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Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
Sponsor: Candel Therapeutics, Inc.
Summary
The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.
Official title: A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
711
Start Date
2011-09
Completion Date
2030-12
Last Updated
2025-07-30
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (73)
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, United States
Arizona Urology Specialists
Glendale, Arizona, United States
Arizona Oncology Services Foundation
Multiple Locations, Arizona, United States
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, United States
Arizona Center for Cancer Care - Deer Valley
Phoenix, Arizona, United States
Arizona Center for Cancer Care - Osborne
Scottsdale, Arizona, United States
Arizona Center for Cancer Care - Shea
Scottsdale, Arizona, United States
Arizona Center for Cancer Care - Surprise
Surprise, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
VA Northern California Health Care System
Mather, California, United States
Precision Radiation Oncology
Tustin, California, United States
Valley View Hospital
Glenwood Springs, Colorado, United States
Colorado Clinical Research
Lakewood, Colorado, United States
Advanced Urology
Parker, Colorado, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
21st Century Oncology
Fort Lauderdale, Florida, United States
21st Century Oncology
Lakewood Rch, Florida, United States
21st Century Oncology
Naples, Florida, United States
21st Century Oncology
Plantation, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
James A. Haley Veteran's Hospital
Tampa, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
Jesse Brown VA Medical Center
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
Silver Cross Hospital
New Lenox, Illinois, United States
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, United States
VA Maryland Health Care System
Baltimore, Maryland, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Adult & Pediatric Urology, P.C.
Omaha, Nebraska, United States
Sheldon Freedman MD, Ltd.
Las Vegas, Nevada, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
New Jersey Urology - Cherry Hill
Cherry Hill, New Jersey, United States
New Jersey Urology - Englewood
Englewood, New Jersey, United States
New Jersey Urology - Milburn
Millburn, New Jersey, United States
New Jersey Urology - Saddle Brook
Saddle Brook, New Jersey, United States
New Jersey Urology - West Orange
West Orange, New Jersey, United States
New Mexico Oncology Hematology Consultants (NMOHC)
Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Advanced Radiation Centers of New York (Integrated Medical Professionals)
North Hills, New York, United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, United States
James J. Peters VA Medical Center
The Bronx, New York, United States
Durham VA Health Care System
Durham, North Carolina, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, United States
VA Portland Health Care System
Portland, Oregon, United States
Oregon Urology Institute
Springfield, Oregon, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Ralph H. Johnson Veterans Affairs Medical Center
Charleston, South Carolina, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
Urology Austin
Austin, Texas, United States
Austin Urology Institute
Austin, Texas, United States
Austin Urology Institute - Northwest Austin Cancer Center
Austin, Texas, United States
VA North Texas Health Care System
Dallas, Texas, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Dr. Irving Fishman's Office
Houston, Texas, United States
Houston Willowbrook Radiation Oncology
Houston, Texas, United States
Dr. Ned Stein's Office
Houston, Texas, United States
South Texas San Antonio VA Healthcare System
San Antonio, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Texas Urology Specialists-The Woodlands
The Woodlands, Texas, United States
The Methodist Hospital - The Woodlands
The Woodlands, Texas, United States
Texas Urology Specialists
Tomball, Texas, United States
Potomac Urology Center
Alexandria, Virginia, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Salem VA Medical Center
Salem, Virginia, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States
MultiCare Regional Cancer Center - Gig Harbor
Gig Harbor, Washington, United States
MultiCare Regional Cancer Center - Tacoma
Tacoma, Washington, United States
VA Caribbean Healthcare System
San Juan, Puerto Rico