Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
Public ClinicalTrials.gov record NCT02768363. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02768363
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 187 participants
Conditions and interventions
Conditions
Interventions
- aglatimagene besadenovec Biological
- placebo Biological
- valacyclovir Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2016
- Primary completion
- Oct 31, 2024
- Completion
- Nov 30, 2026
- Last update posted
- Jul 29, 2025
2016 – 2026
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Foothills Urology | Golden | Colorado | 80401 | — |
| Jesse Brown VA Medical Center | Chicago | Illinois | 60612 | — |
| The University of Chicago | Chicago | Illinois | 60637 | — |
| Southeast Louisiana Veterans Health Care System | New Orleans | Louisiana | 70119 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | — |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | — |
| Sierra Nevada Health Care System VA | Reno | Nevada | 89502 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Advanced Radiation Centers of New York (Integrated Medical Professionals) | North Hills | New York | 11042 | — |
| Associated Medical Professionals of NY, PLLC | Syracuse | New York | 13210 | — |
| Southwest Urology, Clinical Research Solutions | Middleburg Heights | Ohio | 44130 | — |
| Oklahoma City VA Healthcare System | Oklahoma City | Oklahoma | 73104 | — |
| VA Portland Health Care System | Portland | Oregon | 97239 | — |
| Oregon Urology Insitute | Springfield | Oregon | 97477 | — |
| Lancaster Urology | Lancaster | Pennsylvania | 17604 | — |
| Allegheny Health Network-Triangle Urological Group | Pittsburgh | Pennsylvania | 15212 | — |
| Ralph H. Johnson Veterans Affairs Medical Center | Charleston | South Carolina | 29401 | — |
| San Antonio VA Healthcare System | San Antonio | Texas | 78229-4404 | — |
| Woodland Center | The Woodlands | Texas | 77384 | — |
| Texas Urology Specialists | Tomball | Texas | 77375 | — |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | — |
| Salem VA Medical Center | Salem | Virginia | 24153 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02768363, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2025 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02768363 live on ClinicalTrials.gov.