Metastatic prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10036909 Term: Prostate cancer metastatic
Conditions
Sponsors
MSD
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patient has histologically confirmed adenocarcinomas of the prostate. 2. Archival pathological material is available for submission to central laboratory. 3. Patient has evidence of metastatic disease at protocol entry or at the time of prior hormonal manipulation, determined radiographically by the presence of at least 2 bone scan lesions consistent with metastases or abdominal/pelvic lymph nodes > 2 cm on longest axial measurement. Solitary or ambiguous bone lesions should be confirmed with plain radiographs or magnetic resonance imaging (MRI). 4. Patient has evidence of disease progression despite castrate levels of testosterone ( 7 ng/ml. 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. Patient has received bicalutamide, flutamide, nilutamide or cyproterone within the past 12 months, except for use of less than 30 days duration during the initiation of LHRH analog therapy. 2. Patient has received prior chemotherapy for metastatic prostate cancer. 3. Patient has previously received rapamycin or rapamycin analogs, including deforolimus, temsirolimus, or everolimus. 4. Patient is receiving corticosteroids administered at doses greater than those used for normal replacement therapy. . 5. Patient is receiving an opioid or narcotic analgesic prescribed for pain due to prostate cancer. 6. In the opinion of the investigator, the patient has pain related to metastatic prostate cancer that warrants the initiation of chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of the combination of deforolimus and bicalutamide compared to placebo and bicalutamide by PSA decline within 12 weeks, a surrogate measurement of overall survival efficacy in prostate cancer therapy trials. To determine the safety and tolerability of deforolimus when combined with bicalutamide. ;Secondary Objective: To determine the efficacy of the combination of deforolimus and bicalutamide compared to placebo and bicalutamide by PSA response rate. To determine the efficacy of the combination of deforolimus and bicalutamide compared to placebo and bicalutamide by progression free survival (PFS) analysis. To determine the efficacy of the combination of deforlimus and bicalutamide compared to placebo and bicalutamide by time to PSA progression. ;Primary end point(s): Efficacy: 30% PSA decline with 12 weeks: defined as a >=30% decline from baseline with the first 12 weeks of study treatment. The decline is determined by the lowest post-baseline PSA value with the first 12 weeks. Safety: Tolerability will be assessed by clinical review of all relevant adverse experiences and monitoring variables related to laboratory measurements, physical examinations, and vital signs. | — |
Countries
Belgium, Denmark, Finland, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed