711
Participants
Start Date
September 30, 2011
Primary Completion Date
August 31, 2024
Study Completion Date
December 31, 2030
Aglatimagene besadenovec + valacyclovir
"Patients will receive three courses of ProstAtak® each consisting of aglatimagene besadenovec injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows:~1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation.~2. The second injection will be 0-3 days before initiation of radiation therapy.~3. The third injection will be 15-22 days after the 2nd injection.~The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each AdV-tk injection.~Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification."
Placebo + valacyclovir
"Patients will receive three courses each consisting of placebo injection + oral valacyclovir. Placebo injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows:~1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation.~2. The second injection will be 0-3 days before initiation of radiation therapy.~3. The third injection will be 15-22 days after the 2nd injection.~The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each placebo injection.~Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification."
James J. Peters VA Medical Center, The Bronx
Advanced Radiation Centers of New York (Integrated Medical Professionals), North Hills
Associated Medical Professionals of NY, PLLC, Syracuse
MidLantic Urology, Bala-Cynwyd
Sibley Memorial Hospital, Washington D.C.
Walter Reed National Military Medical Center, Bethesda
VA Maryland Health Care System, Baltimore
Chesapeake Urology Research Associates, Baltimore
The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center, Baltimore
Potomac Urology Center, Alexandria
Hunter Holmes McGuire VA Medical Center, Richmond
Urology of Virginia, PLLC, Virginia Beach
Salem VA Medical Center, Salem
Durham VA Health Care System, Durham
Ralph H. Johnson Veterans Affairs Medical Center, Charleston
Carolina Urologic Research Center, LLC, Myrtle Beach
Clinical Research Center of Florida, Pompano Beach
21st Century Oncology, Fort Lauderdale
21st Century Oncology, Plantation
James A. Haley Veteran's Hospital, Tampa
Florida Urology Partners, Tampa
21st Century Oncology, Naples
21st Century Oncology, Lakewood Rch
Cincinnati VA Medical Center, Cincinnati
Silver Cross Hospital, New Lenox
Jesse Brown VA Medical Center, Chicago
The University of Chicago, Chicago
Kansas City VA Medical Center, Kansas City
Adult & Pediatric Urology, P.C., Omaha
Southeast Louisiana Veterans Health Care System, New Orleans
VA North Texas Health Care System, Dallas
Urology Clinics of North Texas, Dallas
Dr. Irving Fishman's Office, Houston
Houston Willowbrook Radiation Oncology, Houston
Dr. Ned Stein's Office, Houston
Texas Urology Specialists, Tomball
Texas Urology Specialists-The Woodlands, The Woodlands
The Methodist Hospital - The Woodlands, The Woodlands
The University of Texas Health Science Center at San Antonio, San Antonio
Urology Austin, Austin
Austin Urology Institute, Austin
Austin Urology Institute - Northwest Austin Cancer Center, Austin
Advanced Urology, Parker
Colorado Clinical Research, Lakewood
Valley View Hospital, Glenwood Springs
Arizona Center for Cancer Care - Deer Valley, Phoenix
Arizona Center for Cancer Care - Osborne, Scottsdale
Arizona Center for Cancer Care - Shea, Scottsdale
Arizona Oncology Services Foundation, Multiple Locations
Arizona Center for Cancer Care - Gilbert, Gilbert
Arizona Urology Specialists, Glendale
Arizona Center for Cancer Care - Surprise, Surprise
Arizona Center for Cancer Care - Peoria, Peoria
Southern Arizona VA Health Care System, Tucson
New Mexico Oncology Hematology Consultants (NMOHC), Albuquerque
University of New Mexico Cancer Center, Albuquerque
Sheldon Freedman MD, Ltd., Las Vegas
VA Sierra Nevada Health Care System, Reno
Precision Radiation Oncology, Tustin
VA Northern California Health Care System, Mather
VA Portland Health Care System, Portland
Oregon Urology Institute, Springfield
MultiCare Regional Cancer Center - Gig Harbor, Gig Harbor
MultiCare Regional Cancer Center - Tacoma, Tacoma
University of Massachusetts Medical School, Worcester
New Jersey Urology - Cherry Hill, Cherry Hill
New Jersey Urology - Englewood, Englewood
New Jersey Urology - Milburn, Millburn
New Jersey Urology - Saddle Brook, Saddle Brook
New Jersey Urology - West Orange, West Orange
Fox Chase Cancer Center, Philadelphia
South Texas San Antonio VA Healthcare System, San Antonio
VA Caribbean Healthcare System, San Juan
Lead Sponsor
Candel Therapeutics, Inc.
INDUSTRY