Protocol
11-172
Full Title
A Randomized Controlled Trial of ProstAtak as Adjuvant to Up-Front Radiation Therapy for Localized Prostate Cancer
Purpose
Radiation therapy is one approach to treating early-stage (localized) prostate cancer, but in some men the prostate cancer returns. The purpose of this study is to determine if giving an investigational therapy called ProstAtak to men receiving radiation therapy for localized prostate cancer reduces the risk of recurrence.
ProstAtak consists of a “vector” which carries a piece of a gene from the herpes virus into prostate tumor cells. The vector is injected into the tumor. The patient then receives a herpes drug called valacyclovir, which is changed inside the tumor by the herpes virus gene into a chemical that can kill tumor cells.
Patients in this study will be randomly assigned to receive ProstAtak or a placebo solution via injection, in addition to standard radiation therapy and valacyclovir. Researchers will monitor both groups of patients for several years to life to compare their outcomes.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have early-stage prostate cancer that is localized but determined to be of intermediate to high risk.
- Patients may not have received prior treatment for prostate cancer (although short-term hormone therapy and transurethral prostate removal may be permitted).
- Patients must be planning to have radiation therapy.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Michael Zelefsky at 212-639-6802.
Disease(s)
Prostate Cancer
Prostate Cancer: Localized Disease
Locations
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