Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES) (NCT02768363)
A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Foothills Urology — Golden, Colorado
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- Foothills Urology — Golden, Colorado
- Jesse Brown VA Medical Center — Chicago, Illinois
- The University of Chicago — Chicago, Illinois
- Southeast Louisiana Veterans Health Care System — New Orleans, Louisiana
- Walter Reed National Military Medical Center — Bethesda, Maryland
- Kansas City VA Medical Center — Kansas City, Missouri
- Sierra Nevada Health Care System VA — Reno, Nevada
- Hackensack University Medical Center — Hackensack, New Jersey
- Advanced Radiation Centers of New York (Integrated Medical Professionals) — North Hills, New York
- Associated Medical Professionals of NY, PLLC — Syracuse, New York
- Southwest Urology, Clinical Research Solutions — Middleburg Heights, Ohio
- Oklahoma City VA Healthcare System — Oklahoma City, Oklahoma
- VA Portland Health Care System — Portland, Oregon
- Oregon Urology Insitute — Springfield, Oregon
- Lancaster Urology — Lancaster, Pennsylvania
- Allegheny Health Network-Triangle Urological Group — Pittsburgh, Pennsylvania
- Ralph H. Johnson Veterans Affairs Medical Center — Charleston, South Carolina
- San Antonio VA Healthcare System — San Antonio, Texas
- Woodland Center — The Woodlands, Texas
- Texas Urology Specialists — Tomball, Texas
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia
- Salem VA Medical Center — Salem, Virginia
- Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán — Mexico City,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.