A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel

Assistance Publique - Hôpitaux de Paris254 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

254

Conditions

Adenocarcinoma of the Prostate

Interventions

Docetaxel + hormonal treatment (LH-RH agonist)DRUG

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

Hormonal treatment (LH-RH agonist)DRUG

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service Oncologie Médicale, Hopital Europeen Georges Pompidou

Paris, France

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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