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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.

AbstractPURPOSE:
To investigate the utility of 153Sm 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 153Sm (2.0 mCi/kg intravenously × 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 153Sm. The secondary objectives were to: (1) assess the completion rate for the regimen of 153Sm 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 153Sm and salvage EBRT was well tolerated. Although the toxicity profile supports study of 153Sm in high-risk disease, it may not be beneficial in men receiving EBRT.
AuthorsRichard K Valicenti, Stephanie L Pugh, Edouard J Trabulsi, Oliver Sartor, Eric C Ko, Michael R Girvigian, Seth A Rosenthal, Mark E Shaves, Jeannie H Hoffman-Censits, John Schallenkamp, Howard M Sandler
JournalInternational journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 100 Issue 3 Pg. 695-701 (03 01 2018) ISSN: 1879-355X [Electronic] United States
PMID29413282 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2017 Elsevier Inc. All rights reserved.
Chemical References
  • Organometallic Compounds
  • Organophosphorus Compounds
  • samarium Sm-153 lexidronam
  • Prostate-Specific Antigen
Topics
  • Aged
  • Aged, 80 and over
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Grading
  • Organometallic Compounds (adverse effects, therapeutic use)
  • Organophosphorus Compounds (adverse effects, therapeutic use)
  • Prostate-Specific Antigen (blood)
  • Prostatectomy
  • Prostatic Neoplasms (blood, pathology, radiotherapy, surgery)
  • Salvage Therapy (methods)
  • Treatment Failure

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