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Clinical Trial
. 2024 Apr 8;24(1):431.
doi: 10.1186/s12885-024-12165-1.

SABR-Dual: a phase II/III trial of two-fraction versus five-fraction stereotactic radiotherapy for localized low- and favorable intermediate-risk prostate cancer

Elisha Fredman  1 , Oded Icht  2 , Assaf Moore  2 , Dimitri Bragilovski  2 , Jonathan Kindler  2 , Shay Golan  3 , Dror Limon  2
Affiliations
Clinical Trial

SABR-Dual: a phase II/III trial of two-fraction versus five-fraction stereotactic radiotherapy for localized low- and favorable intermediate-risk prostate cancer

Elisha Fredman et al. BMC Cancer. .

Abstract

Background: Dose-escalated radiotherapy is known to improve progression free survival in patients with localized prostate cancer, and recent advances have led to the standardization of ultrahypofractionated stereotactic ablative radiotherapy (SABR) delivered in just 5-fractions. Based on the known effectiveness of the accepted though invasive 2-fraction treatment method of high-dose-rate brachytherapy and given the ubiquity of prostate cancer, a further reduction in the number of treatments of external-beam SABR is possible. This study aims to evaluate the safety, efficacy, and non-inferiority of generalizable 2-fraction SABR compared to the current 5-fraction regimen.

Methods: 502 patients will be enrolled on this phase II/III randomized control trial. Eligible patients will have previously untreated low- or favorable intermediate-risk adenocarcinoma of the prostate. Patients will be randomized between standard SABR of 40 Gy in 5 fractions given every-other-day and 27 Gy in 2 fractions at least two days apart but completing within seven days. MRI-based planning, radiopaque hydrogel spacer insertion, and fiducial marker placement are required, and SABR will be delivered on either a standard CT-guided linear accelerator or MR-LINAC. The primary endpoint will be freedom from disease progression, with additional secondary clinical, toxicity, and quality of life endpoints.

Discussion: This study will be the largest prospective randomized trial, adequately powered to demonstrate non-inferiority, comparing 2-fraction SABR to standard 5-fraction SABR for localized prostate cancer. As the protocol does not obligate use of an MRI-LINAC or other adaptive technologies, results will be broadly generalizable to the wider community.

Trial registration: This trial is registered on Clinicaltrials.gov: ClinicalTrials.gov Identifier: NCT06027892.

Keywords: Clinical trial; Hydrogel spacer; Prostate cancer; SABR; Stereotactic radiotherapy.

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Conflict of interest statement

EF serves as a consultant to Boston Scientific for SpaceOAR and receives honoraria for clinical and educational work. Excluding the awarded competitive grant, no support, financial or otherwise, was received in connection with this work. All other authors declare no conflicts of interest and that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Fig. 1
Fig. 1
Schema of the SABR-Dual clinical trial
See this image and copyright information in PMC

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