A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel (RisingPSA)
|ClinicalTrials.gov Identifier: NCT00764166|
Recruitment Status : Unknown
Verified September 2008 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Active, not recruiting
First Posted : October 1, 2008
Last Update Posted : October 1, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate||Drug: Docetaxel + hormonal treatment (LH-RH agonist) Drug: Hormonal treatment (LH-RH agonist)||Phase 3|
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 underway.•53% 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 years.A 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).
- PETRYLAK DP, et al: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513-1520, 2004
- TANNOCK IF, de Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||254 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2003|
|Estimated Primary Completion Date :||November 2009|
|Estimated Study Completion Date :||November 2010|
Drug: Docetaxel + hormonal treatment (LH-RH agonist)
Docetaxel will be administered:
Triptorelin was given by injection for 4 times every 3 months Bicalutamide was given at the same time with LH-RH agonist for 3 weeks ; taken orally
|Active Comparator: 2||
Drug: Hormonal treatment (LH-RH agonist)
Triptorelin was given by injection for 4 times every 3 months. Bicalutamide given at the same time with LH-RH agonist for 3 weeks ; taken orally.
- The primary endpoint was 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). [ Time Frame: Every month during 5 years. ]
- Secondary endpoints were metastasis-free survival, PSA response (decrease > 50 % of the PSA), overall survival, cancer specific survival, safety and quality of life (QoL). [ Time Frame: Every month during 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764166
|Service Oncologie Médicale, Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Principal Investigator:||Stephane Oudard, MD PhD||European Georges Pompidou Hospital|