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Prospective randomized phase 2 trial of intensity modulated radiation therapy with or without oncolytic adenovirus-mediated cytotoxic gene therapy in intermediate-risk prostate cancer.

ABSTRACT: 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.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.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.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.

SUBMITTER: Freytag SO

PROVIDER: S-EPMC4026796 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Prospective randomized phase 2 trial of intensity modulated radiation therapy with or without oncolytic adenovirus-mediated cytotoxic gene therapy in intermediate-risk prostate cancer.

Freytag Svend O SO Stricker Hans H Lu Mei M Elshaikh Mohamed M Aref Ibrahim I Pradhan Deepak D Levin Kenneth K Kim Jae Ho JH Peabody James J Siddiqui Farzan F Barton Kenneth K Pegg Jan J Zhang Yingshu Y Cheng Jingfang J Oja-Tebbe Nancy N Bourgeois Renee R Gupta Nilesh N Lane Zhaoli Z Rodriguez Ron R DeWeese Theodore T Movsas Benjamin B

International journal of radiation oncology, biology, physics 20140505 2

<h4>Purpose</h4>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.<h4>Methods and materials</h4>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 ...[more]

PMID: 24837889

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Project description:There has been rapid adoption of newer radiation treatments such as intensity-modulated radiation therapy (IMRT) and proton therapy despite greater cost and limited demonstrated benefit compared with previous technologies.To determine the comparative morbidity and disease control of IMRT, proton therapy, and conformal radiation therapy for primary prostate cancer treatment.Population-based study using Surveillance, Epidemiology, and End Results-Medicare-linked data from 2000 through 2009 for patients with nonmetastatic prostate cancer.Rates of gastrointestinal and urinary morbidity, erectile dysfunction, hip fractures, and additional cancer therapy.Use of IMRT vs conformal radiation therapy increased from 0.15% in 2000 to 95.9% in 2008. In propensity score-adjusted analyses (N = 12,976), men who received IMRT vs conformal radiation therapy were less likely to receive a diagnosis of gastrointestinal morbidities (absolute risk, 13.4 vs 14.7 per 100 person-years; relative risk [RR], 0.91; 95% CI, 0.86-0.96) and hip fractures (absolute risk, 0.8 vs 1.0 per 100 person-years; RR, 0.78; 95% CI, 0.65-0.93) but more likely to receive a diagnosis of erectile dysfunction (absolute risk, 5.9 vs 5.3 per 100 person-years; RR, 1.12; 95% CI, 1.03-1.20). Intensity-modulated radiation therapy patients were less likely to receive additional cancer therapy (absolute risk, 2.5 vs 3.1 per 100 person-years; RR, 0.81; 95% CI, 0.73-0.89). In a propensity score-matched comparison between IMRT and proton therapy (n = 1368), IMRT patients had a lower rate of gastrointestinal morbidity (absolute risk, 12.2 vs 17.8 per 100 person-years; RR, 0.66; 95% CI, 0.55-0.79). There were no significant differences in rates of other morbidities or additional therapies between IMRT and proton therapy.Among patients with nonmetastatic prostate cancer, the use of IMRT compared with conformal radiation therapy was associated with less gastrointestinal morbidity and fewer hip fractures but more erectile dysfunction; IMRT compared with proton therapy was associated with less gastrointestinal morbidity.

Project description:BACKGROUND:Prostate cancer treatment is a significant source of morbidity and spending. Some men with prostate cancer, particularly those with significant health problems, are unlikely to benefit from treatment. OBJECTIVE:To assess relationships between financial incentives associated with urologist ownership of radiation facilities and treatment for prostate cancer. DESIGN, SETTING, AND PARTICIPANTS:A retrospective cohort of Medicare beneficiaries with prostate cancer diagnosed between 2010 and 2012. Patients were further classified by their risk of dying from noncancer causes in the 10 yr following their cancer diagnosis by using a mortality model derived from comparable patients known to be cancer-free. INTERVENTION:Urologists were categorized by their practice affiliation (single-specialty groups by size, multispecialty group) and ownership of a radiation facility. OUTCOME MEASUREMENTS AND ANALYSIS:Use of intensity-modulated radiation therapy (IMRT) and use of any treatment within 1 yr of diagnosis. Generalized estimating equations were used to adjust for patient differences. RESULTS:Among men with newly diagnosed prostate cancer, use of IMRT ranged from 24% in multispecialty groups to 37% in large urology groups (p<0.001). Patients managed in groups with IMRT ownership (n=5133) were more likely to receive IMRT than those managed by single-specialty groups without ownership (43% vs 30%, p<0.001), regardless of group size. Among patients with a very high risk (> 75%) of noncancer mortality within 10 yr of diagnosis, both IMRT use (42% vs 26%, p<0.001) and overall treatment (53% vs 44%, p<0.001) were more likely in groups with ownership than in those without, respectively. CONCLUSIONS:Urologists practicing in single-specialty groups with an ownership interest in radiation therapy are more likely to treat men with prostate cancer, including those with a high risk of noncancer mortality. PATIENT SUMMARY:We assessed treatment for prostate cancer among urologists with varying levels of financial incentives favoring intervention. Those with stronger incentives, as determined by ownership interest in a radiation facility, were more likely to treat prostate cancer, even when treatment was unlikely to provide a survival benefit to the patient.

Dataset Information

Prospective randomized phase 2 trial of intensity modulated radiation therapy with or without oncolytic adenovirus-mediated cytotoxic gene therapy in intermediate-risk prostate cancer.

Publications

Prospective randomized phase 2 trial of intensity modulated radiation therapy with or without oncolytic adenovirus-mediated cytotoxic gene therapy in intermediate-risk prostate cancer.

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