Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial

Nguyen, Paul Viet; Harzée, L.; Retif, Paul; Joseph, Sophia Margaret; Vogin, Guillaume; Nickers, Philippe

doi:10.1007/s00066-021-01832-y

Cited by 2 publications

(2 citation statements)

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“…The SRBT procedure involved at first placement of two fiducial-marker strands (each containing two gold seeds), a planning computed tomography (CT) scan as well as a planning MRI, both fused thereafter based on fiducial markers. Rectal and bladder preparation were described in our study on whole prostate SBRT ( 11 ). SBRT was delivered as 36.25 Gy in 5 fractions prescribed on the 80% isodose or higher.…”

Section: Methodsmentioning

confidence: 99%

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Stereotactic focal radiotherapy as an alternative treatment for low-risk prostate cancer: Results of a single-arm monocenter Phase-II trial

et al. 2023

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IntroductionSince radical treatments in low risk prostate cancer do not improve overall survival in comparison to active surveillance, preserving quality of life (QOL) remains the key objective. Active surveillance of indolent prostate cancer avoids curative treatment side-effects but necessitates repeated biopsies. Focal stereotactic body radiation therapy (focal SBRT) may be an alternative. This non-randomized Phase-II trial examined the feasibility and safety of focal SBRT for low and favorable intermediate-risk prostate cancer.MethodsPatients were recruited in 2016–2019 if they had: localized CAPRA ≤ 3 prostate adenocarcinoma; an isolated PIRADS≥4 macroscopic tumor on MRI; WHO Performance Status 0-1; and no major urinary symptoms. 36.25 Gy (80% isodose prescription) were delivered in 5 fractions every other day. Primary outcome was delay between focal SBRT and salvage-treatment initiation. Secondary outcomes were: acute/late genitourinary/rectal toxicity; biological, clinical and MRI local control; and change in QOL measures.ResultsOver a median follow-up of 36 months, salvage prostatectomy in the 24 eligible patients was never required. Three-year biochemical progression-free survival was 96%. The single biochemical recurrence was a small (2-mm) Gleason 6 (3 + 3) lesion in the non-irradiated lobe. All 19 patients with ≥1 post-treatment MRI evaluations demonstrated complete radiological response. Acute/late grade ≥3 toxicities did not occur: all acute toxicities were grade-1 genitourinary (38% patients), grade-2 genitourinary (8%), or grade-1 rectal (13%) toxicities. There was one (4%) late grade-1 genitourinary toxicity. QOL was unchanged at last follow-up, as shown by IPSS (2.86 to 3.29, p>0.05), U-QOL (0.71 to 0.67, p>0.05), and IIEF5 (the 14 initially potent patients maintained potency (IIEF5 > 16)).ConclusionFocal SBRT is feasible, well-tolerated, and preserves QOL. This innovative robotized approach challenges active surveillance.

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Section: Methodsmentioning

confidence: 99%

“…Organs-at-risk (rectal wall, bladder wall, bladder neck, and urethra) and dose constraints were defined as we described previously ( 11 ). Contralateral neurovascular bundles and the contralateral external sphincter were specifically delineated for this study ( Figure 1 ).…”

Section: Methodsmentioning

confidence: 99%