{"doi":"10.1016/j.prro.2023.05.012","title":"A Phase 1 Trial of Focal Salvage Stereotactic Body Radiation Therapy for Radiorecurrent Prostate Cancer","abstract":"PURPOSE: 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. METHODS AND MATERIALS: 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, criteria. Escalation was halted if 2 dose-limiting toxicities occurred, defined as any persistent (>4 days) grade 3 toxicity occurring within the first 3 weeks after SBRT and any grade 3 genitourinary (GU) or grade 4 gastrointestinal (GI) toxicity thereafter. RESULTS: Between August 2018 and May 2022, 8 patients underwent salvage focal SBRT, with a median follow-up of 35 months. No dose-limiting toxic effects were observed on DL1. Two patients were enrolled in DL2 and experienced grade 3 GU toxicities, prompting de-escalation and expansion (n = 6) at the MTD (DL1). The most common toxicities observed were grade ≥2 GU toxicities, with only a single grade 2 GI toxicity and no grade ≥3 GI toxicities. One patient experienced biochemical failure (prostate-specific antigen nadir + 2.0) at 33 months. CONCLUSIONS: The MTD for focal salvage SBRT for isolated intraprostatic radiorecurrence was 40 Gy in 5 fractions, producing a 100% 24-month biochemical progression free survival, with 1 poststudy failure at 33 months. The most frequent clinically significant toxicity was late grade ≥2 GU toxicity.","journal":"Practical Radiation Oncology","year":2023,"id":346353,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":12,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.8191,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":885628,"name":"Nicholas R. Rydzewski","orcid":"0000-0002-9465-9441","position":1,"is_corresponding":false},{"id":586519,"name":"Erica Schott","orcid":null,"position":2,"is_corresponding":false},{"id":958272,"name":"Theresa Cooley-Zgela","orcid":null,"position":3,"is_corresponding":false},{"id":256970,"name":"Holly Ning","orcid":null,"position":4,"is_corresponding":false},{"id":256971,"name":"Jason Cheng","orcid":null,"position":5,"is_corresponding":false},{"id":534763,"name":"Kilian Salerno","orcid":"0000-0002-5782-660X","position":6,"is_corresponding":false},{"id":459196,"name":"Erich P. Huang","orcid":"0000-0002-8458-655X","position":7,"is_corresponding":false},{"id":69965,"name":"Peter A. Pinto","orcid":"0000-0002-0190-5931","position":8,"is_corresponding":false},{"id":289934,"name":"Liza Lindenberg","orcid":"0000-0002-8514-0648","position":9,"is_corresponding":false},{"id":403782,"name":"Esther Mena","orcid":"0000-0003-0015-0597","position":10,"is_corresponding":false},{"id":110328,"name":"Peter L. Choyke","orcid":"0000-0003-1086-8826","position":11,"is_corresponding":false},{"id":110339,"name":"Barış Türkbey","orcid":"0000-0003-0853-6494","position":12,"is_corresponding":false},{"id":281159,"name":"Deborah E. Citrin","orcid":"0000-0002-4391-2734","position":13,"is_corresponding":false},{"id":356302,"name":"Krishnan R. Patel","orcid":"0000-0003-2120-1939","position":0,"is_corresponding":true}],"reference_count":37,"raw_metadata":null,"created_at":"2026-07-19T01:11:48.317335Z","pmid":"37442430","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}