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 : August 31, 2018
|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 :||June 2019|
|Estimated Study Completion Date :||September 2019|
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 ]
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): NCT02772562
|Contact: Mike Wheelerfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Michael Lilly, MD||Medical University of South Carolina|