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

Volumn 89, Issue 2, 2014, Pages 268-276

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

^a HENRY FORD HEALTH SYSTEM   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOPSY; DISEASES; GENE THERAPY; RADIATION EFFECTS; RISK ASSESSMENT; UROLOGY;

BIOCHEMICAL FAILURE; INTENSITY-MODULATED RADIATION THERAPY; INTERMEDIATE RISKS; METASTATIC DISEASE; METHODS AND MATERIALS; PROSTATE CANCERS; RELATIVE REDUCTION; THROMBOCYTOPENIA;

RADIOTHERAPY;

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; FLUCYTOSINE; ONCOLYTIC ADENOVIRUS; VALGANCICLOVIR;

ADULT; AGED; ANEMIA; ARTICLE; BIOCHEMISTRY; CANCER RISK; CANCER SURVIVAL; CLINICAL ARTICLE; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; FATIGUE; FLU LIKE SYNDROME; GASTROINTESTINAL TOXICITY; HEART RIGHT BUNDLE BRANCH BLOCK; HUMAN; HUMAN TISSUE; HYPERGLYCEMIA; HYPERMAGNESEMIA; HYPERTENSION; HYPERTRANSAMINASEMIA; HYPOPHOSPHATEMIA; INFLUENZA; INTENSITY MODULATED RADIATION THERAPY; INTERMEDIATE RISK PATIENT; LEUKOPENIA; LUNG EMBOLISM; LYMPHOCYTOPENIA; MALE; METASTASIS FREE SURVIVAL; MONOTHERAPY; MULTICENTER STUDY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROSTATE BIOPSY; PROSTATE CANCER; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SUICIDE GENE THERAPY; THROMBOCYTOPENIA; TREATMENT FAILURE; URINE RETENTION;

ADENOVIRIDAE; AGED; BIOPSY; COMBINED MODALITY THERAPY; GENETIC THERAPY; HUMANS; MALE; MIDDLE AGED; NEOPLASM, RESIDUAL; ONCOLYTIC VIROTHERAPY; PROSPECTIVE STUDIES; PROSTATE; PROSTATIC NEOPLASMS; QUALITY OF LIFE; RADIOTHERAPY DOSAGE; RADIOTHERAPY, INTENSITY-MODULATED; TIME FACTORS; TREATMENT OUTCOME;

EID: 84899812943     PISSN: 03603016     EISSN: 1879355X     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2014.02.034     Document Type: Article

References (34)

1. G. Hanks, A. Hanlon, and B. Epstein et al. Dose response in prostate cancer with 8-12 years follow-up Int J Radiat Oncol Biol Phys 54 2002 427 435
2. D. Kuban, S. Tucker, and L. Dong et al. Long-term results of the MD Anderson randomized dose-escalation trial for prostate cancer Int J Radiat Oncol Biol Phys 70 2008 67 74
3. A. Zietman, K. Bae, and J. Slater et al. Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: Long-term results from proton radiation oncology group/American college of radiology 95-09 J Clin Oncol 28 2010 1106 1111
4. D. Dearnaley, M. Sydes, and J. Graham et al. Escalated dose versus standard dose conformal radiotherapy in prostate cancer: First results from the MRC RT01 randomized controlled trial Lancet Oncol 8 2007 475 487
5. A. Al-Mamgani, W. van Putten, and W. Heemsbergen et al. Update of Dutch multicenter dose-escalation trial of radiotherapy for localized prostate cancer Int J Radiat Oncol Biol Phys 72 2008 980 988
6. M. Zelefsky, Y. Yamada, and Z. Fuks et al. Long-term results of conformal radiotherapy for prostate cancer: Impact of dose escalation on biochemical tumor control and distant metastases-free survival outcomes Int J Radiat Oncol Biol Phys 71 2008 1028 1033
7. T. Eade, A. Hanlon, and E. Horwitz et al. What dose of external beam radiation therapy is high enough for prostate cancer? Int J Radiat Oncol Biol Phys 68 2007 682 689
8. S. Freytag, K. Rogulski, and D. Paielli et al. A novel three-pronged approach to selectively kill cancer cells: Concomitant viral, double suicide gene, and radiotherapy Hum Gene Ther 9 1998 1323 1333
9. K. Rogulski, K. Zhang, and A. Kolozsvary et al. Pronounced antitumor effects and tumor radiosensitization of double suicide gene therapy Clin Cancer Res 3 1997 2081 2088
10. S. Freytag, M. Khil, and H. Stricker et al. Phase I study of replication-competent adenovirus-mediated double suicide gene therapy for the treatment of locally recurrent prostate cancer Cancer Res 62 2002 4968 4976
11. S. Freytag, H. Stricker, and J. Pegg et al. Phase I study of replication-competent adenovirus-mediated double suicide gene therapy in combination with conventional dose three-dimensional conformal radiation therapy for the treatment of newly-diagnosed, intermediate- to high-risk prostate cancer Cancer Res 63 2003 7497 7506
12. S. Freytag, H. Stricker, and J. Peabody et al. Five-year follow-up of trial of replication-competent adenovirus-mediated suicide gene therapy for treatment of prostate cancer Mol Ther 15 2007 636 642
13. S. Freytag, B. Movsas, and I. Aref et al. Phase I trial of replication-competent adenovirus-mediated suicide gene therapy with IMRT for prostate cancer Mol Ther 15 2007 1016 1023
14. K. Barton, H. Stricker, and S. Brown et al. Phase I study of noninvasive imaging of adenovirus-mediated gene expression in the human prostate Mol Ther 16 2008 1761 1769
15. 131I radioiodine therapy as a definitive treatment for localized prostate cancer Mol Ther 19 2011 1353 1359
16. M. Lu, S. Freytag, and H. Stricker et al. Adaptive seamless design for an efficacy trial of replication-competent adenovirus-mediated suicide gene therapy and radiation in newly-diagnosed prostate cancer (ReCAP Trial) Contemp Clin Trials 32 2011 453 460
17. M. Roach, G. Hanks, and H. Thames et al. Defining biochemical failure following radiotherapy with or without hormone therapy in men with clinically localized prostate cancer: Recommendations of the RTOG-ASTRO Phoenix Consensus Conference Int J Radiat Oncol Biol Phys 65 2006 965 974
18. A. Spalding, S. Diagnault, and H. Sandler et al. Percent positive biopsy cores as a prognostic factor for prostate cancer treated with external beam radiation Urology 69 2007 936 940
19. J. Wei, R. Dunn, and M. Litwin et al. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer Urology 56 2000 899 905
20. M. Sanda, R. Dunn, and J. Michalski et al. Quality of life and satisfaction with outcome among prostate cancer survivors N Engl J Med 358 2008 1250 1261
21. R. Rabin, and F. de Charro EQ-5D: A measure of health status from the EuroQol Group Ann Med 33 2001 337 343
22. D. Kuban, A. el-Mahdi, and P. Schellhammer The significance of post-irradiation prostate biopsy with long-term follow-up Int J Radiat Oncol Biol Phys 24 1992 409 414
23. M. Zelefsky, V. Reuter, and Z. Fuks et al. Influence of local tumor control on distant metastases and cancer related mortality after external beam radiotherapy for prostate cancer J Urol 179 2008 1368 1373
24. J. Crook, S. Malone, and G. Perry et al. Twenty-four-month postradiation prostate biopsies are strongly predictive of 7-year disease-free survival: Results from a Canadian randomized trial Cancer 115 2009 673 679
25. S. Cannistra Phase II trials in Journal of Clinical Oncology J Clin Oncol 27 2009 3073 3076
26. J.H. Kim, S.H. Kim, and S. Brown et al. Selective enhancement by an antiviral agent of the radiation-induced cell killing of human glioma cells transduced with HSV-tk gene Cancer Res 54 1994 6053 6056
27. M. Khil, J.H. Kim, and C. Mullen et al. Radiosensitization by 5-fluorocytosine of human colorectal carcinoma cells in culture transduced with cytosine deaminase gene Clin Cancer Res 2 1996 53 57
28. K. Rogulski, J.H. Kim, and S.H. Kim et al. Glioma cells transduced with an E. coli CD/HSV-1 TK fusion gene exhibit enhanced metabolic suicide and radiosensitivity Hum Gene Ther 8 1997 73 85
29. J. Crook, S. Malone, and G. Perry et al. Postradiotherapy prostate biopsies: What do they really mean? Results for 498 patients Int J Radiat Oncol Biol Phys 48 2000 355 367
30. M. Bolla, L. Collette, and L. Blank et al. Long-term results with immediate androgen suppression and external irradiation in subjects with locally advanced prostate cancer (an EORTC study): A phase III randomised trial Lancet 360 2002 103 106
31. M. Pilepich, K. Winter, and C. Lawton et al. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma- long-term results of phase III RTOG 85-31 Int J Radiat Oncol Biol Phys 61 2005 1285 1290
32. E. Horwitz, K. Bae, and G. Hanks et al. Ten-year follow-up of Radiation Therapy Oncology Group protocol 92-02: A phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer J Clin Oncol 26 2008 2497 2504
33. A. D'Amico, M. Chen, and A. Renshaw et al. Androgen suppression and radiation vs radiation alone for prostate cancer: A randomized trial JAMA 299 2008 289 295
34. C. Jones, D. Hunt, and D. McGowan et al. Radiotherapy and short-term androgen deprivation for localized prostate cancer N Engl J Med 365 2011 107 118