Adenocarcinoma of the Prostate
Conditions
Keywords
PSA (biochemical), Progression- free Survival, Clinical progress, Overall survival, Tolerance to the treatment, Quality of Live
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.
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 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
Interventions
DRUGDocetaxel + hormonal treatment (LH-RH agonist)
Docetaxel will be administered: * To D1 of every cycle in the dose of 70 mg/m², * Perfusion IV of 60 minutes diluted in 250 ml with physiological serum or with serum glucoside from a peripheral or central vein, Every 3 weeks during 6 cycles (except when unacceptable tolerance). 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
DRUGHormonal 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.
Sponsors
ARTIC group (oncologists and urologists association)
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | Every month during 5 years. |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints were metastasis-free survival, PSA response (decrease > 50 % of the PSA), overall survival, cancer specific survival, safety and quality of life (QoL). | Every month during 5 years |
Countries
France
Outcome results
None listed