Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT00684905
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
2008-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Phase II Interstitial Brachytherapy Combined With Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide and bicalutamide, may lessen the amount of androgens made by the body. Implant radiation therapy kills tumor cells by placing material such as radioactive iodine directly into or near a tumor. Giving leuprolide and bicalutamide together with implant radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving leuprolide and bicalutamide together with implant radiation therapy and to see how well it works in treating patients with locally recurrent prostate cancer after external-beam radiation therapy.
PURPOSE: This phase II trial is studying the side effects of giving leuprolide and bicalutamide together with implant radiation therapy and to see how well it works in treating patients with locally recurrent prostate cancer after external-beam radiation therapy.
Detailed Description:
OBJECTIVES:
* Determine the feasibility and patient tolerance of interstitial brachytherapy combined with androgen-deprivation therapy for patients with locally recurrent prostate cancer after prior external-beam irradiation.
* Determine the toxicity of interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
* Determine the tumor response to interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
OUTLINE: Patients receive neoadjuvant therapy comprising leuprolide acetate intramuscularly for 3 months and oral bicalutamide once daily for 30 days, beginning on the first day of leuprolide acetate administration. Patients then undergo interstitial brachytherapy implantation with I-125. Following brachytherapy, patients receive adjuvant leuprolide acetate every 3 months for an additional 6 months.
Quality of life is assessed at baseline and at every treatment and follow-up visit.
After completion of study therapy, patients are followed every 3 months for 2 years, every to 4-6 months for 3 years, and then annually thereafter.
* Determine the feasibility and patient tolerance of interstitial brachytherapy combined with androgen-deprivation therapy for patients with locally recurrent prostate cancer after prior external-beam irradiation.
* Determine the toxicity of interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
* Determine the tumor response to interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
OUTLINE: Patients receive neoadjuvant therapy comprising leuprolide acetate intramuscularly for 3 months and oral bicalutamide once daily for 30 days, beginning on the first day of leuprolide acetate administration. Patients then undergo interstitial brachytherapy implantation with I-125. Following brachytherapy, patients receive adjuvant leuprolide acetate every 3 months for an additional 6 months.
Quality of life is assessed at baseline and at every treatment and follow-up visit.
After completion of study therapy, patients are followed every 3 months for 2 years, every to 4-6 months for 3 years, and then annually thereafter.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| 7-00 | OTHER | Mayo Clinic Cancer Center | View | |
| 7-00 | OTHER | Mayo Clinic IRB | View |