PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer

Study Overview
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Brief Summary
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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 biomarkers related to cancer and help doctors predict how patients will respond to treatment. PURPOSE: This laboratory study is looking at PSA levels and biopsy samples after undergoing implant radiation therapy and luteinizing hormone-releasing hormone agonist therapy in patients with stage I or stage II prostate cancer.

Detailed Description
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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.

Official Title
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Analysis of Biopsy Results at 36 Months After Permanent I-125 Implantation Therapy Plus LHRH-agonist Therapy for Patients With Untreated Intermediate Prostate Cancer.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biopsy 36 month after breacchytherapy<br>Biopsy 36 month after breacchytherapy on protocol JUSMH-BRI-GU05-01. | Other: biopsy<br>* Conduct prostatic needle biopsy at 36-39 months-after brachy therapy. Basic method is by transectal ultra-sound-guided systematic biopsy,; systematic sextant biopsy which involves samples from both seminal vesicles is adopted as much as possible.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of PSA levels and biopsy results at 36 months months | Compare biobsy results and PSA revels at baseline vs. 36 months after brachytherapy. | 36-39 month after PI-125 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer