VA Northern California Health Care System | Sacramento VA Medical Center
Status and phase
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About
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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria include:
Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature
Planning to undergo standard prostate-only external beam radiation therapy
ECOG Performance Status 0-2
Exclusion Criteria include:
Primary purpose
Allocation
Interventional model
Masking
711 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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