Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003653
Status:
COMPLETED
Last Update Posted:
2021-06-23
First Post:
1999-11-01
Brief Title:
Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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 may fight prostate cancer by reducing the production of androgens It is not yet known which androgen suppression regimen is more effective for prostate cancer
PURPOSE This randomized phase III trial is studying two hormone therapy regimens and comparing them to see how well they work in treating patients with rising PSA levels following radiation therapy for prostate cancer
PURPOSE This randomized phase III trial is studying two hormone therapy regimens and comparing them to see how well they work in treating patients with rising PSA levels following radiation therapy for prostate cancer
Detailed Description:
OBJECTIVES
Compare the survival of prostate cancer patients with prostate-specific antigen progression in the clinical absence of distant metastases after prior radical radiotherapy treated with intermittent androgen suppression IAS vs continuous androgen deprivation CAD
Compare the time to the development of hormone resistance in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the serum cholesterol and HDLLDL levels at 3 years with those at baseline and compare them annually in patients treated with these regimens
Evaluate the duration of treatment and non-treatment intervals time to testosterone recovery return to pre-therapy levels and time to recover potency in patients treated with IAS
OUTLINE This is a randomized multicenter study Patients are stratified according to prior radical prostatectomy yes vs no time since completion of prior radical radiotherapy 1 to 3 years vs 3 years or more baseline prostate-specific antigen PSA value 3-15 ngmL vs greater than 15 ngmL and prior hormonal therapy neo-adjuvant concurrent or adjuvant cytoreduction in association with the radical radiotherapy treatment or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization yes vs no Patients are randomized to one of two treatment arms
Arm I Patients undergo intermittent androgen suppression IAS Patients receive luteinizing hormone-releasing hormone LHRH analog buserelin BSRL goserelin ZDX or leuprolide LEUP and an antiandrogen nilutamide ANAN flutamide FLUT bicalutamide CDX or cyproterone acetate CPTR for 8 months Patients receive LHRH analog by subcutaneous SC or intramuscular IM implant every 1-4 months beginning within 5 days of randomization and oral antiandrogen 1-3 times daily depending on the actual LHRH analog and antiandrogen PSA levels are monitored every 2 months If PSA falls to normal during the 8-month treatment period therapy stops until levels rise to 10 ngmL at which time IAS resumes for another 8-month period IAS continues as long as PSA levels are controlled At the time of disease progression patients begin continuous hormonal treatment similar to arm II
Arm II Patients undergo continuous androgen deprivation without scheduled interruptions Patients receive LHRH analog BSRL ZDX or LEUP with an antiandrogen ANAN FLUT CDX or CPTR OR undergo bilateral orchiectomy within 5 days of randomization and receive an antiandrogen Patients receive LHRH analog by SC or IM implant every 1-4 months beginning within 5 days of randomization and oral antiandrogen 1-3 times daily depending on the actual LHRH analog and antiandrogen PSA levels are monitored every 2 months Treatment continues until hormone resistance develops
Patients receiving LHRH analog may begin antiandrogen therapy either prior to or simultaneously with LHRH analog and must continue antiandrogen therapy for at least 4 weeks to block tumor flare
Quality of life is assessed at randomization every 4 months for 2 years every 8 months until development of hormone resistance at the time of hormone resistance and then annually thereafter
Patients are followed annually for survival
PROJECTED ACCRUAL A total of 1386 patients will be accrued for this study within 7 years
Compare the survival of prostate cancer patients with prostate-specific antigen progression in the clinical absence of distant metastases after prior radical radiotherapy treated with intermittent androgen suppression IAS vs continuous androgen deprivation CAD
Compare the time to the development of hormone resistance in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the serum cholesterol and HDLLDL levels at 3 years with those at baseline and compare them annually in patients treated with these regimens
Evaluate the duration of treatment and non-treatment intervals time to testosterone recovery return to pre-therapy levels and time to recover potency in patients treated with IAS
OUTLINE This is a randomized multicenter study Patients are stratified according to prior radical prostatectomy yes vs no time since completion of prior radical radiotherapy 1 to 3 years vs 3 years or more baseline prostate-specific antigen PSA value 3-15 ngmL vs greater than 15 ngmL and prior hormonal therapy neo-adjuvant concurrent or adjuvant cytoreduction in association with the radical radiotherapy treatment or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization yes vs no Patients are randomized to one of two treatment arms
Arm I Patients undergo intermittent androgen suppression IAS Patients receive luteinizing hormone-releasing hormone LHRH analog buserelin BSRL goserelin ZDX or leuprolide LEUP and an antiandrogen nilutamide ANAN flutamide FLUT bicalutamide CDX or cyproterone acetate CPTR for 8 months Patients receive LHRH analog by subcutaneous SC or intramuscular IM implant every 1-4 months beginning within 5 days of randomization and oral antiandrogen 1-3 times daily depending on the actual LHRH analog and antiandrogen PSA levels are monitored every 2 months If PSA falls to normal during the 8-month treatment period therapy stops until levels rise to 10 ngmL at which time IAS resumes for another 8-month period IAS continues as long as PSA levels are controlled At the time of disease progression patients begin continuous hormonal treatment similar to arm II
Arm II Patients undergo continuous androgen deprivation without scheduled interruptions Patients receive LHRH analog BSRL ZDX or LEUP with an antiandrogen ANAN FLUT CDX or CPTR OR undergo bilateral orchiectomy within 5 days of randomization and receive an antiandrogen Patients receive LHRH analog by SC or IM implant every 1-4 months beginning within 5 days of randomization and oral antiandrogen 1-3 times daily depending on the actual LHRH analog and antiandrogen PSA levels are monitored every 2 months Treatment continues until hormone resistance develops
Patients receiving LHRH analog may begin antiandrogen therapy either prior to or simultaneously with LHRH analog and must continue antiandrogen therapy for at least 4 weeks to block tumor flare
Quality of life is assessed at randomization every 4 months for 2 years every 8 months until development of hormone resistance at the time of hormone resistance and then annually thereafter
Patients are followed annually for survival
PROJECTED ACCRUAL A total of 1386 patients will be accrued for this study within 7 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000066745 | OTHER | PDQ | None |
| CAN-NCIC-PR7 | OTHER | None | None |
| SWOG-JPR7 | OTHER | None | None |
| ICR-CTSU-JPR7 | OTHER | None | None |