Prostate Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria include:

Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature

NCCN Intermediate Risk is defined as having at least one of the following: 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: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
Planning to undergo standard prostate-only external beam radiation therapy
ECOG Performance Status 0-2

Exclusion Criteria include:

Liver disease, including known cirrhosis or active hepatitis
Patients on systemic corticosteroids (>10mg prednisone per day) or other immunosuppressive drugs
Known HIV+ patients
Regional lymph node involvement or distant metastases
Patients planning to receive whole pelvic irradiation
Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given for a maximum of 6 months
Patients who had or plan to have orchiectomy as the form of hormonal ablation
Known sensitivity or allergic reactions to acyclovir or valacyclovir

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

711

Study ID:

NCT01436968

Recruitment Status:

Active, not recruiting

Sponsor:

Candel Therapeutics, Inc.

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There are 70 Locations for this study

See Locations Near You

Arizona Center for Cancer Care - Gilbert
Gilbert Arizona, 85297, United States
Arizona Urology Specialists
Glendale Arizona, 85308, United States
Arizona Oncology Services Foundation
Multiple Locations Arizona, 85260, United States
Arizona Center for Cancer Care - Peoria
Peoria Arizona, 85381, United States
Arizona Center for Cancer Care - Deer Valley
Phoenix Arizona, 85027, United States
Arizona Center for Cancer Care - Osborne
Scottsdale Arizona, 85251, United States
Arizona Center for Cancer Care - Shea
Scottsdale Arizona, 85258, United States
Arizona Center for Cancer Care - Surprise
Surprise Arizona, 85374, United States
Southern Arizona VA Health Care System
Tucson Arizona, 85723, United States
VA Northern California Health Care System
Mather California, 95655, United States
Precision Radiation Oncology
Tustin California, 92780, United States
Valley View Hospital
Glenwood Springs Colorado, 81601, United States
Colorado Clinical Research
Lakewood Colorado, 80228, United States
Advanced Urology
Parker Colorado, 80134, United States
Sibley Memorial Hospital
Washington District of Columbia, 20016, United States
21st Century Oncology
Fort Lauderdale Florida, 33324, United States
21st Century Oncology
Lakewood Ranch Florida, 34202, United States
21st Century Oncology
Naples Florida, 34102, United States
21st Century Oncology
Plantation Florida, 33324, United States
Clinical Research Center of Florida
Pompano Beach Florida, 33060, United States
James A. Haley Veteran's Hospital
Tampa Florida, 33612, United States
Florida Urology Partners
Tampa Florida, 33615, United States
Jesse Brown VA Medical Center
Chicago Illinois, 60612, United States
The University of Chicago
Chicago Illinois, 60637, United States
Silver Cross Hospital
New Lenox Illinois, 60451, United States
Southeast Louisiana Veterans Health Care System
New Orleans Louisiana, 70119, United States
VA Maryland Health Care System
Baltimore Maryland, 21201, United States
Chesapeake Urology Research Associates
Baltimore Maryland, 21204, United States
The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21231, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
University of Massachusetts Medical School
Worcester Massachusetts, 01605, United States
Kansas City VA Medical Center
Kansas City Missouri, 64128, United States
Adult & Pediatric Urology, P.C.
Omaha Nebraska, 68114, United States
Sheldon Freedman MD, Ltd.
Las Vegas Nevada, 89144, United States
VA Sierra Nevada Health Care System
Reno Nevada, 89502, United States
New Jersey Urology - Cherry Hill
Cherry Hill New Jersey, 08003, United States
New Jersey Urology - Englewood
Englewood New Jersey, 07631, United States
New Jersey Urology - Milburn
Millburn New Jersey, 07041, United States
New Jersey Urology - Saddle Brook
Saddle Brook New Jersey, 07663, United States
New Jersey Urology - West Orange
West Orange New Jersey, 07052, United States
New Mexico Oncology Hematology Consultants (NMOHC)
Albuquerque New Mexico, 87109, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87131, United States
James J. Peters VA Medical Center
Bronx New York, 10468, United States
Advanced Radiation Centers of New York (Integrated Medical Professionals)
North Hills New York, 11042, United States
Associated Medical Professionals of NY, PLLC
Syracuse New York, 13210, United States
Durham VA Health Care System
Durham North Carolina, 27705, United States
Cincinnati VA Medical Center
Cincinnati Ohio, 45220, United States
VA Portland Health Care System
Portland Oregon, 97239, United States
Oregon Urology Institute
Springfield Oregon, 97477, United States
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Ralph H. Johnson Veterans Affairs Medical Center
Charleston South Carolina, 29401, United States
Carolina Urologic Research Center, LLC
Myrtle Beach South Carolina, 29572, United States
Urology Austin
Austin Texas, 78705, United States
Austin Urology Institute
Austin Texas, 78758, United States
Austin Urology Institute - Northwest Austin Cancer Center
Austin Texas, 78759, United States
VA North Texas Health Care System
Dallas Texas, 75216, United States
Urology Clinics of North Texas
Dallas Texas, 75231, United States
Dr. Irving Fishman's Office
Houston Texas, 77030, United States
Houston Willowbrook Radiation Oncology
Houston Texas, 77070, United States
Dr. Ned Stein's Office
Houston Texas, 77074, United States
South Texas San Antonio VA Healthcare System
San Antonio Texas, 78229, United States
The University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Texas Urology Specialists-The Woodlands
The Woodlands Texas, 77385, United States
The Methodist Hospital - The Woodlands
The Woodlands Texas, 77385, United States
Texas Urology Specialists
Tomball Texas, 77375, United States
Potomac Urology Center
Alexandria Virginia, 22311, United States
Hunter Holmes McGuire VA Medical Center
Richmond Virginia, 23249, United States
Salem VA Medical Center
Salem Virginia, 24153, United States
Urology of Virginia, PLLC
Virginia Beach Virginia, 23462, United States
MultiCare Regional Cancer Center - Gig Harbor
Gig Harbor Washington, 98335, United States
MultiCare Regional Cancer Center - Tacoma
Tacoma Washington, 98405, United States
VA Caribbean Healthcare System
San Juan , 00921, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

711

Study ID:

NCT01436968

Recruitment Status:

Active, not recruiting

Sponsor:


Candel Therapeutics, Inc.

How clear is this clinincal trial information?

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