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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02768363
• Other study ID #: PrTK04
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 2016

Study information

• Verified date: June 2024
• Source: Candel Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 187
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Drug:
• valacyclovir
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán	Mexico City
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Ralph H. Johnson Veterans Affairs Medical Center	Charleston	South Carolina
United States	Jesse Brown VA Medical Center	Chicago	Illinois
United States	The University of Chicago	Chicago	Illinois
United States	Foothills Urology	Golden	Colorado
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	Lancaster Urology	Lancaster	Pennsylvania
United States	Southwest Urology, Clinical Research Solutions	Middleburg Heights	Ohio
United States	Southeast Louisiana Veterans Health Care System	New Orleans	Louisiana
United States	Advanced Radiation Centers of New York (Integrated Medical Professionals)	North Hills	New York
United States	Oklahoma City VA Healthcare System	Oklahoma City	Oklahoma
United States	Allegheny Health Network-Triangle Urological Group	Pittsburgh	Pennsylvania
United States	VA Portland Health Care System	Portland	Oregon
United States	Sierra Nevada Health Care System VA	Reno	Nevada
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	Salem VA Medical Center	Salem	Virginia
United States	San Antonio VA Healthcare System	San Antonio	Texas
United States	Oregon Urology Insitute	Springfield	Oregon
United States	Associated Medical Professionals of NY, PLLC	Syracuse	New York
United States	Woodland Center	The Woodlands	Texas
United States	Texas Urology Specialists	Tomball	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Candel Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Negative biopsy rate at 1-year landmark		1 year
Secondary	Percentage of patients with adverse events		30 days after last dose of study drug