PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer (SHIP36B)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|