PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer (SHIP36B)
|ClinicalTrials.gov Identifier: NCT00898326|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : June 2, 2017
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: biopsy|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||198 participants|
|Official Title:||Analysis of Biopsy Results at 36 Months After Permanent I-125 Implantation Therapy Plus LHRH-agonist Therapy for Patients With Untreated Intermediate Prostate Cancer.|
|Actual Study Start Date :||April 1, 2011|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 2016|
Biopsy 36 month after breacchytherapy
Biopsy 36 month after breacchytherapy on protocol JUSMH-BRI-GU05-01.
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.
- Comparison of PSA levels and biopsy results at 36 months months [ Time Frame: 36-39 month after PI-125 ]Compare biobsy results and PSA revels at baseline vs. 36 months after brachytherapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898326
|Jikei University School of Medicine Hospital|
|Tokyo, Japan, 125-8506|
|Principal Investigator:||Shin Egawa, MD, PhD||Jikei University School of Medicine|