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

Sponsor:	Japan Clinical Oncology Group
Collaborator:	Ministry of Health, Labour and Welfare, Japan
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00138008

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 III

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:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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:

Related Info This link exits the ClinicalTrials.gov site

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 February 09, 2012