Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Biopsy 36 month after breacchytherapy
- description
- Biopsy 36 month after breacchytherapy on protocol JUSMH-BRI-GU05-01.
- interventionNames
- Other: biopsy
Primary outcomes (1)
- measure
- Comparison of PSA levels and biopsy results at 36 months months
- timeFrame
- 36-39 month after PI-125
- description
- Compare biobsy results and PSA revels at baseline vs. 36 months after brachytherapy.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMiki K, Kiba T, Sasaki H, Kido M, Aoki M, Takahashi H, Miyakoda K, Dokiya T, Yamanaka H, Fukushima M, Egawa S. Transperineal prostate brachytherapy, using I-125 seed with or without adjuvant androgen deprivation, in patients with intermediate-risk prostate cancer: study protocol for a phase III, multicenter, randomized, controlled trial. BMC Cancer. 2010 Oct 21;10:572. doi: 10.1186/1471-2407-10-572. PMID 20964826