Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy
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|ClinicalTrials.gov Identifier: NCT02772562|
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : July 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Biological: PROSTVAC-V/F||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 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|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||February 2020|
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
|Contact: Mike Wheeleremail@example.com|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Michael Lilly, MD 843-792-4271|
|Contact: Mike Wheeler 843-792-9321 firstname.lastname@example.org|
|Principal Investigator:||Michael Lilly, MD||Medical University of South Carolina|