Status:
COMPLETED
Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy
Lead Sponsor:
Haruhiko Fukuda
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Prostate Cancer
Eligibility:
MALE
20-79 years
Phase:
PHASE3
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 pros...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00138008
Start Date
May 1 2004
End Date
May 1 2016
Last Update
September 22 2016
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Nagoya University School of Medicine
Nagoya,Showa-ku,Tsurumai-cho,65, Aichi-ken, Japan, 466-8550
2
Akita University School of Medicine
Akita,Hondo,1-1-1, Akita, Japan, 010-8543
3
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan, 260-8670
4
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan, 260-8717