A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation with Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects with a Rising PSA Following Definitive Local Therapy

• Conditions: Clinically asymptomatic prostate cancer subject with a rising PSA following definitive local therapy; MedDRA version: 9.1Level: LLTClassification code 10060862Term: Prostate cancer

• Registration Number: EUCTR2007-000323-17-FI
• Lead Sponsor: sanofi-aventis US

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-03
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 412

Inclusion Criteria

1.Diagnosis of prostate adenocarcinoma pathologically confirmed.
2.History of radical prostatectomy
3.Demonstration of biochemical progression of disease based on PSA doubling time. The minimum PSA value for eligibility will be greater than or equal to 1. PSA doubling time over three values must be = 9 months with a minimum of 3 weeks between assessments. PSA doubling time calculation must start at a minimum value of 0.2 (see Section 13.2). Subjects in this group may have no radiographic findings that are suspicious for metastatic disease.
4.Serum testosterone ?100 ng/dl.
5.Karnofsky performance status (KPS) ?70%.
6.Adequate organ function as defined by the following laboratory criteria:
WBC = 3500/mm3
ANC = 1500/mm3
Platelet count = 100,000/mm3
Hemoglobin= 10.0 g/dl
Total Bilirubin = ULN unless due to Gilbert’s disease
Creatinine=1.5 mg/dl or creatinine clearance of = 60 cc/min
AST and ALT and Alkaline Phosphatase must be within the range as indicated in the protocol
7.Previous hormonal therapy is allowed provided that the total duration of therapy does not exceed 6 months.
8.Male subjects must be at least 18 years of age.
9.Subjects must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.
10.Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
11.Subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

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

1.Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
2.Uncontrolled serious active infection.
3.Anticipated duration of life of less than 2 years
4.Less than 5-year history of successful treatment for other cancers or concurrent active nonprostate cancer other than nonmelanoma skin tumor.
5.Peripheral neuropathy =Grade 2.
6.History of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80, leuprolide, or bicalutamide.
7.Prior chemotherapy; concurrent treatment on another clinical trial or with any other cancer therapy including chemotherapy, immunotherapy, radiotherapy (except salvage radiation therapy), chemoembolization therapy, cryotherapy.
8.Other severe acute or chronic medical conditions including psychiatric disease(s), or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject’s safety, delay or prohibit protocol participation, or interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
9.Radiographic findings suspicious for metastatic disease in the treating physician’s clinical judgment.
10.Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
11.Subject unlikely to comply with protocol or research tests, eg, uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
12. Subject who participated in another clinical study/ received investigational product within 30 days of screening.

Study & Design

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