A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- leuprolide acetate) in Combination with TAXOTERE® (docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the Same Therapeutic Options in Patients with Prostate Cancer at High Risk of Relapse After Radical Prostatectomy

• Conditions: Prostate Cancer at High Risk of Relapse After Radical Prostatectomy; MedDRA version: 8Level: PTClassification code 10060862

• Registration Number: EUCTR2004-002203-32-AT
• Lead Sponsor: Sanofi-Synthelabo Groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-07
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 1696

Inclusion Criteria

Patients meeting all of the following criteria will be considered for enrollment into the study:
1-Pathologically confirmed adenocarcinoma of the prostate based on central pathology review. All other variants are excluded
2-Randomization should occur less than 90 days after prostatectomy AND lymphadenectomy. (Instructions for Radical Prostatectomy, Appendix H)
3-A predicted probability of 5-year freedom from progression = 60%, as determined by the postoperative nomogram developed by M. Kattan. This probability will be assessed using data from the prostatectomy specimen central review (Johns Hopkins, USA and Karolinska Institute, Sweden).
4-Bone-scan without evidence of metastasis (within 6 months of randomization)
5-Chest x-ray without evidence of metastasis (within 6 months of randomization)
6-Abdominal CT Scan without evidence of metastasis (within 6 months of randomization)
7-Age =18 years
8-ECOG performance status = 1 (Appendix A)
9-Hematology evaluation within 2 weeks prior to randomization:
a.Neutrophils = 2,000/mm3
b.Hemoglobin = 10 g/dL
c.Platelets = 100,000/mm3
10-Hepatic and renal function evaluation within 2 weeks prior to randomization:
a.Serum creatinine =1.5 × UNL for the institution. If serum creatinine is > 1.5 × UNL, calculated creatinine clearance (should be = 60ml/minute).
b.Total serum bilirubin = UNL for the institution. Patients with Gilbert’s syndrome may be eligible if indirect serum bilirubin levels at the time of randomization and, at least 6 month prior to randomization, confirm this condition (i.e. elevated indirect serum bilirubin).
c.SGOT and/or SGPT = 1.5 × institutional UNL if alkaline phosphatase is = UNL OR
d.alkaline phosphatase < 5 × UNL if SGOT and SGPT are = UNL
11-PSA evaluation within 6 months prior to prostatectomy. However, a 90-day timeframe is recommended
12- Undetectable PSA (defined as = 0.1ng/mL using a standard assay) at least 30 days after radical prostatectomy. Note that randomization should occur within 90 days after radical prostatectomy (see inclusion criterion 2).
13-Serum testosterone = 150 ng/dL within 6 months prior to randomization.
14-Life expectancy = 5 years
15-Signed, written informed consent prior to randomization.
16-Patients must be accessible for treatment and follow-up. Patients randomized in this trial must be treated and followed at the participating center.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients presenting with any of the following will not be included in the study:
1-Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy.
2-Prior radiation therapy.
3-Patients who received, are receiving, or scheduled to receive post-operative radiotherapy.
4-Patients taking alternative therapies for cancer must stop taking these therapies prior to randomization. Alternative therapies are not allowed during the treatment or follow-up portions of the study. This includes (but is not limited to) alternative therapies such as:
a.PC-SPES (all types)
b.5-alpha reductase inhibitors
5-Bisphosphonates are to be stopped prior to randomization and are not allowed during the study.
6-Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (= 20 mg methylprednisolone per day or equivalent).
7-History of a malignancy other than prostate cancer. Exceptions to these criteria include:
a.patients with adequately treated non-melanoma skin cancers, and
b.patients with a history of another malignancy that was curatively treated (including patients with superficial bladder cancer) and who have not had evidence of disease for a minimum of 5 years.
8-Peripheral neuropathy = Grade 2.
9-ECG with significant abnormalities (as determined by the investigator) within 90 days prior to randomization.
10-Psychological, familial, sociological, or geographical conditions, which do not permit treatment and/or medical follow-up, required to comply with the study protocol.
11-Patients who are medically unstable, including but not limited to active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome.
12-Patients with history of hypersensitivity to polysorbate 80.
13-Patients with a known history of viral hepatitis (B, C)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified