Ignite Creation Date:
2024-05-05 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00764166
Status:
UNKNOWN
Last Update Posted:
2008-10-01
First Post:
2008-09-30
Brief Title:
A Prospective Randomized Phase III Study Comparing Hormonal Therapy -Docetaxel
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment A Prospective Randomized Phase III Study Comparing Hormonal Therapy -Docetaxel
Status:
UNKNOWN
Status Verified Date:
2008-09
Last Known Status:
ACTIVE_NOT_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:
RisingPSA
Brief Summary:
The primary objective was to evaluate the PSA biochemical progression-free survival PFS of high-risk metastasis-free PC patients treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy RP or radiotherapy RT
The study was powered at 80 to detect a 25 improvement in biochemical PFS for a total sample size estimated at 252 patients with a two-sided type I error rate of 5 non-parametric methods
The study was powered at 80 to detect a 25 improvement in biochemical PFS for a total sample size estimated at 252 patients with a two-sided type I error rate of 5 non-parametric methods
Detailed Description:
Docetaxel was shown to be active in metastatic hormone-refractory prostate cancer PC in phase III trials 1-2 It is likely to demonstrate a substantial role in the management of early-stage PC patients in the neoadjuvant and adjuvant settings where clinical trials are underway53 of all men who undergo radical prostatectomy will develop prostate-specific antigen PSA elevations in the 10 years following surgery with approximately 77 of these recurrences occurring within the first 2 yearsA prospective multicenter national randomized two-arm phase III study comparing hormonal treatment LH-RH agonist alone with or without docetaxel was designed to evaluate the interest of chemotherapy in non-metastatic prostate cancer patients at high risk of systemic recurrence after initial treatment radical prostatectomy or radiotherapy
1 PETRYLAK DP et al Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer N Engl J Med 3511513-1520 2004
2 TANNOCK IF de Wit R Berry WR et al Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer N Engl J Med 3511502-1512 2004
1 PETRYLAK DP et al Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer N Engl J Med 3511513-1520 2004
2 TANNOCK IF de Wit R Berry WR et al Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer N Engl J Med 3511502-1512 2004
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