Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030654
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2002-02-14
Brief Title:
Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Randomized Study of Patients With High Risk Hormone-Naive Prostate Cancer Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy
Status:
COMPLETED
Status Verified Date:
2017-03
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 Drugs such as luteinizing hormone-releasing hormone agonist flutamide and bicalutamide may stop the adrenal glands from producing androgens Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Combining hormone therapy with chemotherapy may kill more tumor cells It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer
Detailed Description:
OBJECTIVES
Primary
Compare the survival of patients with high-risk hormone-naive prostate cancer treated with androgen blockade with concurrent chemotherapy vs delayed chemotherapy
Secondary
Compare biochemical control in patients treated with these regimens
Determine the toxicity of these regimens in these patients
Compare the time to clinical failure as measured by progression on bone scan or CT scan or a prostate-specific antigen PSA doubling time of 32 weeks in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to prior therapy surgery vs radiotherapy andor brachytherapy vs both original combined Gleason score 6 vs 7 vs 8-10 and prior vaccine therapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive androgen blockade AB comprising a luteinizing-hormone releasing-hormone agonist continuously and oral flutamide or oral bicalutamide once daily for at least 1 month Within 4 weeks of initiation of AB patients begin chemotherapy Patients receive 1 and only 1 of the following chemotherapy regimens
Regimen A Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV on day 3 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen B Patients receive oral estramustine 3 times daily on days 1-5 and paclitaxel IV on days 3 10 17 24 31 and 38 Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen C Patients receive oral ketoconazole 3 times daily on days 1-7 15-21 and 29-35 doxorubicin IV on days 1 15 and 29 vinblastine IV on days 8 22 and 36 and oral estramustine 3 times daily on days 8-14 22-28 and 36-42 Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen D Patients receive oral estramustine 3 times daily on days 1-4 and docetaxel IV over 1 hour on days 3 10 and 17 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen E Patients receive docetaxel IV on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen F Patients receive docetaxel IV on days 1 8 and 15 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen G With approval from the protocol chair patients may receive a regimen that has been demonstrated in a published phase II study to have at least a 50 response rate as measured by PSA decrease from baseline over 2 measurements 28 days apart or a decrease in measurable soft tissue disease by 50 in 2 dimensions
Arm II Patients receive AB as in arm I Patients continue with AB until clinical failure at which time patients receive chemotherapy as in arm I Patients who have a response may continue to receive chemotherapy beyond 4 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1050 patients will be accrued for this study within 4-6 years
Primary
Compare the survival of patients with high-risk hormone-naive prostate cancer treated with androgen blockade with concurrent chemotherapy vs delayed chemotherapy
Secondary
Compare biochemical control in patients treated with these regimens
Determine the toxicity of these regimens in these patients
Compare the time to clinical failure as measured by progression on bone scan or CT scan or a prostate-specific antigen PSA doubling time of 32 weeks in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to prior therapy surgery vs radiotherapy andor brachytherapy vs both original combined Gleason score 6 vs 7 vs 8-10 and prior vaccine therapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive androgen blockade AB comprising a luteinizing-hormone releasing-hormone agonist continuously and oral flutamide or oral bicalutamide once daily for at least 1 month Within 4 weeks of initiation of AB patients begin chemotherapy Patients receive 1 and only 1 of the following chemotherapy regimens
Regimen A Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV on day 3 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen B Patients receive oral estramustine 3 times daily on days 1-5 and paclitaxel IV on days 3 10 17 24 31 and 38 Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen C Patients receive oral ketoconazole 3 times daily on days 1-7 15-21 and 29-35 doxorubicin IV on days 1 15 and 29 vinblastine IV on days 8 22 and 36 and oral estramustine 3 times daily on days 8-14 22-28 and 36-42 Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen D Patients receive oral estramustine 3 times daily on days 1-4 and docetaxel IV over 1 hour on days 3 10 and 17 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen E Patients receive docetaxel IV on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen F Patients receive docetaxel IV on days 1 8 and 15 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Regimen G With approval from the protocol chair patients may receive a regimen that has been demonstrated in a published phase II study to have at least a 50 response rate as measured by PSA decrease from baseline over 2 measurements 28 days apart or a decrease in measurable soft tissue disease by 50 in 2 dimensions
Arm II Patients receive AB as in arm I Patients continue with AB until clinical failure at which time patients receive chemotherapy as in arm I Patients who have a response may continue to receive chemotherapy beyond 4 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1050 patients will be accrued for this study within 4-6 years
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 |
|---|---|---|---|
| SWOG-RTOG-P-0014 | None | None | None |
| CDR0000069186 | None | None | None |
| ECOG-RTOG-P-0014 | None | None | None |
| CALGB-RTOG-P-0014 | None | None | None |