A phase I pilot study of pre-operative radiotherapy for prostate cancer: Long-term toxicity and oncologic outcomes.

Neoadjuvant radiotherapy (RT) improves disease control in various cancers, and has become an established oncologic treatment strategy. During 2001-2004, we conducted a phase I pilot study assessing the role of short-course pre-operative RT (PreORT) for men with unfavourable intermediate- and high-risk localized prostate cancer. Herein, we present long-term follow-up toxicity and oncologic outcomes.

Eligible patients had histologically proven prostate cancer, cT1-T2N0M0 disease, PSA >15-35 ng/ml regardless of Gleason score, or PSA 10-15 ng/ml with Gleason score ≥7. Patients received 25 Gy in five consecutive daily fractions (5 Gy per fraction) to the prostate-only, followed by radical prostatectomy within 14 days after RT completion. Primary outcomes were intra-operative morbidity, and late genitourinary (GU) and gastrointestinal (GI) toxicities.

In total, 15 patients were enrolled; 14 patients completed PreORT followed by radical prostatectomy, which also included bilateral lymph node dissections in 13 cases. Median follow-up was 12.2 years (range 6.7-16.3 years). Late GU toxicity was common, with 2 patients (13.3%) experiencing G2 toxicity, and 6 patients (40%) G3 toxicity. There were no patients with G4-5 late GU toxicity. Late GI toxicity was infrequent, with only 1 patient (6.7%) experiencing transient G2 proctitis. At last follow-up, 8 (53.3%) and 6 (40%) patients experienced biochemical and metastatic disease recurrence, respectively.

The use of PreORT in men with high-risk prostate cancer is associated with unexpected high-rates of late GU toxicity. Future studies examining the role of RT pre-radical prostatectomy must cautiously select RT technique and dose schedule. Importantly, long-term follow-up data is essential to fully determine the therapeutic index of PreORT in the management of localized disease.

International journal of radiation oncology, biology, physics. 2019 Jan 06 [Epub ahead of print]

Rachel Glicksman, Noelia Sanmamed, John Thoms, Alexandre R Zlotta, Antonio Finelli, Theodorus van der Kwast, Joan Sweet, Michael Jewett, Laurence H Klotz, Tara Rosewall, Neil E Fleshner, Robert G Bristow, Padraig Warde, Alejandro Berlin

Department of Radiation Oncology, University of Toronto, Toronto, Canada. Electronic address: ., Department of Radiation Oncology, University of Toronto, Toronto, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada., Discipline of Oncology, Faculty of Medicine, Memorial University of Newfoundland, St. John's, Canada., Division of Urology, Department of Surgery, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada., Department of Pathology, Toronto General Hospital, University Health Network, Toronto, Canada., Department of Surgery (Urology), Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Manchester Cancer Research Centre, University of Manchester, Manchester, United Kingdom., Department of Radiation Oncology, University of Toronto, Toronto, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada; Techna Institute, University Health Network, Toronto, Canada. Electronic address: .

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