Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00288080
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2006-02-06
Brief Title:
Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Protocol of Androgen Suppression AS and 3DCRTIMRT Vs AS and 3DCTRIMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized High-Risk Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2022-05
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 Hormone therapy using drugs such as leuprolide goserelin flutamide or bicalutamide may fight prostate cancer by lowering the amount of androgens the body makes Radiation therapy uses high-energy x-rays to kill tumor cells Drugs used in chemotherapy such as docetaxel and prednisone work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer
PURPOSE This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer
PURPOSE This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer
Detailed Description:
OBJECTIVES
Primary
Compare the relative efficacy in terms of overall survival of the combination of androgen suppression and radiotherapy versus androgen suppression and radiotherapy followed by docetaxel and prednisone in patients with localized high-risk prostate cancer
Secondary
Compare the disease-free survival and incidence of adverse events in patients treated with these regimens
Compare the biochemical control local control and freedom from distant metastases in patients treated with these regimens
Determine the validity of prostate-specific antigen PSA-defined endpoints as a surrogate for overall survival of patients treated with these regimens
Compare the time interval between biochemical failure and distant metastases with respect to testosterone level in patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to risk group
Arm I Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone LHRH agonist eg leuprolide acetate goserelin buserelin or triptorelin and oral antiandrogen ie oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months Beginning at week 8 patients undergo radiotherapy 5 days a week for approximately 8 weeks Antiandrogen therapy is discontinued at completion of radiotherapy but LHRH agonist therapy continues for 20 months
Arm II Patients receive androgen suppression therapy and undergo radiotherapy as in arm I Beginning 4 weeks after completion of radiotherapy patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients continue LHRH agonist therapy as in arm I
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 600 patients will be accrued for this study
Primary
Compare the relative efficacy in terms of overall survival of the combination of androgen suppression and radiotherapy versus androgen suppression and radiotherapy followed by docetaxel and prednisone in patients with localized high-risk prostate cancer
Secondary
Compare the disease-free survival and incidence of adverse events in patients treated with these regimens
Compare the biochemical control local control and freedom from distant metastases in patients treated with these regimens
Determine the validity of prostate-specific antigen PSA-defined endpoints as a surrogate for overall survival of patients treated with these regimens
Compare the time interval between biochemical failure and distant metastases with respect to testosterone level in patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to risk group
Arm I Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone LHRH agonist eg leuprolide acetate goserelin buserelin or triptorelin and oral antiandrogen ie oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months Beginning at week 8 patients undergo radiotherapy 5 days a week for approximately 8 weeks Antiandrogen therapy is discontinued at completion of radiotherapy but LHRH agonist therapy continues for 20 months
Arm II Patients receive androgen suppression therapy and undergo radiotherapy as in arm I Beginning 4 weeks after completion of radiotherapy patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients continue LHRH agonist therapy as in arm I
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 600 patients will be accrued for this study
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-2009-00728 | REGISTRY | CTRP Clinical Trial Reporting Program | None |
| CDR0000462375 | None | None | None |