Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110162
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2005-05-03
Brief Title:
Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
Sponsor:
Peter MacCallum Cancer Centre Australia
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Collaborative Randomized Phase III Trial The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
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 Androgen deprivation therapy may stop the adrenal glands from making androgens
PURPOSE This randomized phase III trial is studying how well androgen deprivation therapy works in treating patients with prostate cancer
PURPOSE This randomized phase III trial is studying how well androgen deprivation therapy works in treating patients with prostate cancer
Detailed Description:
OBJECTIVES
Primary
Compare overall survival with acceptable morbidity of patients with prostate cancer treated with delayed vs immediate androgen deprivation therapy ADT
Secondary
Compare cancer-specific survival of patients treated with these regimens
Compare clinical progression in patients treated with these regimens
Compare time to first androgen independence in patients treated with these regimens
Compare complication rate incidence and timing eg cord compression or pathological failure in patients treated with these regimens
Compare treatment-related morbidity including cognitive morbidity or osteoporosis in patients treated with these regimens
Compare quality of life of patients treated with these regimens
Determine prognostic factors for progression in patients treated with delayed ADT
OUTLINE This is a multicenter randomized controlled study Patients in group 1 are stratified according to prior therapy prostatectomy vs radiotherapy vs prostatectomy and radiotherapy relapse-free interval 2 years vs 2 years type of planned androgen deprivation therapy ADT continuous vs intermittent and participating center Patients in group 2 are stratified according to type of planned ADT continuous vs intermittent disease type localized vs metastatic and participating center Patients in both groups are randomized to 1 of 2 treatment arms
Arm I delayed ADT Beginning at least 2 years after study entry or after exhibiting evidence of significant disease progression patients receive either continuous ADT OR intermittent ADT comprising either bilateral orchiectomy OR luteinizing hormone-releasing hormone agonist with or without oral antiandrogen therapy
Arm II immediate ADT Beginning immediately after randomization patients receive either continuous ADT OR intermittent ADT as in arm I
NOTE Patients in group 1 begin delayed ADT at least 2 years after study entry unless 1 of the following clinical criteria is present prostate-specific antigen PSA doubling time of 12 months with PSA 10 ngmL OR PSA doubling time of 6 months based on 3 consecutive measurements obtained 2 months apart OR development of metastases or symptoms Patients in group 2 begin delayed ADT at least 2 years after study entry unless 1 of the following clinical criteria is present development of symptoms OR PSA 60 ngmL OR PSA doubling time of 6 months based on 3 consecutive measurements obtained 2 months apart
After 9 months of ADT all patients are assessed for response Patients with PSA 4 ngmL may discontinue ADT These patients are followed every 3 months Treatment may be restarted when PSA is 20 ngmL OR PSA is the PSA level at study entry OR at clinical progression
Quality of life is assessed at baseline every 6 months for 2 years and then annually for 3 years
Patients are followed every 3 months for 2 years every 6 months for 3 years and then periodically thereafter at the discretion of the principal investigator
PROJECTED ACCRUAL A total of 300-2000 patients will be accrued for this study within 2-5 years
Primary
Compare overall survival with acceptable morbidity of patients with prostate cancer treated with delayed vs immediate androgen deprivation therapy ADT
Secondary
Compare cancer-specific survival of patients treated with these regimens
Compare clinical progression in patients treated with these regimens
Compare time to first androgen independence in patients treated with these regimens
Compare complication rate incidence and timing eg cord compression or pathological failure in patients treated with these regimens
Compare treatment-related morbidity including cognitive morbidity or osteoporosis in patients treated with these regimens
Compare quality of life of patients treated with these regimens
Determine prognostic factors for progression in patients treated with delayed ADT
OUTLINE This is a multicenter randomized controlled study Patients in group 1 are stratified according to prior therapy prostatectomy vs radiotherapy vs prostatectomy and radiotherapy relapse-free interval 2 years vs 2 years type of planned androgen deprivation therapy ADT continuous vs intermittent and participating center Patients in group 2 are stratified according to type of planned ADT continuous vs intermittent disease type localized vs metastatic and participating center Patients in both groups are randomized to 1 of 2 treatment arms
Arm I delayed ADT Beginning at least 2 years after study entry or after exhibiting evidence of significant disease progression patients receive either continuous ADT OR intermittent ADT comprising either bilateral orchiectomy OR luteinizing hormone-releasing hormone agonist with or without oral antiandrogen therapy
Arm II immediate ADT Beginning immediately after randomization patients receive either continuous ADT OR intermittent ADT as in arm I
NOTE Patients in group 1 begin delayed ADT at least 2 years after study entry unless 1 of the following clinical criteria is present prostate-specific antigen PSA doubling time of 12 months with PSA 10 ngmL OR PSA doubling time of 6 months based on 3 consecutive measurements obtained 2 months apart OR development of metastases or symptoms Patients in group 2 begin delayed ADT at least 2 years after study entry unless 1 of the following clinical criteria is present development of symptoms OR PSA 60 ngmL OR PSA doubling time of 6 months based on 3 consecutive measurements obtained 2 months apart
After 9 months of ADT all patients are assessed for response Patients with PSA 4 ngmL may discontinue ADT These patients are followed every 3 months Treatment may be restarted when PSA is 20 ngmL OR PSA is the PSA level at study entry OR at clinical progression
Quality of life is assessed at baseline every 6 months for 2 years and then annually for 3 years
Patients are followed every 3 months for 2 years every 6 months for 3 years and then periodically thereafter at the discretion of the principal investigator
PROJECTED ACCRUAL A total of 300-2000 patients will be accrued for this study within 2-5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PMCC-TROG-0306 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000413706 | REGISTRY | None | None |