Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer (PrTK03)
A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer
Researchers at 57 US study centers are recruiting over 700 participants to trial a prostate cancer immunotherapy that both kills cancer cells by imparting a suicide gene and stimulates the body’s immune system to find and kill cancer cells. ProstAtak, the investigatory drug, will be administered to the tumor in combination with radiation and valocyclovir medicine. Follow up will continue every 6 months for 5 years. One third of participants will receive a placebo, but neither the researchers nor the patients will know which they are receiving.
If effective, the treatment is expected to improve outcomes for the patients.
- Be 18 years of age or older and male
- Have a diagnosis of prostate cancer meeting clinical criteria
- Not have a known sensitivity or allergic reactions to acyclovir or valacyclovir
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Three courses of ProstAtak® each consisting of AdV-tk injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate 15 – 56 days before radiation, ~3 days before radiation, and then 15-22 days post radiation.
- Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification.
- The prodrug valacyclovir will be administered by mouth at a fixed dose for 14 days after each ProstAtak® injection.
- Follow up will continue each 6 months for up to 5 years.
LOCATIONS AND CONTACTS:
57 study sites are participating across the US. See the full list, along with contact information, here.
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