Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy
|ClinicalTrials.gov Identifier: NCT02772562|
Recruitment Status : Active, not recruiting
First Posted : May 13, 2016
Last Update Posted : January 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Biological: PROSTVAC-V/F||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy|
|Actual Study Start Date :||July 18, 2016|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.
0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.
- Anti-tumor effect of PROSTVAC-V/F [ Time Frame: 2 years ]Anti-tumor effect of PROSTVAC-V/F will be determined by the number of subjects experiencing relapse at the two year follow up visit after prostatectomy.
- Observed relapse free survival (RFS) with the predicted "virtual" RFS of each patient. [ Time Frame: 2 years ]The predicted RFS values will be calculated from each patient's clinicl and pathologic data by a risk adapted algorithm. The observed and predicted RFSs will be presented as Kaplan-Meier plots and comparisons will be done by the longrank test.
- Observed relapse free survival (RFS) with the RFSs of a historical comparison group of MUSC prostatectomy patients. [ Time Frame: 2 years ]
- Associations between RFS values and research specimen [ Time Frame: 2 years ]
- Frequency of adverse events as assessed by CTCAE v. 4 [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772562
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Michael Lilly, MD||Medical University of South Carolina|