Clinical trial NCT02768363: Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
Official title: A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Immunotherapy
Tumor vaccine
Immuno-oncology
Cytotoxicity
Prostate cancer
Active Surveillance
Lead sponsor: Candel Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 187
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Baseline to study completion, approximately 5 years
Secondary outcomes:
measure: Negative biopsy rate at 1-year landmark
timeFrame: 1 year
measure: Percentage of patients with adverse events
timeFrame: 30 days after last dose of study drug
Other outcomes:
Locations:
city: Golden
country: United States
facility: Foothills Urology
state: Colorado
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System
state: Louisiana
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Reno
country: United States
facility: Sierra Nevada Health Care System VA
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: North Hills
country: United States
facility: Advanced Radiation Centers of New York (Integrated Medical Professionals)
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY, PLLC
state: New York
city: Middleburg Heights
country: United States
facility: Southwest Urology, Clinical Research Solutions
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City VA Healthcare System
state: Oklahoma
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
city: Springfield
country: United States
facility: Oregon Urology Insitute
state: Oregon
city: Lancaster
country: United States
facility: Lancaster Urology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network-Triangle Urological Group
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H. Johnson Veterans Affairs Medical Center
state: South Carolina
city: San Antonio
country: United States
facility: San Antonio VA Healthcare System
state: Texas
city: The Woodlands
country: United States
facility: Woodland Center
state: Texas
city: Tomball
country: United States
facility: Texas Urology Specialists
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: Salem
country: United States
facility: Salem VA Medical Center
state: Virginia
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán
Study officials:
References: