Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
Public ClinicalTrials.gov record NCT01436968. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01436968
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 711 participants
Conditions and interventions
Conditions
Interventions
- Aglatimagene besadenovec + valacyclovir Biological
- Placebo + valacyclovir Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2011 (Type not available)
- Primary completion
- Aug 2024 (Actual)
- Completion
- Dec 2030 (Estimated)
- Last update posted
- Oct 2, 2026
2011 – 2030
United States locations
- U.S. sites
- 72
- U.S. states
- 23
- U.S. cities
- 59
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Center for Cancer Care - Gilbert | Gilbert | Arizona | 85297 | — |
| Arizona Urology Specialists | Glendale | Arizona | 85308 | — |
| Arizona Center for Cancer Care - Peoria | Peoria | Arizona | 85381 | — |
| Arizona Center for Cancer Care - Deer Valley | Phoenix | Arizona | 85027 | — |
| Arizona Oncology Services Foundation | Phoenix, Mesa, Scottsdale, Sedona | Arizona | 85260 | — |
| Arizona Center for Cancer Care - Osborne | Scottsdale | Arizona | 85251 | — |
| Arizona Center for Cancer Care - Shea | Scottsdale | Arizona | 85258 | — |
| Arizona Center for Cancer Care - Surprise | Surprise | Arizona | 85374 | — |
| Southern Arizona VA Health Care System | Tucson | Arizona | 85723 | — |
| VA Northern California Health Care System | Mather | California | 95655 | — |
| Precision Radiation Oncology | Tustin | California | 92780 | — |
| Valley View Hospital | Glenwood Springs | Colorado | 81601 | — |
| Colorado Clinical Research | Lakewood | Colorado | 80228 | — |
| Advanced Urology | Parker | Colorado | 80134 | — |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| 21st Century Oncology | Fort Lauderdale | Florida | 33324 | — |
| 21st Century Oncology | Lakewood Rch | Florida | 34202 | — |
| 21st Century Oncology | Naples | Florida | 34102 | — |
| 21st Century Oncology | Plantation | Florida | 33324 | — |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | — |
| James A. Haley Veteran's Hospital | Tampa | Florida | 33612 | — |
| Florida Urology Partners | Tampa | Florida | 33615 | — |
| Jesse Brown VA Medical Center | Chicago | Illinois | 60612 | — |
| The University of Chicago | Chicago | Illinois | 60637 | — |
| Silver Cross Hospital | New Lenox | Illinois | 60451 | — |
| Southeast Louisiana Veterans Health Care System | New Orleans | Louisiana | 70119 | — |
| VA Maryland Health Care System | Baltimore | Maryland | 21201 | — |
| Chesapeake Urology Research Associates | Baltimore | Maryland | 21204 | — |
| The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21231 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | — |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01605 | — |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | — |
| Adult & Pediatric Urology, P.C. | Omaha | Nebraska | 68114 | — |
| Sheldon Freedman MD, Ltd. | Las Vegas | Nevada | 89144 | — |
| VA Sierra Nevada Health Care System | Reno | Nevada | 89502 | — |
| New Jersey Urology - Cherry Hill | Cherry Hill | New Jersey | 08003 | — |
| New Jersey Urology - Englewood | Englewood | New Jersey | 07631 | — |
| New Jersey Urology - Milburn | Millburn | New Jersey | 07041 | — |
| New Jersey Urology - Saddle Brook | Saddle Brook | New Jersey | 07663 | — |
| New Jersey Urology - West Orange | West Orange | New Jersey | 07052 | — |
| New Mexico Oncology Hematology Consultants (NMOHC) | Albuquerque | New Mexico | 87109 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131 | — |
| Advanced Radiation Centers of New York (Integrated Medical Professionals) | North Hills | New York | 11042 | — |
| Associated Medical Professionals of NY, PLLC | Syracuse | New York | 13210 | — |
| James J. Peters VA Medical Center | The Bronx | New York | 10468 | — |
| Durham VA Health Care System | Durham | North Carolina | 27705 | — |
| Cincinnati VA Medical Center | Cincinnati | Ohio | 45220 | — |
| VA Portland Health Care System | Portland | Oregon | 97239 | — |
| Oregon Urology Institute | Springfield | Oregon | 97477 | — |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | — |
| Ralph H. Johnson Veterans Affairs Medical Center | Charleston | South Carolina | 29401 | — |
| Carolina Urologic Research Center, LLC | Myrtle Beach | South Carolina | 29572 | — |
| Urology Austin | Austin | Texas | 78705 | — |
| Austin Urology Institute | Austin | Texas | 78758 | — |
| Austin Urology Institute - Northwest Austin Cancer Center | Austin | Texas | 78759 | — |
| VA North Texas Health Care System | Dallas | Texas | 75216 | — |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | — |
| Dr. Irving Fishman's Office | Houston | Texas | 77030 | — |
| Houston Willowbrook Radiation Oncology | Houston | Texas | 77070 | — |
| Dr. Ned Stein's Office | Houston | Texas | 77074 | — |
| South Texas San Antonio VA Healthcare System | San Antonio | Texas | 78229-4404 | — |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Texas Urology Specialists-The Woodlands | The Woodlands | Texas | 77385 | — |
| The Methodist Hospital - The Woodlands | The Woodlands | Texas | 77385 | — |
| Texas Urology Specialists | Tomball | Texas | 77375 | — |
| Potomac Urology Center | Alexandria | Virginia | 22311 | — |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | — |
| Salem VA Medical Center | Salem | Virginia | 24153 | — |
| Urology of Virginia, PLLC | Virginia Beach | Virginia | 23462 | — |
| MultiCare Regional Cancer Center - Gig Harbor | Gig Harbor | Washington | 98335 | — |
| MultiCare Regional Cancer Center - Tacoma | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01436968, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2026 · Synced Oct 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01436968 live on ClinicalTrials.gov.