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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
187
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 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.
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.
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
...and 13 more locations
Progression-free survival (PFS)
Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer
Time frame: Baseline to study completion, approximately 5 years
Negative biopsy rate at 1-year landmark
Time frame: 1 year
Percentage of patients with adverse events
Time frame: 30 days after last dose of study drug
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