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Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
Sponsor: Candel Therapeutics, Inc.
Summary
The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. CAN-2409 has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that CAN-2409 can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the CAN-2409 or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.
Official title: A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
187
Start Date
2016-05
Completion Date
2026-12
Last Updated
2025-07-30
Healthy Volunteers
No
Conditions
Interventions
aglatimagene besadenovec
Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
placebo
Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
valacyclovir
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.
Locations (23)
Foothills Urology
Golden, Colorado, United States
Jesse Brown VA Medical Center
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Sierra Nevada Health Care System VA
Reno, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, 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
Southwest Urology, Clinical Research Solutions
Middleburg Heights, Ohio, United States
Oklahoma City VA Healthcare System
Oklahoma City, Oklahoma, United States
VA Portland Health Care System
Portland, Oregon, United States
Oregon Urology Insitute
Springfield, Oregon, United States
Lancaster Urology
Lancaster, Pennsylvania, United States
Allegheny Health Network-Triangle Urological Group
Pittsburgh, Pennsylvania, United States
Ralph H. Johnson Veterans Affairs Medical Center
Charleston, South Carolina, United States
San Antonio VA Healthcare System
San Antonio, Texas, United States
Woodland Center
The Woodlands, Texas, United States
Texas Urology Specialists
Tomball, Texas, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Salem VA Medical Center
Salem, Virginia, United States
Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán
Mexico City, Mexico