biostudies-literaturePatel KRIntramural NIH HHS540-550https://www.ebi.ac.uk/biostudies/studies/S-EPMC10782822biostudies-literatureUnknown13(6)<h4>Purpose</h4>NCT03253744 was a phase 1 trial to identify the maximum tolerated dose (MTD) of image-guided, focal, salvage stereotactic body radiation therapy (SBRT) for patients with locally radiorecurrent prostate cancer. Additional objectives included biochemical control and imaging response.<h4>Methods and materials</h4>The trial design included 3 dose levels (DLs): 40 Gy (DL1), 42.5 Gy (DL2), and 45 Gy (DL3) in 5 fractions delivered ≥48 hours apart. The prescription dose was delivered to the magnetic resonance- and prostate-specific membrane antigen imaging-defined tumor volume. Dose escalation followed a 3+3 design with a 3-patient expansion at the MTD. Toxicities were scored until 2 years after completion of SBRT using Common Terminology Criteria for Adverse Events, version 5.0, cPractical radiation oncologyA Phase 1 Trial of Focal Salvage Stereotactic Body Radiation Therapy for Radiorecurrent Prostate Cancer.PMC10782822ZIA BC011552Salerno KCitrin DEChoyke PSchott ENing HCooley-Zgela THuang EPPatel KRTurkbey BPinto PAMena ERydzewski NRLindenberg LCheng JfalseA Phase 1 Trial of Focal Salvage Stereotactic Body Radiation Therapy for Radiorecurrent Prostate Cancer.<h4>Purpose</h4>NCT03253744 was a phase 1 trial to identify the maximum tolerated dose (MTD) of image-guided, focal, salvage stereotactic body radiation therapy (SBRT) for patients with locally radiorecurrent prostate cancer. Additional objectives included biochemical control and imaging response.<h4>Methods and materials</h4>The trial design included 3 dose levels (DLs): 40 Gy (DL1), 42.5 Gy (DL2), and 45 Gy (DL3) in 5 fractions delivered ≥48 hours apart. The prescription dose was delivered to the magnetic resonance- and prostate-specific membrane antigen imaging-defined tumor volume. Dose escalation followed a 3+3 design with a 3-patient expansion at the MTD. Toxicities were scored until 2 years after completion of SBRT using Common Terminology Criteria for Adverse Events, version 5.0, c2023-01-01T00:00:00Z2023 Nov-Dec2026-06-02T06:17:22.545Z2025-04-04T09:59:10.456ZS-EPMC107828223744243010.1016/j.prro.2023.05.012