A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer (Prospect)
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|ClinicalTrials.gov Identifier: NCT01322490|
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : August 8, 2019
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic||Biological: PROSTVAC-V Biological: PROSTVAC-F Drug: GM-CSF Other: GM-CSF Placebo Biological: Placebo||Phase 3|
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:
- (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF
- (Arm V) PROSTVAC-V/F plus GM-CSF placebo
- (Arm P) Double placebo
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1297 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer|
|Actual Study Start Date :||November 28, 2011|
|Actual Primary Completion Date :||September 25, 2017|
|Actual Study Completion Date :||December 15, 2017|
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF placebo
Other: GM-CSF Placebo
Placebo Comparator: Placebo Control
PROSTVAC V/F Placebo + GM-CSF Placebo
Other: GM-CSF Placebo
PROSTVAC V/F Placebo
- Overall Survival [ 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. ]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.
- Number of Subjects Alive Without Event at 6 Months [ Time Frame: Randomization through Week 25/End of Treatment visit. ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322490
|Principal Investigator:||James L. Gulley, MD||National Cancer Institute (NCI)|
|Principal Investigator:||Philip Kantoff, MD||Dana-Farber Cancer Institute|