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

Phase 3

• Conditions: Adenocarcinoma of the Prostate
• Interventions: Drug: Docetaxel + hormonal treatment (LH-RH agonist); Drug: Hormonal treatment (LH-RH agonist)

• Registration Number: NCT00764166
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2003-06
• Status Verified: 2008-09
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Last Update Submitted: 2008-09-30
• Study First Posted: 2008-10-01
• Last Update Posted: 2008-10-01
• Primary Completion: 2009-11
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 254

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Docetaxel + hormonal treatment (LH-RH agonist)	-
2	Hormonal treatment (LH-RH agonist)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service Oncologie Médicale, Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France