A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel
This trial is active, not recruiting.
|Condition||adenocarcinoma of the prostate|
|Treatments||docetaxel + hormonal treatment (lh-rh agonist), hormonal treatment (lh-rh agonist)|
|Sponsor||Assistance Publique - Hôpitaux de Paris|
|Collaborator||ARTIC group (oncologists and urologists association)|
|Start date||June 2003|
|End date||November 2009|
|Trial size||254 participants|
|Trial identifier||NCT00764166, AOM 03108|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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
Male participants at least 18 years old.
- Histologically documented adenocarcinoma of the prostate
- Previous treatment with either radical prostatectomy or radiation therapy
- Salvage radiotherapy for local relapse allowed
- Neoadjuvant or per radiotherapy Hormonal therapy allowed in case of more than 6 months free-interval before first rising PSA
- Life expectancy of more than 12 months
- Non metastatic disease documented by imaging including radionuclide bone scan
- ECOG performance status 0-1
- ANC > 1,500/mm3
- Platelet counts > 100,000/mm3
- SGOT and/or SGPT may be up to 2.5 x ULN Patients at high risk of biological relapse defined by:
- Gleason > 8
- PSA-DT < 6 months
- Positive surgical margins
- PSA velocity > 0.75 ng/mL/year
- Pathological pelvic lymph nodes involvement (pN+)
- Time from initial treatment until inclusion < 12 months
- Prior chemotherapy by taxanes and estramustine phosphate
- Documented local recurrence of prostate cancer or documented metastatic disease
- History of other malignancy within the last 5 years other than curatively treated basal cell carcinoma of the skin
- Active infection
- Significant cardiac disease, angina pectoris or myocardial infarction within twelve months
- Clinically significant neuropathy
- Medical condition requiring the use of concomitant corticosteroids
- Prohibited concomitant therapy with experimental drug.
- Participation in another clinical trial for the period < 30 days
|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|
|Principal investigator||Stephane Oudard, MD PhD|
|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 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). 1. 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 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 351:1502-1512, 2004|
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