Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer

Phase 3

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Biological: Aglatimagene besadenovec + valacyclovir; Biological: Placebo + valacyclovir

• Registration Number: NCT01436968
• Lead Sponsor: Candel Therapeutics, Inc.

Brief Summary

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 711

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProstAtak®	Aglatimagene besadenovec + valacyclovir	Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT
Control	Placebo + valacyclovir	Placebo + valacyclovir + radiation therapy +/- ADT

Primary Outcome Measures

Name	Time	Method
Disease free survival defined as the time from randomization until the date of the first failure event will be compared for the ProstAtak® arm versus the placebo control arm. The analyses will be based on the intent to treat population.	Assessed at each visit every 6 months through year 5 until event occurs.

Secondary Outcome Measures

Name	Time	Method
Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm.	Assessed at each visit every 6 months through year 5 after which long-term follow up of general health status will continue yearly.
PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm.	Assessed at each visit every 6 months through year 5.
Patient reported Health Related Quality of Life outcomes will be collected using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. The change in QOL over time will be compared for the ProstAtak® arm versus the placebo control arm.	Assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.
The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase (until the completion of radiation). Data on late effects will be collected after radiation completion.	Assessed at each visit and continuously throughout the study.

Trial Locations

Locations (70)

Arizona Center for Cancer Care - Gilbert; 🇺🇸 Gilbert, Arizona, United States

21st Century Oncology; 🇺🇸 Plantation, Florida, United States

VA Maryland Health Care System; 🇺🇸 Baltimore, Maryland, United States

Chesapeake Urology Research Associates; 🇺🇸 Baltimore, Maryland, United States

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States

The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

The Methodist Hospital - The Woodlands; 🇺🇸 The Woodlands, Texas, United States

Sheldon Freedman MD, Ltd.; 🇺🇸 Las Vegas, Nevada, United States

Cincinnati VA Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Advanced Radiation Centers of New York (Integrated Medical Professionals); 🇺🇸 North Hills, New York, United States

MidLantic Urology; 🇺🇸 Bala-Cynwyd, Pennsylvania, United States

VA Northern California Health Care System; 🇺🇸 Mather, California, United States

Precision Radiation Oncology; 🇺🇸 Tustin, California, United States

Jesse Brown VA Medical Center; 🇺🇸 Chicago, Illinois, United States

Silver Cross Hospital; 🇺🇸 New Lenox, Illinois, United States

New Jersey Urology - Milburn; 🇺🇸 Millburn, New Jersey, United States

New Jersey Urology - Saddle Brook; 🇺🇸 Saddle Brook, New Jersey, United States

New Jersey Urology - Cherry Hill; 🇺🇸 Cherry Hill, New Jersey, United States

New Mexico Oncology Hematology Consultants (NMOHC); 🇺🇸 Albuquerque, New Mexico, United States

University of New Mexico Cancer Center; 🇺🇸 Albuquerque, New Mexico, United States

Associated Medical Professionals of NY, PLLC; 🇺🇸 Syracuse, New York, United States

Oregon Urology Institute; 🇺🇸 Springfield, Oregon, United States

VA North Texas Health Care System; 🇺🇸 Dallas, Texas, United States

Dr. Irving Fishman's Office; 🇺🇸 Houston, Texas, United States

Urology Clinics of North Texas; 🇺🇸 Dallas, Texas, United States

Dr. Ned Stein's Office; 🇺🇸 Houston, Texas, United States

Houston Willowbrook Radiation Oncology; 🇺🇸 Houston, Texas, United States

Texas Urology Specialists-The Woodlands; 🇺🇸 The Woodlands, Texas, United States

Texas Urology Specialists; 🇺🇸 Tomball, Texas, United States

Potomac Urology Center; 🇺🇸 Alexandria, Virginia, United States

Urology of Virginia, PLLC; 🇺🇸 Virginia Beach, Virginia, United States

MultiCare Regional Cancer Center - Gig Harbor; 🇺🇸 Gig Harbor, Washington, United States

Salem VA Medical Center; 🇺🇸 Salem, Virginia, United States

MultiCare Regional Cancer Center - Tacoma; 🇺🇸 Tacoma, Washington, United States

VA Caribbean Healthcare System; 🇵🇷 San Juan, Puerto Rico

Arizona Center for Cancer Care - Peoria; 🇺🇸 Peoria, Arizona, United States

The University of Chicago; 🇺🇸 Chicago, Illinois, United States

Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States

New Jersey Urology - West Orange; 🇺🇸 West Orange, New Jersey, United States

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States

Arizona Oncology Services Foundation; 🇺🇸 Multiple Locations, Arizona, United States

Arizona Urology Specialists; 🇺🇸 Glendale, Arizona, United States

Arizona Center for Cancer Care - Shea; 🇺🇸 Scottsdale, Arizona, United States

Arizona Center for Cancer Care - Surprise; 🇺🇸 Surprise, Arizona, United States

Arizona Center for Cancer Care - Osborne; 🇺🇸 Scottsdale, Arizona, United States

Clinical Research Center of Florida; 🇺🇸 Pompano Beach, Florida, United States

New Jersey Urology - Englewood; 🇺🇸 Englewood, New Jersey, United States

VA Sierra Nevada Health Care System; 🇺🇸 Reno, Nevada, United States

Carolina Urologic Research Center, LLC; 🇺🇸 Myrtle Beach, South Carolina, United States

Valley View Hospital; 🇺🇸 Glenwood Springs, Colorado, United States

Colorado Clinical Research; 🇺🇸 Lakewood, Colorado, United States

Advanced Urology; 🇺🇸 Parker, Colorado, United States

Arizona Center for Cancer Care - Deer Valley; 🇺🇸 Phoenix, Arizona, United States

Durham VA Health Care System; 🇺🇸 Durham, North Carolina, United States

South Texas San Antonio VA Healthcare System; 🇺🇸 San Antonio, Texas, United States

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

VA Portland Health Care System; 🇺🇸 Portland, Oregon, United States

James A. Haley Veteran's Hospital; 🇺🇸 Tampa, Florida, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

Florida Urology Partners; 🇺🇸 Tampa, Florida, United States

Adult & Pediatric Urology, P.C.; 🇺🇸 Omaha, Nebraska, United States

Southeast Louisiana Veterans Health Care System; 🇺🇸 New Orleans, Louisiana, United States

Kansas City VA Medical Center; 🇺🇸 Kansas City, Missouri, United States

Ralph H. Johnson Veterans Affairs Medical Center; 🇺🇸 Charleston, South Carolina, United States

Urology Austin; 🇺🇸 Austin, Texas, United States

Austin Urology Institute; 🇺🇸 Austin, Texas, United States

Austin Urology Institute - Northwest Austin Cancer Center; 🇺🇸 Austin, Texas, United States

Hunter Holmes McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States

James J. Peters VA Medical Center; 🇺🇸 Bronx, New York, United States