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Lead
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
With
Jikei University School of Medicine
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 intermediate-risk prostate cancer.
OUTLINE: Patients received luteinizing hormone releasing-hormone (LHRH) agonist therapy and permanent iodine I 125 implantation on protocol JUSMH-BRI-GU05-01.
Patients undergo blood sample collection and tissue biopsy for biomarker/laboratory analysis at 36 months after receiving brachytherapy and releasing-hormone agonist therapy. PSA levels and biopsy results are compared.
Age
20–75
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer