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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138008
• Other study ID #: JCOG0401
• Secondary ID: C000000026
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: September 20, 2016
• Start date: May 2004
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• endocrine therapy
Drug: endocrine therapy

Procedure:
• radiotherapy
Procedure/Surgery: radiotherapy

Locations

Country	Name	City	State
Japan	Akita University School of Medicine	Akita,Hondo,1-1-1	Akita
Japan	Chiba University, Graduate School of Medicine	Chiba,Chuo-ku,Inohana,1-8-1	Chiba
Japan	Chiba Cancer Center Hospital	Chiba,Chuo-ku,Nitona-cho,666-2	Chiba
Japan	National Cancer Center Hospital	Chuo-ku,Tsukiji,5-1-1	Tokyo
Japan	Graduate School of Medical Science, Kyushu University	Fukuoka, Higashi-ku,Maidashi,3-1-1	Fukuoka
Japan	Hamamatsu University School of Medicine	Hamamatsu,Handayama,1-20-1	Shizuoka
Japan	Shimane University Faculty of Medicine	Izumo,Enya-cho,89-1	Shimane
Japan	Kagoshima University,Faculty of Medicine	Kagoshima,Sakuragaoka,8-35-1	Kagoshima
Japan	Nara Medical University	Kashihara,Shijo-cho,840	Nara
Japan	Faculty of Medicine, Kagawa University	Kita,Miki-cho,Ikenobe,1750-1	Kagawa
Japan	Kobe University Graduate School of Medicine	Kobe,Chuo-ku,Kusunoki-cho,7-5-2	Hyogo
Japan	Kurashiki Central Hospital	Kurashiki,Miwa,1-1-1	Okayama
Japan	Kurume University School of Medicine	Kurume,Asahi-machi,67	Fukuoka
Japan	Kyoto University Hospital	Kyoto,Sakyo-ku,Syogoinkawara,54	Kyoto
Japan	Gunma University	Maebashi,Showa,3-39-15	Gunma
Japan	Sinshu University	Matsumoto,Asahi,3-1-1	Nagano
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama,Horinouchi,13	Ehime
Japan	Jikei University Hospital	Minato-ku,Nishishinbashi,3-25-8	Tokyo
Japan	Nagoya University School of Medicine	Nagoya,Showa-ku,Tsurumai-cho,65	Aichi
Japan	University of Yamanashi Faculty of Medicine	Nakakoma,Tamaho,Shimokato,1110	Yamanashi
Japan	Miyagi Cancer Center	Natori,Medeshima-Shiode,Nodayama,47-1	Miyagi
Japan	Niigata University Medical and Dental Hospital	Niigata,Asahimachi-dori,1-754	Niigata
Japan	Niigata Cancer Center Hospital	Niigata,Kawagishi-cho,2-15-3	Niigata
Japan	Hokkaido University Hospital	North-14 West-5 Kita-ku,Sapporo	Hokkaido
Japan	Okayama University Hospital	Okayama,Shikata-cho,2-5-1	Okayama
Japan	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka,Higashinari-ku,Nakamichi,1-3-3	Osaka
Japan	Sapporo Medical University	S-1,W-16,Chuo-ku,Sapporo	Hokkaido
Japan	Kitasato University School of Medicine	Sagamihara,Kitasato,1-15-1	Kanagawa
Japan	Tohoku University Hospital	Sendai,Aoba-ku,Seiryo-machi,1-1	Miyagi
Japan	Keio University Hospital	Shinjuku-ku,Shinanomachi,35	Tokyo
Japan	Sizuoka Cancer Center	Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007	Shizuoka
Japan	Mie University School of Medicine	Tsu,Edobashi,2-174	Mie
Japan	Institute of Clinical Medicine,Tsukuba University Hospital	Tsukuba,Tennodai,1-1-1	Ibaraki
Japan	Tochigi Cancer Center	Utsunomiya,Yohnan,4-9-13	Tochigi

Sponsors (2)

Lead Sponsor	Collaborator
Haruhiko Fukuda	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to treatment failure (TTF) of bicalutamide		time to treatment failure (TTF) of bicalutamide	No
Secondary	TTF of protocol treatment		TTF of protocol treatment	No
Secondary	clinical progression free survival		time to clinical progression	No
Secondary	overall survival		overall	No
Secondary	adverse events		overall	Yes
Secondary	patient-reported quality of life		1 year	No

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