Clinical Trial for intermediate risk prostate cancer, newly diagnosed

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Below is the announcement recruitng patients for a clincial trial using radiation with and without a prosatate cancer vaccine. Link has the details. Investigators are recruiting patients with newly diagnosed, intermediate-risk prostate cancer to a randomized, controlled, phase 3 study that will test adenovirus-mediated suicide gene therapy in combination with radiotherapy compared with radiotherapy alone. (ClinicalTrials.gov Identifier: NCT00583492). The trial is enrolling patients aged 18 years and older with histologically confirmed adenocarcinoma of the prostate within 180 days prior to registration. They also must have no evidence of metastatic disease. Enrollment began in December 2007, and study completion is set for December 2013. Investigators will measure outcomes of the two arms in terms of freedom from treatment failure. They also will assess secondary outcomes of acute and long-term toxicity, prostate biopsy status at 2 years, freedom from distant metastases, disease-specific and overall survival, and quality of life. During the trial, clinicians will assess any effects of the gene therapy on PSA doubling time after PSA failure. They also hope to determine any possible association between the primary and

secondary outcomes and adenovirus persistence, as well as any association between the outcomes and immunologic responses. More details on this trial can be found at clinicaltrials.gov

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