The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and PROSTVAC without GM-CSF versus controls. Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are: 1. (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF 2. (Arm V) PROSTVAC-V/F plus GM-CSF placebo 3. (Arm P) Double placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,297
Overall Survival
The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.
Time frame: Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study.
Number of Subjects Alive Without Event at 6 Months
A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such. Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death.
Time frame: Randomization through Week 25/End of Treatment visit.
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PROSTVAC V/F Placebo
Alaska Clinical Research Center, Llc
Anchorage, Alaska, United States
Scottsdale Healthcare
Scottsdale, Arizona, United States
Alta Bates Summit Medical Center
Berkeley, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Prostate Oncology Specialists, Inc.
Marina del Rey, California, United States
Desert Hematology-Oncology
Rancho Mirage, California, United States
San Bernardino Urological Associates
San Bernardino, California, United States
San Diego Clinical Trials
San Diego, California, United States
Sharp Memorial Hospital
San Diego, California, United States
VA San Diego Healthcare System
San Diego, California, United States
...and 210 more locations