A Phase 1/2 Trial of Brief Androgen Suppression and Stereotactic Radiation Therapy (FASTR) for High-Risk Prostate Cancer

Bauman, Glenn; Ferguson, Michelle; Lock, Michael; Chen, Jeff; Ahmad, Belal; Venkatesan, Varagur; Sexton, Tracy; D’Souza, David; Loblaw, Andrew; Warner, Andrew; Rodrigues, George

doi:10.1016/j.ijrobp.2015.02.046

Cited by 64 publications

(56 citation statements)

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“…In a clinical investigation of 5 fractions SABR (40Gy to prostate and 25Gy to PLN) with brief androgen suppression (12 months) for high-risk prostate cancer, Bauman et al reported higher than anticipated late rectal toxicity that led to trial termination after recruiting 16 patients [11]. High rates of acute (26%) and late (60%) grade 2 toxicity were observed.…”

Section: Discussionmentioning

confidence: 99%

“…The authors acknowledged the limitations of their study and suggested that several confounding factors; specific frail elderly patient group, contouring on CT scans alone, large high-dose PTV, relaxed OARs constraints, lack of image guidance and manual registration with no fiducial markers were among the candidate factors for such high toxicities. In their letter to editors, Kishan et al argued that the high toxicity reported by Bauman et al [11] originated neither from the prostate being prescribed 40Gy nor the inclusion of the PLN, as their preliminary results in a similar study with a different design, suggests that both approaches were well tolerated by their patient group [17]. In a recent study (the largest of its kind) of predictive parameters for rectal bleeding grade 2 or higher in prostate SABR, multivariate modelling revealed that the rectal volume receiving ≥38Gy ( EQD 2 Gy = 80.6Gy for ) is a strong predictor for high grade haematochezia [18].…”

Section: Discussionmentioning

confidence: 99%

“…SABR-VMAT with flattening-filter free (FFF) photon beams has been reported to be safe and effective [4, 9]. The high dose rates possible with FFF beams and the reduced leakage and scatter dose to the patient are the main reasons behind the increased use in SABR-VMAT for prostate [8–10] and prostate and pelvic lymph nodes [11]. …”

Section: Introductionmentioning

confidence: 99%

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Class solutions for SABR-VMAT for high-risk prostate cancer with and without elective nodal irradiation

et al. 2016

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BackgroundThe purpose of this study is to find the optimal planning settings for prostate SABR-VMAT for high-risk prostate cancer patients irradiated to prostate only (PO) or prostate and pelvic lymph nodes (PPLN).MethodsFor 10 patients, plans using 6MV flattened, flattening-filter-free (FFF) 6MV (6 F) and FFF 10MV (10 F) photon beams with full and partial arc arrangements were generated and compared. The prescribed dose was 40Gy to the prostate with 25Gy to the PLN in 5 fractions. Plans were then evaluated for PTV coverage, dose fall-off, and OAR doses. The number of monitor units and the treatment delivery times were also compared. Statistical differences were evaluated using a paired sample Wilcoxon signed rank test with a significance level of 0.05%.ResultsA total of 150 plans were generated for this study. Acceptable PO plans were obtained using single arcs, while two arcs were necessary for PPLN. All plans were highly conformal (CI ≥1.3 and CN ≥0.90) with no significant differences in the PTV dose coverage. 6MV plans required significantly longer treatment time and had higher dose spillage compared to FFF plans. Superior plans were obtained using 10 F 300° partial arcs for PO with the lowest rectal dose, dose spillage and the shortest treatment times. For PPLN, 6 F and 10 F plans were equivalent.ConclusionsSABR-VMAT with FFF photon beams offers a clear benefit with respect to shorter treatment delivery times and reduced dose spillage. Class solutions using a single 10 F 300° arc for PO and two 10 F or 6 F partial 300° arcs for PPLN are proposed.Electronic supplementary materialThe online version of this article (doi:10.1186/s13014-016-0730-7) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Class solutions for SABR-VMAT for high-risk prostate cancer with and without elective nodal irradiation

et al. 2016

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“…Late rectal toxicity is a known risk with prostate SBRT, especially at larger doses per fraction. 8,9 With evidence suggesting dose escalation to be beneficial for improved biochemical disease free survival, especially for higher risk disease, methods of reducing the toxicity would be beneficial. Whole-body hypothermia has been observed to be a radioprotector for large single-fraction doses to the total body in animal models.…”

Section: Discussionmentioning

confidence: 99%

“…Early evaluations of prostate SBRT have shown excellent efficacy for local control at the risk of increased toxicity with higher doses per fraction. [3][4][5][6][7][8][9][10] Normal tissue radioprotectors may be useful in early clinical trial dose optimization strategies for prostate SBRT. Currently, no method for prevention of rectal toxicity is widely accepted or implemented as standard care for SBRT of the prostate.…”

Section: Introductionmentioning

confidence: 99%

Technical Note: System for evaluating local hypothermia as a radioprotector of the rectum in a small animal model

et al. 2017

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Adaptive ultra‐hypofractionated whole‐pelvic radiotherapy in high‐risk and very high‐risk prostate cancer on 1.5‐Tesla MR‐Linac: Estimated delivered dose and early toxicity results

Gao,

Wei,

Qin

et al. 2024

Chronic Diseases and Translational Medicine

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BackgroundMagnetic resonance (MR)‐guided ultra‐hypofractionated radiotherapy with whole‐pelvic irradiation (UHF‐WPRT) is a novel approach to radiotherapy for patients with high‐risk (HR) and very high‐risk (VHR) prostate cancer (PCa). However, the inherent complexity of adaptive UHF‐WPRT might inevitably result in longer on‐couch time. We aimed to estimate the delivered dose, study the feasibility and safety of adaptive UHF‐WPRT on a 1.5‐Tesla MR‐Linac.MethodsTen patients with clinical stage T3a‐4N0‐1M0‐1c PCa, who consecutively received UHF‐WPRT, were enrolled prospectively. The contours of the target and organ‐at‐risks on the position verification‐MR (PV‐MR), beam‐on 3D‐MR(Bn‐MR), and post‐MR (after radiotherapy delivery) were derived from the pre‐MR data by deformable image registration. The physician then manually adjusted them, and dose recalculation was performed accordingly. GraphPad Prism 9 (GraphPad Prism Software Inc.) was utilized for conducting statistical analyses.ResultsIn total, we collected 188 MR scans (50 pre‐MR, 50 PV‐MR, 44 Bn‐MR, and 44 post‐MR scans). With median 59 min, the mean prostate clinical target volume (CTV)‐V100% was 98.59% ± 2.74%, and the mean pelvic CTVp‐V100% relative percentages of all scans was 99.60% ± 1.18%. The median V29 Gy change in the rectal wall was −2% (−18% to 20%). With a median follow‐up of 9 months, no patient had acute Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or more severe genitourinary (GU) or gastrointestinal (GI) toxicities (0%).ConclusionUHF‐RT to the prostate and the whole pelvis with concomitant boost to positive nodes using an Adapt‐To‐Shape (ATS) workflow was technically feasible for patients with HR and VHR PCa, presenting only mild GU and GI toxicities. The estimated target dose during the beam‐on phase was clinically acceptable based on the 3D‐MR–based dosimetry analysis.Clinical trial registrationChinese Clinical Trial Registry ChiCTR2000033382.

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A Phase 1/2 Trial of Brief Androgen Suppression and Stereotactic Radiation Therapy (FASTR) for High-Risk Prostate Cancer

Cited by 64 publications

References 55 publications

Class solutions for SABR-VMAT for high-risk prostate cancer with and without elective nodal irradiation

Class solutions for SABR-VMAT for high-risk prostate cancer with and without elective nodal irradiation

Technical Note: System for evaluating local hypothermia as a radioprotector of the rectum in a small animal model

Adaptive ultra‐hypofractionated whole‐pelvic radiotherapy in high‐risk and very high‐risk prostate cancer on 1.5‐Tesla MR‐Linac: Estimated delivered dose and early toxicity results

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