PURPOSE: To assess the safety and efficacy of combining oncolytic adenovirus-mediated cytotoxic gene therapy (OAMCGT) with intensity modulated radiation therapy (IMRT) in intermediate-risk prostate cancer.
METHODS AND MATERIALS: Forty-four men with intermediate-risk prostate cancer were randomly assigned to receive either OAMCGT plus IMRT (arm 1; n=21) or IMRT only (arm 2; n=23). The primary phase 2 endpoint was acute (≤ 90 days) toxicity. Secondary endpoints included quality of life (QOL), prostate biopsy (12-core) positivity at 2 years, freedom from biochemical/clinical failure (FFF), freedom from metastases, and survival.
RESULTS: Men in arm 1 exhibited a greater incidence of low-grade influenza-like symptoms, transaminitis, neutropenia, and thrombocytopenia than men in arm 2. There were no significant differences in gastrointestinal or genitourinary events or QOL between the 2 arms. Two-year prostate biopsies were obtained from 37 men (84%). Thirty-three percent of men in arm 1 were biopsy-positive versus 58% in arm 2, representing a 42% relative reduction in biopsy positivity in the investigational arm (P=.13). There was a 60% relative reduction in biopsy positivity in the investigational arm in men with < 50% positive biopsy cores at baseline (P=.07). To date, 1 patient in each arm exhibited biochemical failure (arm 1, 4.8%; arm 2, 4.3%). No patient developed hormone-refractory or metastatic disease, and none has died from prostate cancer.
CONCLUSIONS: Combining OAMCGT with IMRT does not exacerbate the most common side effects of prostate radiation therapy and suggests a clinically meaningful reduction in positive biopsy results at 2 years in men with intermediate-risk prostate cancer.
Written by:
Freytag SO, Stricker H, Lu M, Elshaikh M, Aref I, Pradhan D, Levin K, Kim JH, Peabody J, Siddiqui F, Barton K, Pegg J, Zhang Y, Cheng J, Oja-Tebbe N, Bourgeois R, Gupta N, Lane Z, Rodriguez R, DeWeese T, Movsas B. Are you the author?
Department of Radiation Oncology, Henry Ford Health System, Detroit, Michigan; Vattikuti Urology Institute, Henry Ford Health System, Detroit, Michigan; Public Health Sciences, Henry Ford Health System, Detroit, Michigan; Pathology, Henry Ford Health System, Detroit, Michigan; Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Radiation Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Reference: Int J Radiat Oncol Biol Phys. 2014 Jun 1;89(2):268-76.
doi: 10.1016/j.ijrobp.2014.02.034
PubMed Abstract
PMID: 24837889
UroToday.com Prostate Cancer Section
