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    1 Comment for this article
    Is race or age a factor to consider in selecting stereotactic ablative radiation for oligometastatic prostate cancer?
    Olorunseun Ogunwobi, MD, PhD | Hunter College of The City University of New York
    The ORIOLE Phase 2 randomized clinical trial results reported by Phillips et al indicate that stereotactic ablative radiation has beneficial effects on progression - free survival and distant metastasis - free survival in patients with oligometastatic prostate cancer. This report will likely change practice by delaying androgen deprivation therapy use in eligible patients wiith oligometastatic prostate cancer. This will likely be welcomed by these patients as they will be spared from the potential side effects of androgen deprivation therapy usage. However, the applicability of this approach was demonstrated in the older age group. While that is understandable, given that prostate cancer is predominantly a disease of the elderly, it is imperative that a phase 3 study includes a good representation of the younger population of patients with oligometastatic prostate cancer. More concerningly, this article by Philips et al does not report the race of the participants. One hopes that study participants were racially diverse and that Black patients in particular were included. This is extremely important for an obvious reason: Black men bear a disproportionate burden of aggressive prostate cancer in the United States. Consequently, it is absolutely necessary that the phase 3 study must include adequate representation of Black men. The scientific community, and prostate cancer patients will benefit from including patients from a broader range of age, and racially diverse participants (including Black men) in all prostate cancer clinical trials.
    CONFLICT OF INTEREST: Olorunseun O. Ogunwobi is a Co-Founder of NucleoBio, Inc
    Original Investigation
    March 26, 2020

    Outcomes of Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer: The ORIOLE Phase 2 Randomized Clinical Trial

    Author Affiliations
    • 1Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland
    • 2Stanford Cancer Institute, Department of Radiation Oncology, School of Medicine, Stanford University, Stanford, California
    • 3Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland
    • 4The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland
    • 5The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland
    • 6Sidney Kimmel Cancer Center, Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania
    • 7Stanford Cancer Institute, Division of Oncology, Department of Medicine, School of Medicine, Stanford University, Stanford, California
    JAMA Oncol. 2020;6(5):650-659. doi:10.1001/jamaoncol.2020.0147
    Key Points

    Question  How effectively does stereotactic ablative radiotherapy prevent progression of disease compared with observation in men with recurrent hormone-sensitive prostate cancer with 1 to 3 metastases?

    Findings  In this phase 2 randomized clinical trial of 54 men, progression of disease at 6 months occurred in 7 of 36 participants (19%) treated with stereotactic ablative radiotherapy and in 11 of 18 participants (61%) undergoing observation, a statistically significant difference.

    Meaning  Stereotactic ablative radiotherapy is a promising treatment approach for men with recurrent hormone-sensitive oligometastatic prostate cancer who wish to delay initiation of androgen deprivation therapy.


    Importance  Complete metastatic ablation of oligometastatic prostate cancer may provide an alternative to early initiation of androgen deprivation therapy (ADT).

    Objective  To determine if stereotactic ablative radiotherapy (SABR) improves oncologic outcomes in men with oligometastatic prostate cancer.

    Design, Setting, and Participants  The Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer (ORIOLE) phase 2 randomized study accrued participants from 3 US radiation treatment facilities affiliated with a university hospital from May 2016 to March 2018 with a data cutoff date of May 20, 2019, for analysis. Of 80 men screened, 54 men with recurrent hormone-sensitive prostate cancer and 1 to 3 metastases detectable by conventional imaging who had not received ADT within 6 months of enrollment or 3 or more years total were randomized.

    Interventions  Patients were randomized in a 2:1 ratio to receive SABR or observation.

    Main Outcomes and Measures  The primary outcome was progression at 6 months by prostate-specific antigen level increase, progression detected by conventional imaging, symptomatic progression, ADT initiation for any reason, or death. Predefined secondary outcomes were toxic effects of SABR, local control at 6 months with SABR, progression-free survival, Brief Pain Inventory (Short Form)–measured quality of life, and concordance between conventional imaging and prostate-specific membrane antigen (PSMA)–targeted positron emission tomography in the identification of metastatic disease.

    Results  In the 54 men randomized, the median (range) age was 68 (61-70) years for patients allocated to SABR and 68 (64-76) years for those allocated to observation. Progression at 6 months occurred in 7 of 36 patients (19%) receiving SABR and 11 of 18 patients (61%) undergoing observation (P = .005). Treatment with SABR improved median progression-free survival (not reached vs 5.8 months; hazard ratio, 0.30; 95% CI, 0.11-0.81; P = .002). Total consolidation of PSMA radiotracer-avid disease decreased the risk of new lesions at 6 months (16% vs 63%; P = .006). No toxic effects of grade 3 or greater were observed. T-cell receptor sequencing identified significant increased clonotypic expansion following SABR and correlation between baseline clonality and progression with SABR only (0.082085 vs 0.026051; P = .03).

    Conclusions and Relevance  Treatment with SABR for oligometastatic prostate cancer improved outcomes and was enhanced by total consolidation of disease identified by PSMA-targeted positron emission tomography. SABR induced a systemic immune response, and baseline immune phenotype and tumor mutation status may predict the benefit from SABR. These results underline the importance of prospective randomized investigation of the oligometastatic state with integrated imaging and biological correlates.

    Trial Registration  ClinicalTrials.gov Identifier: NCT02680587