a prospective randomized phase iii study comparing hormonal therapy +/-docetaxel

Conditions: Adenocarcinoma of the Prostate

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.

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

Eligibility criteria:
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

Keywords: psa (biochemical) progression- free survival clinical progress overall survival tolerance to the treatment quality of live