Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT01436968
- Run by
- Candel Therapeutics, Inc.
- People needed
- 711
- Starts
- 2011-09-01
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2025-07-30
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Arizona Urology Specialists — Glendale, Arizona, United States
- Arizona Oncology Services Foundation — Multiple Locations, Arizona, United States
- Arizona Center for Cancer Care - Peoria — Peoria, Arizona, United States
- Arizona Center for Cancer Care - Deer Valley — Phoenix, Arizona, United States
- Arizona Center for Cancer Care - Osborne — Scottsdale, Arizona, United States
- Arizona Center for Cancer Care - Shea — Scottsdale, Arizona, United States
- Arizona Center for Cancer Care - Surprise — Surprise, Arizona, United States
- Southern Arizona VA Health Care System — Tucson, Arizona, United States
- VA Northern California Health Care System — Mather, California, United States
- Precision Radiation Oncology — Tustin, California, United States
- Valley View Hospital — Glenwood Springs, Colorado, United States
- Colorado Clinical Research — Lakewood, Colorado, United States
- Advanced Urology — Parker, Colorado, United States
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
- 21st Century Oncology — Fort Lauderdale, Florida, United States
- 21st Century Oncology — Lakewood Rch, Florida, United States
- 21st Century Oncology — Naples, Florida, United States
- 21st Century Oncology — Plantation, Florida, United States
- Clinical Research Center of Florida — Pompano Beach, Florida, United States
- James A. Haley Veteran's Hospital — Tampa, Florida, United States
- Florida Urology Partners — Tampa, Florida, United States
- Jesse Brown VA Medical Center — Chicago, Illinois, United States
- The University of Chicago — Chicago, Illinois, United States
- Silver Cross Hospital — New Lenox, Illinois, United States
- Arizona Center for Cancer Care - Gilbert — Gilbert, Arizona, United States
Full record on ClinicalTrials.gov
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