Trials / Completed
CompletedNCT00898326
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 198 (actual)
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Academic / Other
- Sex
- Male
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | biopsy | 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. |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2016-12-31
- Completion
- 2016-12-31
- First posted
- 2009-05-12
- Last updated
- 2017-06-02
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00898326. Inclusion in this directory is not an endorsement.