Clinically asymptomatic prostate cancer subject with a rising PSA following definitive local therapy MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Trade Name: TAXOTERE®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: docetaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Sponsors
sanofi-aventis US
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare the efficacy of androgen deprivation with or without Taxotere as determined by the median progression free survival (PFS) within the period of 18 months of therapy and at least 18 months follow-up. ;Secondary Objective: • To evaluate cancer specific survival • To compare overall survival between the 2 treatment groups • To evaluate patient reported outcomes as measured by 3 different assessments In this study, molecular markers will also be evaluated (including, but not limited to, variable gene expression profiles, genetic changes and quantitative methylation of different genes, protein quantification and quantification of circulating tumor cells) for the potential to correlate with clinical and pathological risk factors and to determine if they predict the treatment outcome of high-risk prostate cancer subjects.;Primary end point(s): Progression-Free Survival (PFS) is the primary efficacy endpoint for this study. The PFS period will be measured as the time from randomization to the date of first documentation of PSA progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurs first. The PSA progression is determined as follows: a) during treatment period: progressive disease that requires treatment discontinuation for safety reasons is a 50% increase over the baseline (on-study), which is confirmed by a second value. Two consecutive increases in PSA must be documented over a previous reference value (baseline). The first increase in PSA should occur a minimum of 1 month from the reference value. This increase in PSA should be confirmed at the next consecutive visit (at least 1 month apart, but not longer than 3-month interval of regularly scheduled visits). It is recognized that PSA fluctuations are such that the confirmatory PSA value might be less than the previous value. In these cases, the patient would still be eligible p | — |
Countries
Belgium, Czech Republic, Finland, Germany, Lithuania
Outcome results
None listed