Status:
COMPLETED
PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
Jikei University School of Medicine
Conditions:
Prostate Cancer
Eligibility:
MALE
20-75 years
Brief Summary
RATIONALE: Studying samples of blood and tissue from patients with prostate cancer after receiving implant radiation therapy and luteinizing hormone-releasing hormone agonist may help doctors identify...
Detailed Description
OBJECTIVES: * To analyze biopsy results at 36 months after permanent iodine I 125 implantation therapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy for patients with untreated int...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed prostate cancer
- Previously untreated disease prior to participation on protocol JUSMH-BRI-GU05-01
- Intermediate-risk disease as defined by the following:
- Clinical stage \< T2c
- Prostate-specific antigen (PSA) ≤ 20 ng/mL
- Gleason score \< 8
- Previously enrolled on protocol JUSMH-BRI-GU05-01
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- WBC ≥ 2,000/μL
- Hemoglobin ≥ 10.0 g/dL
- Platelet count ≥ 100,000/μL
- Serum creatine level ≤ 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 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00898326
Start Date
April 1 2011
End Date
December 31 2016
Last Update
June 2 2017
Active Locations (1)
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1
Jikei University School of Medicine Hospital
Tokyo, Japan, 125-8506