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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00898326

Acronym

SHIP36B

Enrollment

198

Registered

2009-05-12

Start date

2011-04-01

Completion date

2016-12-31

Last updated

2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

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 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

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.

Interventions

OTHERbiopsy

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026