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.

Authors

• Richard 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

Publication/Presentation Date

3-1-2018

Abstract

PURPOSE: To investigate the utility of

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

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

Volume

100

Issue

3

First Page

695

Last Page

701

ISSN

1879-355X

Published In/Presented At

Valicenti, R. K., Pugh, S. L., Trabulsi, E. J., Sartor, O., Ko, E. C., Girvigian, M. R., Rosenthal, S. A., Shaves, M. E., Hoffman-Censits, J. H., Schallenkamp, J., & Sandler, H. M. (2018). 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. International journal of radiation oncology, biology, physics, 100(3), 695–701. https://doi.org/10.1016/j.ijrobp.2017.11.024

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

29413282

Department(s)

Administration and Leadership

Document Type

Article