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

Svend O. Freytag, Hans Stricker, Mei Lu, Mohamed Elshaikh, Ibrahim Aref, Deepak Pradhan, Kenneth Levin, Jae Ho Kim, James Peabody, Farzan Siddiqui, Kenneth Barton, Jan Pegg, Yingshu Zhang, Jingfang Cheng, Nancy Oja-Tebbe, Renee Bourgeois, Nilesh Gupta, Zhaoli Lane, Ron Rodriguez, Theodore DeWeese & 1 others Benjamin Movsas

Research output: Contribution to journalArticle

Abstract

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

Original languageEnglish (US)
Pages (from-to)268-276
Number of pages9
JournalInternational Journal of Radiation Oncology, Biology, Physics
Volume89
Issue number2
DOIs
StatePublished - Jun 1 2014

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adenoviruses
gene therapy
Adenoviridae
Genetic Therapy
radiation therapy
Prostatic Neoplasms
Radiotherapy
cancer
Biopsy
Prostate
Quality of Life
influenza
metastasis
Neutropenia
toxicity
Thrombocytopenia
Human Influenza
grade
safety
incidence

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation
  • Cancer Research

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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.; Stricker, Hans; Lu, Mei; Elshaikh, Mohamed; Aref, Ibrahim; Pradhan, Deepak; Levin, Kenneth; Kim, Jae Ho; Peabody, James; Siddiqui, Farzan; Barton, Kenneth; Pegg, Jan; Zhang, Yingshu; Cheng, Jingfang; Oja-Tebbe, Nancy; Bourgeois, Renee; Gupta, Nilesh; Lane, Zhaoli; Rodriguez, Ron; DeWeese, Theodore; Movsas, Benjamin.

In: International Journal of Radiation Oncology, Biology, Physics, Vol. 89, No. 2, 01.06.2014, p. 268-276.

Research output: Contribution to journalArticle

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 2014, 'Prospective randomized phase 2 trial of intensity modulated radiation therapy with or without oncolytic adenovirus-mediated cytotoxic gene therapy in intermediate-risk prostate cancer', International Journal of Radiation Oncology, Biology, Physics, vol. 89, no. 2, pp. 268-276. https://doi.org/10.1016/j.ijrobp.2014.02.034
Freytag, Svend O. ; Stricker, Hans ; Lu, Mei ; Elshaikh, Mohamed ; Aref, Ibrahim ; Pradhan, Deepak ; Levin, Kenneth ; Kim, Jae Ho ; Peabody, James ; Siddiqui, Farzan ; Barton, Kenneth ; Pegg, Jan ; Zhang, Yingshu ; Cheng, Jingfang ; Oja-Tebbe, Nancy ; Bourgeois, Renee ; Gupta, Nilesh ; Lane, Zhaoli ; Rodriguez, Ron ; DeWeese, Theodore ; Movsas, Benjamin. / Prospective randomized phase 2 trial of intensity modulated radiation therapy with or without oncolytic adenovirus-mediated cytotoxic gene therapy in intermediate-risk prostate cancer. In: International Journal of Radiation Oncology, Biology, Physics. 2014 ; Vol. 89, No. 2. pp. 268-276.
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AU - Lu, Mei

AU - Elshaikh, Mohamed

AU - Aref, Ibrahim

AU - Pradhan, Deepak

AU - Levin, Kenneth

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AU - Siddiqui, Farzan

AU - Barton, Kenneth

AU - Pegg, Jan

AU - Zhang, Yingshu

AU - Cheng, Jingfang

AU - Oja-Tebbe, Nancy

AU - Bourgeois, Renee

AU - Gupta, Nilesh

AU - Lane, Zhaoli

AU - Rodriguez, Ron

AU - DeWeese, Theodore

AU - Movsas, Benjamin

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N2 - 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

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