Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003124
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2002-12
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 stimulate the growth of prostate cancer cells Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens Combining radiation therapy with hormone therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with prostate cancer
PURPOSE Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with prostate cancer
Detailed Description:
OBJECTIVES
Assess the disease free survival of patients with localized adenocarcinoma of the prostate cancer
Evaluate the toxic effects of three dimensional conformal external beam radiotherapy and androgen deprivation in these patients
OUTLINE Patients are stratified according to PSA values and Gleason scores class II versus class IIIIV
Patients receive intramuscular leuprolide acetate every 3 months and oral flutamide tid
Patients are evaluated on a monthly basis for response Patients with unchanged or undetectable prostate specific antigen levels are considered to have reached maximal hormonal response and three dimensional conformal external beam radiotherapy is instituted In addition patients with disease progression are considered to have reached maximal response and three dimensional conformal external beam radiotherapy is instituted Radiotherapy must be administered within 6 months after initiation of leuprolide and flutamide therapy
Hormonal therapy is administered until 9 months of treatment have elapsed
Patients will be followed every 3 months for the first year every 4 months for the second and third years and every 6 months thereafter
PROJECTED ACCRUAL A total of 105 patients will be accrued from biologic class II over 3 years and 58 patients from biologic class III-IV
Assess the disease free survival of patients with localized adenocarcinoma of the prostate cancer
Evaluate the toxic effects of three dimensional conformal external beam radiotherapy and androgen deprivation in these patients
OUTLINE Patients are stratified according to PSA values and Gleason scores class II versus class IIIIV
Patients receive intramuscular leuprolide acetate every 3 months and oral flutamide tid
Patients are evaluated on a monthly basis for response Patients with unchanged or undetectable prostate specific antigen levels are considered to have reached maximal hormonal response and three dimensional conformal external beam radiotherapy is instituted In addition patients with disease progression are considered to have reached maximal response and three dimensional conformal external beam radiotherapy is instituted Radiotherapy must be administered within 6 months after initiation of leuprolide and flutamide therapy
Hormonal therapy is administered until 9 months of treatment have elapsed
Patients will be followed every 3 months for the first year every 4 months for the second and third years and every 6 months thereafter
PROJECTED ACCRUAL A total of 105 patients will be accrued from biologic class II over 3 years and 58 patients from biologic class III-IV
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G97-1356 | None | None | None |
| CPMC-IRB-7947 | None | None | None |