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.
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
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There are 70 Locations for this study
Gilbert Arizona, 85297, United States
Glendale Arizona, 85308, United States
Multiple Locations Arizona, 85260, United States
Peoria Arizona, 85381, United States
Phoenix Arizona, 85027, United States
Scottsdale Arizona, 85251, United States
Scottsdale Arizona, 85258, United States
Surprise Arizona, 85374, United States
Tucson Arizona, 85723, United States
Mather California, 95655, United States
Tustin California, 92780, United States
Glenwood Springs Colorado, 81601, United States
Lakewood Colorado, 80228, United States
Parker Colorado, 80134, United States
Washington District of Columbia, 20016, United States
Fort Lauderdale Florida, 33324, United States
Lakewood Ranch Florida, 34202, United States
Naples Florida, 34102, United States
Plantation Florida, 33324, United States
Pompano Beach Florida, 33060, United States
Tampa Florida, 33612, United States
Tampa Florida, 33615, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
New Lenox Illinois, 60451, United States
New Orleans Louisiana, 70119, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21231, United States
Bethesda Maryland, 20889, United States
Worcester Massachusetts, 01605, United States
Kansas City Missouri, 64128, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89144, United States
Reno Nevada, 89502, United States
Cherry Hill New Jersey, 08003, United States
Englewood New Jersey, 07631, United States
Millburn New Jersey, 07041, United States
Saddle Brook New Jersey, 07663, United States
West Orange New Jersey, 07052, United States
Albuquerque New Mexico, 87109, United States
Albuquerque New Mexico, 87131, United States
Bronx New York, 10468, United States
North Hills New York, 11042, United States
Syracuse New York, 13210, United States
Durham North Carolina, 27705, United States
Cincinnati Ohio, 45220, United States
Portland Oregon, 97239, United States
Springfield Oregon, 97477, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Philadelphia Pennsylvania, 19111, United States
Charleston South Carolina, 29401, United States
Myrtle Beach South Carolina, 29572, United States
Austin Texas, 78705, United States
Austin Texas, 78758, United States
Austin Texas, 78759, United States
Dallas Texas, 75216, United States
Dallas Texas, 75231, United States
Houston Texas, 77030, United States
Houston Texas, 77070, United States
Houston Texas, 77074, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
The Woodlands Texas, 77385, United States
The Woodlands Texas, 77385, United States
Tomball Texas, 77375, United States
Alexandria Virginia, 22311, United States
Richmond Virginia, 23249, United States
Salem Virginia, 24153, United States
Virginia Beach Virginia, 23462, United States
Gig Harbor Washington, 98335, United States
Tacoma Washington, 98405, United States
San Juan , 00921, Puerto Rico
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