Yasir Alayed1, Andrew Loblaw2, William Chu3, Motasem Al-Hanaqta4, Andrew Chiang5, Suneil Jain6, Hans Chung3, Danny Vesprini3, Gerard Morton3, Ananth Ravi3, Melanie Davidson3, Andrea Deabreu7, Alexandre Mamedov7, Liying Zhang7, Darby Erler3, Patrick Cheung8. 1. Sunnybrook Health Sciences Centre-Odette Cancer Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Division of Radiation Oncology, College of Medicine, King Saud University, Riyadh, Saudi Arabia. 2. Sunnybrook Health Sciences Centre-Odette Cancer Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Department of Health Policy, Measurement, and Evaluation, University of Toronto, Toronto, Canada. 3. Sunnybrook Health Sciences Centre-Odette Cancer Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada. 4. Queen Alia Oncology Center, Royal Medical Services, Amman, Jordan. 5. Carlo Fidani Peel Regional Cancer Centre, Credit Valley Hospital, Mississauga, Canada. 6. Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast, Northern Ireland. 7. Sunnybrook Health Sciences Centre-Odette Cancer Centre, Toronto, Canada. 8. Sunnybrook Health Sciences Centre-Odette Cancer Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada. Electronic address: patrick.cheung@sunnybrook.ca.
Abstract
PURPOSE: High-dose-rate brachytherapy boost plus external beam radiation therapy is an established option for intermediate-risk prostate cancer (PCa). Stereotactic body radiation therapy (SBRT) boost can potentially mimic high-dose-rate boost and could be a viable alternative. Here we report the long-term outcomes of a phase 1 dose-escalation trial of single-fraction SBRT boost. METHODS AND MATERIALS: Patients had intermediate-risk PCa and were accrued to 3 different SBRT single-fraction dose-level cohorts (10 Gy, 12.5 Gy, and 15 Gy). All received supplemental radiation therapy afterwards (37.5 Gy in 15 fractions). Three gold fiducials were implanted for image guidance. Patients were simulated and treated with a foley catheter and intrarectal balloon. A T2 magnetic resonance imaging scan was used for contouring, and a cine magnetic resonance imaging scan was used to calculate patient-specific internal target volume margins. Toxicity and quality-of-life data were collected using Common Terminology Criteria for Adverse Events v3.0 and the Expanded Prostate Cancer Index Composite. RESULTS: 30 patients were accrued, 10 in each cohort. Median follow-up was 72 months. 60% had unfavorable intermediate-risk PCa. Two patients in the 15 Gy cohort developed late grade ≥3 gastrointestinal and genitourinary toxicity, with 1 patient suffering from a grade-4 rectal fistula after a rectal ulcer was biopsied repeatedly. Two patients had biochemical failure. Median PSA nadir was 0.4 ng/mL with 10 Gy, 0.09 ng/mL with 12.5 Gy and 0.07 ng/mL with 15 Gy. Median PSA at 4 years as well as proportion achieving a nadir <0.2 ng/mL improved significantly with higher doses. There was no significant change in quality of life from baseline in any of the domains, and the minimal clinically important change was not statistically different between the 3 cohorts. CONCLUSIONS: Other than a grade 4 toxicity, which may in part be due to repeated biopsies of a rectal ulcer, single-fraction SBRT boost was feasible and well tolerated. Larger studies are warranted to better document the outcomes of such an approach.
PURPOSE: High-dose-rate brachytherapy boost plus external beam radiation therapy is an established option for intermediate-risk prostate cancer (PCa). Stereotactic body radiation therapy (SBRT) boost can potentially mimic high-dose-rate boost and could be a viable alternative. Here we report the long-term outcomes of a phase 1 dose-escalation trial of single-fraction SBRT boost. METHODS AND MATERIALS: Patients had intermediate-risk PCa and were accrued to 3 different SBRT single-fraction dose-level cohorts (10 Gy, 12.5 Gy, and 15 Gy). All received supplemental radiation therapy afterwards (37.5 Gy in 15 fractions). Three gold fiducials were implanted for image guidance. Patients were simulated and treated with a foley catheter and intrarectal balloon. A T2 magnetic resonance imaging scan was used for contouring, and a cine magnetic resonance imaging scan was used to calculate patient-specific internal target volume margins. Toxicity and quality-of-life data were collected using Common Terminology Criteria for Adverse Events v3.0 and the Expanded Prostate Cancer Index Composite. RESULTS: 30 patients were accrued, 10 in each cohort. Median follow-up was 72 months. 60% had unfavorable intermediate-risk PCa. Two patients in the 15 Gy cohort developed late grade ≥3 gastrointestinal and genitourinary toxicity, with 1 patient suffering from a grade-4 rectal fistula after a rectal ulcer was biopsied repeatedly. Two patients had biochemical failure. Median PSA nadir was 0.4 ng/mL with 10 Gy, 0.09 ng/mL with 12.5 Gy and 0.07 ng/mL with 15 Gy. Median PSA at 4 years as well as proportion achieving a nadir <0.2 ng/mL improved significantly with higher doses. There was no significant change in quality of life from baseline in any of the domains, and the minimal clinically important change was not statistically different between the 3 cohorts. CONCLUSIONS: Other than a grade 4 toxicity, which may in part be due to repeated biopsies of a rectal ulcer, single-fraction SBRT boost was feasible and well tolerated. Larger studies are warranted to better document the outcomes of such an approach.
Authors: Eric Leung; Adam P Gladwish; Melanie Davidson; Amandeep Taggar; Vikram Velker; Elizabeth Barnes; Lucas Mendez; Elysia Donovan; Lilian T Gien; Allan Covens; Danielle Vicus; Rachel Kupets; Helen MacKay; Kathy Han; Patrick Cheung; Liying Zhang; Andrew Loblaw; David P D'Souza Journal: JAMA Oncol Date: 2022-06-01 Impact factor: 33.006