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NCT01436968Active, not recruitingPhase 3

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

A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
711 (estimated)
First submitted
19 Sept 2011
Start date
1 Sept 2011
Primary completion date
31 Aug 2024
Lead sponsor
Candel Therapeutics, Inc.
NCT number
NCT01436968

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 711
  • From 1 Sept 2011 to the primary completion date, 31 Aug 2024
  • 73 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients on systemic corticosteroids (\>10mg prednisone per day) or other immunosuppressive drugs
  • 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

Other illness

  • Liver disease, including known cirrhosis or active hepatitis
  • Known HIV+ patients
  • Known sensitivity or allergic reactions to acyclovir or valacyclovir

Other

  • Regional lymph node involvement or distant metastases
  • Patients who had or plan to have orchiectomy as the form of hormonal ablation

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (73)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
VA Caribbean Healthcare System
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San JuanPuerto RicoUnknown status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesUnknown status
New Mexico Oncology Hematology Consultants (NMOHC)
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AlbuquerqueUnited StatesUnknown status
Potomac Urology Center
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AlexandriaUnited StatesUnknown status
Urology Austin
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AustinUnited StatesUnknown status
Austin Urology Institute - Northwest Austin Cancer Center
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AustinUnited StatesUnknown status
Austin Urology Institute
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AustinUnited StatesUnknown status
MidLantic Urology
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Bala-CynwydUnited StatesUnknown status
Chesapeake Urology Research Associates
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BaltimoreUnited StatesUnknown status
The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center
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BaltimoreUnited StatesUnknown status
VA Maryland Health Care System
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BaltimoreUnited StatesUnknown status
Walter Reed National Military Medical Center
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BethesdaUnited StatesUnknown status
Ralph H. Johnson Veterans Affairs Medical Center
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CharlestonUnited StatesUnknown status
New Jersey Urology - Cherry Hill
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Cherry HillUnited StatesUnknown status
Jesse Brown VA Medical Center
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ChicagoUnited StatesUnknown status
The University Of Chicago
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ChicagoUnited StatesUnknown status
Cincinnati VA Medical Center
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CincinnatiUnited StatesUnknown status
VA North Texas Health Care System
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DallasUnited StatesUnknown status
Urology Clinics of North Texas
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DallasUnited StatesUnknown status
Durham VA Health Care System
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DurhamUnited StatesUnknown status
New Jersey Urology - Englewood
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EnglewoodUnited StatesUnknown status
21st Century Oncology
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Fort LauderdaleUnited StatesUnknown status
MultiCare Regional Cancer Center - Gig Harbor
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Gig HarborUnited StatesUnknown status
Arizona Center for Cancer Care - Gilbert
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GilbertUnited StatesUnknown status
Arizona Urology Specialists
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GlendaleUnited StatesUnknown status
Valley View Hospital
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Glenwood SpringsUnited StatesUnknown status
Houston Willowbrook Radiation Oncology
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HoustonUnited StatesUnknown status
Dr. Irving Fishman's Office
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HoustonUnited StatesUnknown status
Dr. Ned Stein's Office
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HoustonUnited StatesUnknown status
Kansas City VA Medical Center
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Kansas CityUnited StatesUnknown status
Colorado Clinical Research
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LakewoodUnited StatesUnknown status
21st Century Oncology
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Lakewood RchUnited StatesUnknown status
Sheldon Freedman, MD Ltd.
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Las VegasUnited StatesUnknown status
VA Northern California Health Care System
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MatherUnited StatesUnknown status
New Jersey Urology - Milburn
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MillburnUnited StatesUnknown status
Carolina Urologic Research Center, LLC
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Myrtle BeachUnited StatesUnknown status
21st Century Oncology
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NaplesUnited StatesUnknown status
Silver Cross Hospital
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New LenoxUnited StatesUnknown status
Southeast Louisiana Veterans Health Care System
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New OrleansUnited StatesUnknown status
Advanced Radiation Centers of New York (Integrated Medical Professionals)
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North HillsUnited StatesUnknown status
Adult & Pediatric Urology, P.C.
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OmahaUnited StatesUnknown status
Advanced Urology
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ParkerUnited StatesUnknown status
Arizona Center for Cancer Care-Peoria
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PeoriaUnited StatesUnknown status
Fox Chase Cancer Center
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PhiladelphiaUnited StatesUnknown status
Arizona Center for Cancer Care - Deer Valley
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PhoenixUnited StatesUnknown status
Arizona Oncology Services Foundation
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Phoenix, Mesa, Scottsdale, SedonaUnited StatesUnknown status
21st Century Oncology
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PlantationUnited StatesUnknown status
Clinical Research Center of Florida
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Pompano BeachUnited StatesUnknown status
VA Portland Health Care System
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PortlandUnited StatesUnknown status
VA Sierra Nevada Health Care System
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RenoUnited StatesUnknown status
Hunter Holmes McGuire VA Medical Center
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RichmondUnited StatesUnknown status
New Jersey Urology - Saddle Brook
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Saddle BrookUnited StatesUnknown status
Salem VA Medical Center
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SalemUnited StatesUnknown status
South Texas San Antonio VA Healthcare System
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San AntonioUnited StatesUnknown status
The University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesUnknown status
Arizona Center for Cancer Care - Osborne
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ScottsdaleUnited StatesUnknown status
Arizona Center for Cancer Care - Shea
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ScottsdaleUnited StatesUnknown status
Oregon Urology Institute
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SpringfieldUnited StatesUnknown status
Arizona Center for Cancer Care-Surprise
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SurpriseUnited StatesUnknown status
Associated Medical Professionals of NY, PLLC
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SyracuseUnited StatesUnknown status
MultiCare Regional Cancer Center - Tacoma
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TacomaUnited StatesUnknown status
James A. Haley Veteran's Hospital
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TampaUnited StatesUnknown status
Florida Urology Partners
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TampaUnited StatesUnknown status
James J Peters VA Medical Center
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The BronxUnited StatesUnknown status
Texas Urology Specialists-The Woodlands
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The WoodlandsUnited StatesUnknown status
The Methodist Hospital - The Woodlands
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The WoodlandsUnited StatesUnknown status
Texas Urology Specialists
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TomballUnited StatesUnknown status
Southern Arizona VA Health Care System
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TucsonUnited StatesUnknown status
Precision Radiation Oncology
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TustinUnited StatesUnknown status
Urology Of Virginia, Pllc
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Virginia BeachUnited StatesUnknown status
Sibley Memorial Hospital
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Washington D.C.United StatesUnknown status
New Jersey Urology - West Orange
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West OrangeUnited StatesUnknown status
University of Massachusetts Medical School
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WorcesterUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.