,Hamamatsu, Shizuoka, Japan, 431-3192
Contact: Tomomi Ushiyama, M.D.    81-53-435-2306      
Sizuoka Cancer Center Recruiting
1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
Contact: Masashi Niwakawa, M.D.    81-55-989-5222      
Tochigi Cancer Center Recruiting
4-9-13,Yohnan,Utsunomiya, Tochigi, Japan, 320-0834
Contact: Kiyotaka Kawashima, M.D.    81-28-658-5151      
Jikei University Hospital Recruiting
3-25-8,Nishishinbashi,Minato-ku, Tokyo, Japan, 105-8461
Contact: Nozomu Furuta, M.D.    81-3-3433-1111      
Keio University Hospital Recruiting
35,Shinanomachi,Shinjuku-ku, Tokyo, Japan, 160-8582
Contact: Jun Nakashima, M.D., Ph.D.    81-3-5363-3825      
National Cancer Center Hospital Recruiting
5-1-1,Tsukiji,Chuo-ku, Tokyo, Japan, 104-0045
Contact: Naoki Matsuoka, M.D.    81-3-3542-2511      
University of Yamanashi Faculty of Medicine Recruiting
1110,Shimokato,Tamaho,Nakakoma, Yamanashi, Japan, 409-3898
Contact: Yoshio Takihana, M.D.    81-55-273-9643      
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Seiji Naito, MD, Ph.D. Graduate School of Medical Science, Kyushu University
  More Information

Additional Information:
No publications provided

Responsible Party: Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00138008     History of Changes
Other Study ID Numbers: JCOG0401, C000000026
Study First Received: August 29, 2005
Last Updated: June 13, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
prostate cancer
radical prostatectomy
PSA failure
RCT
radiation
endocrinotherapy

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

ClinicalTrials.gov processed this record on August 20, 2014