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

June 14, 2023 updated by: Candel Therapeutics, Inc.

A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán
  • United States
    • Colorado
      • Golden, Colorado, United States, 80401
        • Foothills Urology
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Southeast Louisiana Veterans Health Care System
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Nevada Health Care System VA
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • North Hills, New York, United States, 11042
        • Advanced Radiation Centers of New York (Integrated Medical Professionals)
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals of NY, PLLC
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Southwest Urology, Clinical Research Solutions
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma City VA Healthcare System
    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System
      • Springfield, Oregon, United States, 97477
        • Oregon Urology Insitute
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster Urology
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Health Network-Triangle Urological Group
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Ralph H. Johnson Veterans Affairs Medical Center
    • Texas
      • San Antonio, Texas, United States, 78229-4404
        • San Antonio VA Healthcare System
      • The Woodlands, Texas, United States, 77384
        • Woodland Center
      • Tomball, Texas, United States, 77375
        • Texas Urology Specialists
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire VA Medical Center
      • Salem, Virginia, United States, 24153
        • Salem VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria include:

  • 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 include:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
Drug: valacyclovir
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.
Biological: placebo
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.
Active Comparator: CAN-2409
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
Biological: aglatimagene besadenovec
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.
Other Names:
  • CAN-2409
  • AdV-tk
Drug: valacyclovir
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Baseline to study completion, approximately 5 years
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 Outcome Measures

Outcome Measure
Time Frame
Negative biopsy rate at 1-year landmark
Time Frame: 1 year
1 year
Percentage of patients with adverse events
Time Frame: 30 days after last dose of study drug
30 days after last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Candel Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimated)

May 11, 2016

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PrTK04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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