Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT02768363
- Run by
- Candel Therapeutics, Inc.
- People needed
- 187
- Starts
- 2016-05-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-07-30
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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