The PrKT03 trial of radiation + immunotherapy for localized prostate cancer


Back in September 2011, a company called Advantagene initiated a randomized, placebo-controlled, Phase III clinical trial (the PrKT01 trial) of an immunotherapeutic agent known as AdV-tk, together with with standard external beam radiation therapy, in highly-defined patients with newly diagnosed, localized prostate cancer.

The study was designed to enroll 711 patients in a 2:1 protocol. In other words, for every patient randomized to the placebo arm of the study, two patients would be randomized to the investigational drug arm.

Eligible patients were required to have either intermediate-risk prostate cancer based on the NCCN definition of intermediate risk (i.e., any one or more of PSA, 10-20 ng/ml; Gleason score, 7; or clinical stage, T2b or T2c) or NCCN high-risk cancer (i.e., any one or more of PSA > 20 ng/ml; Gleason score, 8-10; or clinical stage, T3a). However, the patients with high-risk disease could have only one of the three possible indicators of high risk.

All patients are being treated with a standard course of radiation therapy, the option of 6 months or less of androgen deprivation therapy (as determined by the investigator and the patient prior to the start of treatment), three injections of AdV-tk or a placebo, and 14 days of treatment with oral valacyclovir. Detailed information about the trial protocol is available on the ClinicalTrials.gov web site and a patient brochure is available on the company’s web site as well.

It appears that, as of the current date, the company is still trying to complete recruitment of patients to this trial, which has the potential to demonstrate that the combination of radiation therapy + AdV-tk + valacyclovir can be used to reduce the risk of recurrence of prostate cancer in men with intermediate-risk and some forms of high-risk disease. The study is enrolling patients at 15 centers across the USA, including such prestigious centers as Memorial Sloan-Kettering Cancer Center in New York, The Johns Hopkins University School of Medicine in Baltimore, and the Fox Chase Cancer Center in Philadelphia.

While the New Prostate Cancer InfoLink cannot comment on the likelihood that this trial will or will not show a benefit to treatment with this investigational immunotherapeutic agent, this appears to be a trial that would be appropriate for any man with intermediate- or high-risk, localized prostate cancer if he lives near to one of the 15 study centers. For a patient who had already decided to have external beam radiation therapy, there appears to be little to lose from participation in this trial … and perhaps a great deal to gain.

One Response

  1. It is very much appreciated that you inform and encourage patients to participate in clinical trials.

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