Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer
1 other identifier
interventional
187
2 countries
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started May 2016
Longer than P75 for phase_2 prostate-cancer
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 6, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJuly 30, 2025
July 1, 2025
8.5 years
May 6, 2016
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline to study completion, approximately 5 years
Secondary Outcomes (2)
Negative biopsy rate at 1-year landmark
1 year
Percentage of patients with adverse events
30 days after last dose of study drug
Study Arms (2)
CAN-2409
ACTIVE COMPARATORPatients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
Placebo
PLACEBO COMPARATORPatients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of the prostate
- Patients choosing active surveillance
- Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature
- NCCN Low Risk is defined as having all of the following: PSA \< 10 ng/ml, Gleason ≤ 6, T1-T2a
- NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
- High Risk with a single high risk feature is defined as having only one of the following: PSA\>20 ng/ml, Gleason score 8-10, or T3a
- Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
- Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.
- ECOG Performance status 0-2
You may not qualify if:
- Active liver disease, including known cirrhosis or active hepatitis
- Patients on systemic corticosteroids (\>10 mg prednisone per day) or other immunosuppressive drugs
- Known HIV+ patients
- Regional lymph node involvement or distant metastases
- Other current malignancy (except squamous or basal cell skin cancers)
- Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up
- Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator
- Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)
- Patients who had or plan to use ADT or have history of an orchiectomy.
- Patients who are planning to undergo radical treatment for prostate cancer within 12 months.
- Known sensitivity or allergic reactions to acyclovir or valacyclovir
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Foothills Urology
Golden, Colorado, 80401, United States
Jesse Brown VA Medical Center
Chicago, Illinois, 60612, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, 70119, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Sierra Nevada Health Care System VA
Reno, Nevada, 89502, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Advanced Radiation Centers of New York (Integrated Medical Professionals)
North Hills, New York, 11042, United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 13210, United States
Southwest Urology, Clinical Research Solutions
Middleburg Heights, Ohio, 44130, United States
Oklahoma City VA Healthcare System
Oklahoma City, Oklahoma, 73104, United States
VA Portland Health Care System
Portland, Oregon, 97239, United States
Oregon Urology Insitute
Springfield, Oregon, 97477, United States
Lancaster Urology
Lancaster, Pennsylvania, 17604, United States
Allegheny Health Network-Triangle Urological Group
Pittsburgh, Pennsylvania, 15212, United States
Ralph H. Johnson Veterans Affairs Medical Center
Charleston, South Carolina, 29401, United States
San Antonio VA Healthcare System
San Antonio, Texas, 78229-4404, United States
Woodland Center
The Woodlands, Texas, 77384, United States
Texas Urology Specialists
Tomball, Texas, 77375, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Salem VA Medical Center
Salem, Virginia, 24153, United States
Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán
Mexico City, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2016
First Posted
May 11, 2016
Study Start
May 1, 2016
Primary Completion
November 1, 2024
Study Completion (Estimated)
December 1, 2026
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share