Status:
COMPLETED
Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
The Jikei University School of Medicine
Conditions:
Prostate Cancer
Eligibility:
MALE
20-75 years
Phase:
PHASE3
Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Luteinizing hormone-releasing hormone agonists may lessen the amount of androgens made by the body. Internal radiation uses radioact...
Detailed Description
OBJECTIVES: * To evaluate the biochemical progression-free survival (PFS), overall survival, clinical PFS, and disease-free survival of patients with previously untreated intermediate-risk prostate c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed prostate cancer
- Previously untreated disease
- Intermediate-risk disease, as defined by the following:
- Clinical stage \< T2c
- Prostate-specific antigen (PSA) ≤ 20 ng/mL
- Gleason score \< 8
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- Leukocyte count ≥ 3,000/uL
- Hemoglobin ≥ 10.0 g/dL
- Platelet count ≥ 100,000/uL
- Serum creatinine ≤ 2.0 mg/dL
- ALT and AST ≤ 100 IU/L
- No other cancer requiring treatment
- No poorly controlled hypertension (i.e., diastolic blood pressure ≥ 120 mm Hg)
- No severe psychiatric disorders, including schizophrenia or dementia
- No poorly controlled diabetes
- Considered appropriate for study participation, as determined by the Principal Investigator or Clinical Investigator
- PRIOR CONCURRENT THERAPY:
- No prior drugs for benign prostatic hyperplasia (other than antiandrogen therapy)
- No prior surgery for prostate cancer
- No concurrent steroid drugs (except for ointment)
- No other concurrent antiandrogen therapy
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT00664456
Start Date
April 1 2008
End Date
June 30 2023
Last Update
July 24 2023
Active Locations (1)
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1
The Jikei University School of Medicine
Tokyo, Japan, 125-8506