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Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT02768363•Candel Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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.
+1 more criteria

Locations (23)

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

Key Dates

Start Date

May 1, 2016

Primary Completion Date

November 1, 2024

Completion Date

December 1, 2026

Last Updated

July 30, 2025

Enrollment

187

ACTUAL participants

Conditions

Prostate Cancer

Interventions

aglatimagene besadenovec

BIOLOGICAL

placebo

BIOLOGICAL

valacyclovir

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC