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.
- Diseases
- Prostate cancer
- 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
Sites (73)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Caribbean Healthcare System Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| New Mexico Oncology Hematology Consultants (NMOHC) Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Potomac Urology Center Coordinator of this site? Confirm its status | Alexandria | United States | Unknown status |
| Urology Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Austin Urology Institute - Northwest Austin Cancer Center Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Austin Urology Institute Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| MidLantic Urology Coordinator of this site? Confirm its status | Bala-Cynwyd | United States | Unknown status |
| Chesapeake Urology Research Associates Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| VA Maryland Health Care System Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Walter Reed National Military Medical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Ralph H. Johnson Veterans Affairs Medical Center Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| New Jersey Urology - Cherry Hill Coordinator of this site? Confirm its status | Cherry Hill | United States | Unknown status |
| Jesse Brown VA Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The University Of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati VA Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| VA North Texas Health Care System Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Urology Clinics of North Texas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Durham VA Health Care System Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| New Jersey Urology - Englewood Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| 21st Century Oncology Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| MultiCare Regional Cancer Center - Gig Harbor Coordinator of this site? Confirm its status | Gig Harbor | United States | Unknown status |
| Arizona Center for Cancer Care - Gilbert Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Arizona Urology Specialists Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Valley View Hospital Coordinator of this site? Confirm its status | Glenwood Springs | United States | Unknown status |
| Houston Willowbrook Radiation Oncology Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Dr. Irving Fishman's Office Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Dr. Ned Stein's Office Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Kansas City VA Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Colorado Clinical Research Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| 21st Century Oncology Coordinator of this site? Confirm its status | Lakewood Rch | United States | Unknown status |
| Sheldon Freedman, MD Ltd. Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| VA Northern California Health Care System Coordinator of this site? Confirm its status | Mather | United States | Unknown status |
| New Jersey Urology - Milburn Coordinator of this site? Confirm its status | Millburn | United States | Unknown status |
| Carolina Urologic Research Center, LLC Coordinator of this site? Confirm its status | Myrtle Beach | United States | Unknown status |
| 21st Century Oncology Coordinator of this site? Confirm its status | Naples | United States | Unknown status |
| Silver Cross Hospital Coordinator of this site? Confirm its status | New Lenox | United States | Unknown status |
| Southeast Louisiana Veterans Health Care System Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Advanced Radiation Centers of New York (Integrated Medical Professionals) Coordinator of this site? Confirm its status | North Hills | United States | Unknown status |
| Adult & Pediatric Urology, P.C. Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Advanced Urology Coordinator of this site? Confirm its status | Parker | United States | Unknown status |
| Arizona Center for Cancer Care-Peoria Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Arizona Center for Cancer Care - Deer Valley Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Arizona Oncology Services Foundation Coordinator of this site? Confirm its status | Phoenix, Mesa, Scottsdale, Sedona | United States | Unknown status |
| 21st Century Oncology Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Clinical Research Center of Florida Coordinator of this site? Confirm its status | Pompano Beach | United States | Unknown status |
| VA Portland Health Care System Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| VA Sierra Nevada Health Care System Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Hunter Holmes McGuire VA Medical Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| New Jersey Urology - Saddle Brook Coordinator of this site? Confirm its status | Saddle Brook | United States | Unknown status |
| Salem VA Medical Center Coordinator of this site? Confirm its status | Salem | United States | Unknown status |
| South Texas San Antonio VA Healthcare System Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| The University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Arizona Center for Cancer Care - Osborne Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Arizona Center for Cancer Care - Shea Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Oregon Urology Institute Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Arizona Center for Cancer Care-Surprise Coordinator of this site? Confirm its status | Surprise | United States | Unknown status |
| Associated Medical Professionals of NY, PLLC Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| MultiCare Regional Cancer Center - Tacoma Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| James A. Haley Veteran's Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Florida Urology Partners Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| James J Peters VA Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Texas Urology Specialists-The Woodlands Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| The Methodist Hospital - The Woodlands Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Texas Urology Specialists Coordinator of this site? Confirm its status | Tomball | United States | Unknown status |
| Southern Arizona VA Health Care System Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Precision Radiation Oncology Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Urology Of Virginia, Pllc Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
| Sibley Memorial Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| New Jersey Urology - West Orange Coordinator of this site? Confirm its status | West Orange | United States | Unknown status |
| University of Massachusetts Medical School Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.