Hypofractionated Radiation Therapy to the Prostate Bed With Intensity-Modulated Radiation Therapy (IMRT): A Phase 2 Trial

Quality-of-Life Outcomes and Toxicity Profile Among Patients With Localized Prostate Cancer After Radical Prostatectomy Treated With Stereotactic Body Radiation: The SCIMITAR Multicenter Phase 2 Trial

“…The acute toxicity rates in our study compare favorably to published hypofractionation series, 25,28,29,33 which report acute grade 2 GU and GI toxicity rates of CTCAE criteria is ~9-13% and 9-18%, respectively. These are similar to the grade 2 acute GU and GI toxicity rates of 9% and 5% in the present study.…”

“…Potential SBRT benefits include leveraging radiobiology (with prostate cancer cells thought to experience greater death with high doses per fraction 18,19 ), increased patient convenience, greater access to care, and lower healthcare costs. [20][21][22][23] While moderately hypofractionated postprostatectomy RT has shown favorable results in several phase II studies and one phase III study, [24][25][26][27][28][29][30][31][32][33][34][35] postprostatectomy SBRT has only been evaluated in two small single-institution phase 1 studies. 36,37 Despite an acceptable toxicity profile, concerns regarding the highly deformable and mobile prostate bed clinical target volume (which is adjacent to the bladder, rectum, and vesicourethal anastomosis), have precluded further study in the phase II setting.…”

Acute Toxicity and Quality of Life in a Post-Prostatectomy Ablative Radiation Therapy (POPART) Multicentric Trial

“…However, differences in the number of patients, fractionation schedules and the duration of follow-up raise some uncertainties and lower the quality of the evidence. More robust data came from a phase II single trial [ 19 ] reporting on 61 patients treated with a salvage hypofractionated regimen of 15 fractions of 3.4 Gy each: with a median follow-up of 16 months, only two cases of acute (primary endpoint) and late > Grade 3 GU events were documented, along with bRFS rates of 95.1%. When approaching extreme hypofractionation, the latest evidence was provided by the largest prospective study of post-prostatectomy SBRT [ 13 ] reporting on 100 participants treated with a median prostate bed dose of 32 Gy in five fractions: at a median follow-up of 29.5 months, acute and late Grade 2 GU toxicities were both 9%, while acute and late Grade 2 GI toxicities were 5% and 0%, respectively.…”

Post-Operative Radiotherapy in Prostate Cancer: Is It Time for a Belt and Braces Approach?

“…For example, in a phase II study of 61 patients treated with 51 Gy in 15 fractions using IMRT and IGRT, with a limited median follow-up of 16 months, 11.5% and 13.1% of patients experienced acute grade 2 or higher GU and GI symptoms, respectively. The late grade 2 or higher GU toxicity rate was 8.2%, and late grade 2 or higher GI toxicity rate was 11.5% without any grade 3 GI adverse event being reported (33). On the other hand, Lewis et al reported 28% grade 3 or higher late GU toxicity and 7% persisting hematuria in 56 patients treated with 65 Gy in 26 fractions, possibly due to the large volume and the high proportion of patients on anticoagulants (34).…”

“…For example, in a phase II study of 61 patients treated with 51 Gy in 15 fractions using IMRT and IGRT, with a limited median follow-up of 16 months, 11.5% and 13.1% of patients experienced acute grade 2 or higher GU and GI symptoms, respectively. The late grade 2 or higher GU toxicity rate was 8.2%, and late grade 2 or higher GI toxicity rate was 11.5% without any grade 3 GI adverse event being reported ( 33 ). On the other hand, Lewis et al.…”