Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430183
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-09
First Post:
2007-01-30
Brief Title:
Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk Clinically Localized Prostate Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
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 Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Androgens can cause the growth of prostate cancer cells Antihormone therapy such as goserelin and leuprolide may stop the adrenal glands from making androgens Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer
PURPOSE This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer
PURPOSE This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer
Detailed Description:
This randomized trial tests whether the addition of chemohormonal therapy improves PSA-progression free survival in patients with high risk clinically-localized prostate cancer The neoadjuvant approach is taken since there appears to be a higher acceptance rate in the prostate population for this type of therapy and several phase II trials have demonstrated its safety Multiple chemotherapeutic therapies have shown efficacy in advanced prostate cancer and docetaxel has become the community standard Many high risk patients are initiated on LHRH agonists at or near the time of diagnosis of their prostate cancer In order to allow the inclusion of these patients in the protocol enhanced enrollment and maintain compliance with therapy up to 3 months of androgen deprivation therapy prior to enrollment will be permitted This study will therefore be able to test the hypothesis that targeting both androgen-sensitive and chemotherapy- sensitive prostate cancer cells will improve outcomes in these high-risk patients
OUTLINE This is a multicenter randomized study Patients are stratified according to nomogram-predicted biochemical progression-free survival at 5 years 0-209 vs 21-399 vs 40-599 vs 60 and androgen-deprivation therapy prior to randomization 4 months no vs yes Patients are randomized to 1 of 2 treatment arms Please see the Arms sections for more details
The primary and secondary objectives are described below
Primary
- To determine whether treatment with neoadjuvant docetaxel and androgen deprivation therapy prior to radical prostatectomy will increase the rate of 3-year biochemical progression-free survival bPFS compared to treatment with immediate radical prostatectomy alone for high-risk prostate cancer patients
Secondary
To compare the 5-year bPFS rate bPFS disease progression disease-free survival and overall survival of patients randomized to the two arms of this trial
To determine the safety and tolerability of neoadjuvant docetaxel and androgen deprivation therapy prior to surgery for high-risk patients undergoing radical prostatectomy
To compare the impact of neoadjuvant docetaxel and androgen deprivation therapy on time to clinically apparent local disease recurrence and metastatic disease in high-risk patients undergoing radical prostatectomy for clinically localized prostate cancer
To compare the impact of neoadjuvant docetaxel and androgen deprivation therapy relative to RP on pathologic tumor stage frequency of lymph node metastases and positive margin rates for high-risk patients undergoing radical prostatectomy for clinically localized prostate cancer
To determine if changes in serum testosterone levels will predict bPFS
To determine prospectively whether PSA doubling time PSADT is a surrogate endpoint for time to clinical metastases and overall survival
Patients are followed up to 15 years post-randomization
OUTLINE This is a multicenter randomized study Patients are stratified according to nomogram-predicted biochemical progression-free survival at 5 years 0-209 vs 21-399 vs 40-599 vs 60 and androgen-deprivation therapy prior to randomization 4 months no vs yes Patients are randomized to 1 of 2 treatment arms Please see the Arms sections for more details
The primary and secondary objectives are described below
Primary
- To determine whether treatment with neoadjuvant docetaxel and androgen deprivation therapy prior to radical prostatectomy will increase the rate of 3-year biochemical progression-free survival bPFS compared to treatment with immediate radical prostatectomy alone for high-risk prostate cancer patients
Secondary
To compare the 5-year bPFS rate bPFS disease progression disease-free survival and overall survival of patients randomized to the two arms of this trial
To determine the safety and tolerability of neoadjuvant docetaxel and androgen deprivation therapy prior to surgery for high-risk patients undergoing radical prostatectomy
To compare the impact of neoadjuvant docetaxel and androgen deprivation therapy on time to clinically apparent local disease recurrence and metastatic disease in high-risk patients undergoing radical prostatectomy for clinically localized prostate cancer
To compare the impact of neoadjuvant docetaxel and androgen deprivation therapy relative to RP on pathologic tumor stage frequency of lymph node metastases and positive margin rates for high-risk patients undergoing radical prostatectomy for clinically localized prostate cancer
To determine if changes in serum testosterone levels will predict bPFS
To determine prospectively whether PSA doubling time PSADT is a surrogate endpoint for time to clinical metastases and overall survival
Patients are followed up to 15 years post-randomization
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 |
|---|---|---|---|
| CDR0000526353 | OTHER | Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |