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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

187

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

November 30, 2024

Study Completion Date

December 31, 2026

Conditions
Prostate Cancer
Interventions
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.

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.

DRUG

valacyclovir

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

Trial Locations (23)

11042

Advanced Radiation Centers of New York (Integrated Medical Professionals), North Hills

13210

Associated Medical Professionals of NY, PLLC, Syracuse

15212

Allegheny Health Network-Triangle Urological Group, Pittsburgh

17604

Lancaster Urology, Lancaster

20889

Walter Reed National Military Medical Center, Bethesda

23249

Hunter Holmes McGuire VA Medical Center, Richmond

24153

Salem VA Medical Center, Salem

29401

Ralph H. Johnson Veterans Affairs Medical Center, Charleston

44130

Southwest Urology, Clinical Research Solutions, Middleburg Heights

60612

Jesse Brown VA Medical Center, Chicago

60637

The University of Chicago, Chicago

64128

Kansas City VA Medical Center, Kansas City

70119

Southeast Louisiana Veterans Health Care System, New Orleans

73104

Oklahoma City VA Healthcare System, Oklahoma City

77375

Texas Urology Specialists, Tomball

77384

Woodland Center, The Woodlands

80401

Foothills Urology, Golden

89502

Sierra Nevada Health Care System VA, Reno

97239

VA Portland Health Care System, Portland

97477

Oregon Urology Insitute, Springfield

07601

Hackensack University Medical Center, Hackensack

78229-4404

San Antonio VA Healthcare System, San Antonio

Unknown

Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán, Mexico City

Sponsors
All Listed Sponsors
lead

Candel Therapeutics, Inc.

INDUSTRY