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

NCT00138008 | Completed Phase 3 DMC

• 2 other identifiers: JCOG0401C000000026
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 34

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate cancer; radical prostatectomy; PSA failure; RCT; radiation; endocrinotherapy

Outcome Measures

Primary Outcomes (1)

• time to treatment failure (TTF) of bicalutamide

  time to treatment failure (TTF) of bicalutamide

Secondary Outcomes (5)

• TTF of protocol treatment

  TTF of protocol treatment

• clinical progression free survival

  time to clinical progression

• overall survival

  overall

• adverse events

  overall

• patient-reported quality of life

  1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: endocrine therapy

Drug: endocrine therapy

2

EXPERIMENTAL

Procedure/Surgery: radiotherapy

Procedure: radiotherapy

Interventions

endocrine therapy DRUG

Drug: endocrine therapy

1

radiotherapy PROCEDURE

Procedure/Surgery: radiotherapy

2

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haruhiko Fukuda: lead
• Ministry of Health, Labour and Welfare, Japan: collaborator

Study Sites (34)

Nagoya University School of Medicine

Nagoya,Showa-ku,Tsurumai-cho,65, Aichi-ken, 466-8550, Japan

Location

Akita University School of Medicine

Akita,Hondo,1-1-1, Akita, 010-8543, Japan

Location

Chiba University, Graduate School of Medicine

Chiba,Chuo-ku,Inohana,1-8-1, Chiba, 260-8670, Japan

Location

Chiba Cancer Center Hospital

Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, 260-8717, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, 790-0007, Japan

Location

Graduate School of Medical Science, Kyushu University

Fukuoka, Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582, Japan

Location

Kurume University School of Medicine

Kurume,Asahi-machi,67, Fukuoka, 830-0011, Japan

Location

Gunma University

Maebashi,Showa,3-39-15, Gunma, 371-8511, Japan

Location

Hokkaido University Hospital

North-14 West-5 Kita-ku,Sapporo, Hokkaido, 060-8648, Japan

Location

Sapporo Medical University

S-1,W-16,Chuo-ku,Sapporo, Hokkaido, 060-8543, Japan

Location

Kobe University Graduate School of Medicine

Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyōgo, 650-0017, Japan

Location

Institute of Clinical Medicine,Tsukuba University Hospital

Tsukuba,Tennodai,1-1-1, Ibaraki, 305-8575, Japan

Location

Faculty of Medicine, Kagawa University

Kita,Miki-cho,Ikenobe,1750-1, Kagawa-ken, 761-0793, Japan

Location

Kagoshima University,Faculty of Medicine

Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, 890-8520, Japan

Location

Kitasato University School of Medicine

Sagamihara,Kitasato,1-15-1, Kanagawa, 228-8555, Japan

Location

Kyoto University Hospital

Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, 606-8507, Japan

Location

Mie University School of Medicine

Tsu,Edobashi,2-174, Mie-ken, 514-8507, Japan

Location

Miyagi Cancer Center

Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, 981-1293, Japan

Location

Tohoku University Hospital

Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574, Japan

Location

Sinshu University

Matsumoto,Asahi,3-1-1, Nagano, 390-8621, Japan

Location

Nara Medical University

Kashihara,Shijo-cho,840, Nara, 634-8522, Japan

Location

Niigata University Medical and Dental Hospital

Niigata,Asahimachi-dori,1-754, Niigata, 951-8520, Japan

Location

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566, Japan

Location

Kurashiki Central Hospital

Kurashiki,Miwa,1-1-1, Okayama-ken, 710-8602, Japan

Location

Okayama University Hospital

Okayama,Shikata-cho,2-5-1, Okayama-ken, 700-8558, Japan

Location

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511, Japan

Location

Shimane University Faculty of Medicine

Izumo,Enya-cho,89-1, Shimane, 693-8501, Japan

Location

Hamamatsu University School of Medicine

Hamamatsu,Handayama,1-20-1, Shizuoka, 431-3192, Japan

Location

Sizuoka Cancer Center

Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, 411-8777, Japan

Location

Tochigi Cancer Center

Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834, Japan

Location

National Cancer Center Hospital

Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045, Japan

Location

Jikei University Hospital

Minato-ku,Nishishinbashi,3-25-8, Tokyo, 105-8461, Japan

Location

Keio University Hospital

Shinjuku-ku,Shinanomachi,35, Tokyo, 160-8582, Japan

Location

University of Yamanashi Faculty of Medicine

Nakakoma,Tamaho,Shimokato,1110, Yamanashi, 409-3898, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Seiji Naito, MD, Ph.D.

  Graduate School of Medical Science, Kyushu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: JCOG Data Center

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: May 1, 2004
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

JP (34)