PMID- 29413282 OWN - NLM STAT- MEDLINE DCOM- 20190125 LR - 20221214 IS - 1879-355X (Electronic) IS - 0360-3016 (Print) IS - 0360-3016 (Linking) VI - 100 IP - 3 DP - 2018 Mar 1 TI - First Report of NRG Oncology/Radiation Therapy Oncology Group 0622: A Phase 2 Trial of Samarium-153 Followed by Salvage Prostatic Fossa Irradiation in High-Risk Clinically Nonmetastatic Prostate Cancer After Radical Prostatectomy. PG - 695-701 LID - S0360-3016(17)34143-3 [pii] LID - 10.1016/j.ijrobp.2017.11.024 [doi] AB - PURPOSE: To investigate the utility of (153)Sm lexidronam (Quadramet) in the setting of men with prostate cancer status post radical prostatectomy who develop biochemical failure with no clinical evidence of osseous metastases. PATIENTS AND METHODS: Trial NRG Oncology RTOG 0622 is a single-arm phase 2 trial that enrolled men with pT2-T4, N0-1, M0 prostate cancer status post radical prostatectomy, who meet at least 1 of these biochemical failure criteria: (1) prostate-specific antigen (PSA) > 1.0 ng/mL; (2) PSA > 0.2 ng/mL if Gleason score 9 to 10; or (3) PSA > 0.2 ng/mL if N1. Patients received (153)Sm (2.0 mCi/kg intravenously x 1) followed by salvage external beam radiation therapy (EBRT) to the prostatic fossa (64.8-70.2 Gy in 1.8-Gy daily fractions). No androgen deprivation therapy was allowed. The primary objective was PSA response within 12 weeks of receiving (153)Sm. The secondary objectives were to: (1) assess the completion rate for the regimen of (153)Sm and EBRT; (2) evaluate the hematologic toxicity and other adverse events (AEs) at 12 and 24 weeks; and (3) determine the freedom from progression rate at 2 years. RESULTS: A total of 60 enrolled eligible patients were included in this analysis. Median follow-up was 3.97 years. A PSA response was achieved in 7 of 52 evaluable patients (13.5%), compared with the 25% hypothesized. The 2-year freedom from progression rate was 25.5% (95% confidence interval 14.4%-36.7%), and the biochemical failure rate was 64.4% (95% CI 50.5%-75.2%). Samarium-153 was well tolerated, with 16 (of 60) grade 3 to 4 hematologic AEs and no grade 5 hematologic AEs. Radiation therapy was also well tolerated, with no grade 3 to 5 acute radiation therapy-related AEs and 1 grade 3 to 4 and no grade 5 late radiation therapy-related AEs. CONCLUSIONS: Trial NRG Oncology RTOG 0622 did not meet its primary endpoint of PSA response, although the regimen of (153)Sm and salvage EBRT was well tolerated. Although the toxicity profile supports study of (153)Sm in high-risk disease, it may not be beneficial in men receiving EBRT. CI - Copyright (c) 2017 Elsevier Inc. All rights reserved. FAU - Valicenti, Richard K AU - Valicenti RK AD - University of California Davis Medical Center, Sacramento, California. Electronic address: rkvalicenti@ucdavis.edu. FAU - Pugh, Stephanie L AU - Pugh SL AD - NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania. FAU - Trabulsi, Edouard J AU - Trabulsi EJ AD - Thomas Jefferson University Hospital, Philadelphia, Pennsylvania. FAU - Sartor, Oliver AU - Sartor O AD - Tulane University, New Orleans, Louisiana. FAU - Ko, Eric C AU - Ko EC AD - University of California Davis Medical Center, Sacramento, California. FAU - Girvigian, Michael R AU - Girvigian MR AD - Kaiser Permanente Los Angeles Medical Center, Los Angeles, California. FAU - Rosenthal, Seth A AU - Rosenthal SA AD - Sutter General Hospital, accruals for Radiological Associates of Sacramento, Sacramento, California. FAU - Shaves, Mark E AU - Shaves ME AD - Sentara Norfolk General Hospital, Norfolk, Virginia. FAU - Hoffman-Censits, Jeannie H AU - Hoffman-Censits JH AD - Thomas Jefferson University Hospital, Philadelphia, Pennsylvania. FAU - Schallenkamp, John AU - Schallenkamp J AD - Billings Clinic Cancer Center, accruals for Montana Cancer Consortium CCOP, Billings, Montana. FAU - Sandler, Howard M AU - Sandler HM AD - Cedars-Sinai Medical Center, Los Angeles, CA. LA - eng GR - U10 CA180868/CA/NCI NIH HHS/United States GR - P30 CA093373/CA/NCI NIH HHS/United States GR - U10 CA027469/CA/NCI NIH HHS/United States GR - U10 CA180846/CA/NCI NIH HHS/United States GR - U10 CA037517/CA/NCI NIH HHS/United States GR - UG1 CA233340/CA/NCI NIH HHS/United States GR - U10 CA180822/CA/NCI NIH HHS/United States PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20171121 PL - United States TA - Int J Radiat Oncol Biol Phys JT - International journal of radiation oncology, biology, physics JID - 7603616 RN - 0 (Organometallic Compounds) RN - 0 (Organophosphorus Compounds) RN - 745X144DZY (samarium Sm-153 lexidronam) RN - EC 3.4.21.77 (Prostate-Specific Antigen) SB - IM MH - Aged MH - Aged, 80 and over MH - Humans MH - Male MH - Middle Aged MH - Neoplasm Grading MH - Organometallic Compounds/adverse effects/*therapeutic use MH - Organophosphorus Compounds/adverse effects/*therapeutic use MH - Prostate-Specific Antigen/*blood MH - Prostatectomy MH - Prostatic Neoplasms/blood/pathology/*radiotherapy/surgery MH - Salvage Therapy/*methods MH - Treatment Failure PMC - PMC6281168 MID - NIHMS1507759 COIS- Conflicts of interest: Dr. Pugh reports grants from PCORI grant, outside the submitted work. Dr. Sandler reports stock and fees from AMIC for participating on a medical advisory board, fees from Janssen for participating on a clinical trial steering committee, fees from Ferring and Dendreon for participating on advisory boards, outside the submitted work. EDAT- 2018/02/08 06:00 MHDA- 2019/01/27 06:00 PMCR- 2019/03/01 CRDT- 2018/02/08 06:00 PHST- 2017/06/14 00:00 [received] PHST- 2017/10/26 00:00 [revised] PHST- 2017/11/13 00:00 [accepted] PHST- 2018/02/08 06:00 [entrez] PHST- 2018/02/08 06:00 [pubmed] PHST- 2019/01/27 06:00 [medline] PHST- 2019/03/01 00:00 [pmc-release] AID - S0360-3016(17)34143-3 [pii] AID - 10.1016/j.ijrobp.2017.11.024 [doi] PST - ppublish SO - Int J Radiat Oncol Biol Phys. 2018 Mar 1;100(3):695-701. doi: 10.1016/j.ijrobp.2017.11.024. Epub 2017 Nov 21.