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

• Status: Unknown status
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: ARTIC group (oncologists and urologists association)
• Treatments: Docetaxel; Prolactin Release-Inhibiting Factors

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