search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
endocrine therapy
radiotherapy
Sponsored by
Haruhiko Fukuda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, radical prostatectomy, PSA failure, RCT, radiation, endocrinotherapy

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nagoya University School of Medicine
  • Akita University School of Medicine
  • Chiba University, Graduate School of Medicine
  • Chiba Cancer Center Hospital
  • National Hospital Organization Shikoku Cancer Center
  • Graduate School of Medical Science, Kyushu University
  • Kurume University School of Medicine
  • Gunma University
  • Hokkaido University Hospital
  • Sapporo Medical University
  • Kobe University Graduate School of Medicine
  • Institute of Clinical Medicine,Tsukuba University Hospital
  • Faculty of Medicine, Kagawa University
  • Kagoshima University,Faculty of Medicine
  • Kitasato University School of Medicine
  • Kyoto University Hospital
  • Mie University School of Medicine
  • Miyagi Cancer Center
  • Tohoku University Hospital
  • Sinshu University
  • Nara Medical University
  • Niigata University Medical and Dental Hospital
  • Niigata Cancer Center Hospital
  • Kurashiki Central Hospital
  • Okayama University Hospital
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Shimane University Faculty of Medicine
  • Hamamatsu University School of Medicine
  • Sizuoka Cancer Center
  • Tochigi Cancer Center
  • National Cancer Center Hospital
  • Jikei University Hospital
  • Keio University Hospital
  • University of Yamanashi Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Drug: endocrine therapy

Procedure/Surgery: radiotherapy

Outcomes

Primary Outcome Measures

time to treatment failure (TTF) of bicalutamide

Secondary Outcome Measures

TTF of protocol treatment
clinical progression free survival
overall survival
adverse events
patient-reported quality of life

Full Information

First Posted
August 29, 2005
Last Updated
September 20, 2016
Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
search

1. Study Identification

Unique Protocol Identification Number
NCT00138008
Brief Title
Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy
Official Title
Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy (JCOG0401)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, radical prostatectomy, PSA failure, RCT, radiation, endocrinotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Drug: endocrine therapy
Arm Title
2
Arm Type
Experimental
Arm Description
Procedure/Surgery: radiotherapy
Intervention Type
Drug
Intervention Name(s)
endocrine therapy
Intervention Description
Drug: endocrine therapy
Intervention Type
Procedure
Intervention Name(s)
radiotherapy
Intervention Description
Procedure/Surgery: radiotherapy
Primary Outcome Measure Information:
Title
time to treatment failure (TTF) of bicalutamide
Time Frame
time to treatment failure (TTF) of bicalutamide
Secondary Outcome Measure Information:
Title
TTF of protocol treatment
Time Frame
TTF of protocol treatment
Title
clinical progression free survival
Time Frame
time to clinical progression
Title
overall survival
Time Frame
overall
Title
adverse events
Time Frame
overall
Title
patient-reported quality of life
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seiji Naito, MD, Ph.D.
Organizational Affiliation
Graduate School of Medical Science, Kyushu University
Official's Role
Study Chair
Facility Information:
Facility Name
Nagoya University School of Medicine
City
Nagoya,Showa-ku,Tsurumai-cho,65
State/Province
Aichi
ZIP/Postal Code
466-8550
Country
Japan
Facility Name
Akita University School of Medicine
City
Akita,Hondo,1-1-1
State/Province
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Chiba University, Graduate School of Medicine
City
Chiba,Chuo-ku,Inohana,1-8-1
State/Province
Chiba
ZIP/Postal Code
260-8670
Country
Japan
Facility Name
Chiba Cancer Center Hospital
City
Chiba,Chuo-ku,Nitona-cho,666-2
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama,Horinouchi,13
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
Graduate School of Medical Science, Kyushu University
City
Fukuoka, Higashi-ku,Maidashi,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kurume University School of Medicine
City
Kurume,Asahi-machi,67
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Gunma University
City
Maebashi,Showa,3-39-15
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Hokkaido University Hospital
City
North-14 West-5 Kita-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Sapporo Medical University
City
S-1,W-16,Chuo-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Kobe University Graduate School of Medicine
City
Kobe,Chuo-ku,Kusunoki-cho,7-5-2
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Institute of Clinical Medicine,Tsukuba University Hospital
City
Tsukuba,Tennodai,1-1-1
State/Province
Ibaraki
ZIP/Postal Code
305-8575
Country
Japan
Facility Name
Faculty of Medicine, Kagawa University
City
Kita,Miki-cho,Ikenobe,1750-1
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kagoshima University,Faculty of Medicine
City
Kagoshima,Sakuragaoka,8-35-1
State/Province
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kitasato University School of Medicine
City
Sagamihara,Kitasato,1-15-1
State/Province
Kanagawa
ZIP/Postal Code
228-8555
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto,Sakyo-ku,Syogoinkawara,54
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Mie University School of Medicine
City
Tsu,Edobashi,2-174
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Miyagi Cancer Center
City
Natori,Medeshima-Shiode,Nodayama,47-1
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai,Aoba-ku,Seiryo-machi,1-1
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Sinshu University
City
Matsumoto,Asahi,3-1-1
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Nara Medical University
City
Kashihara,Shijo-cho,840
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata,Asahimachi-dori,1-754
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata,Kawagishi-cho,2-15-3
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki,Miwa,1-1-1
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama,Shikata-cho,2-5-1
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka,Higashinari-ku,Nakamichi,1-3-3
State/Province
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Shimane University Faculty of Medicine
City
Izumo,Enya-cho,89-1
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Hamamatsu University School of Medicine
City
Hamamatsu,Handayama,1-20-1
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Sizuoka Cancer Center
City
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya,Yohnan,4-9-13
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku,Tsukiji,5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Jikei University Hospital
City
Minato-ku,Nishishinbashi,3-25-8
State/Province
Tokyo
ZIP/Postal Code
105-8461
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku,Shinanomachi,35
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
University of Yamanashi Faculty of Medicine
City
Nakakoma,Tamaho,Shimokato,1110
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.jcog.jp/
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs