Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy
This study is currently recruiting participants.
Verified June 2010 by Japan Clinical Oncology Group
Sponsor:
Japan Clinical Oncology Group
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
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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
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 May 23, 2013