PSMA PET findings in an “EMBARK-like” cohort of patients with high-risk non-metastatic hormone-sensitive prostate cancer: A single center post-hoc retrospective analysis.

Authors

Wesley Armstrong

Wesley Robert Armstrong

UCLA-Caltech Medical Scientist Training Program, Los Angeles

Wesley Robert Armstrong , Kevyn J Clark , Clayton P Smith , Pan Thin , Loic Djaileb , Matthias R. Benz , Robert Evan Reiter , Matthew Rettig , Johannes Czernin , Nicholas George Nickols , Amar Upadhyaya Kishan , Jeremie Calais

Organizations

UCLA-Caltech Medical Scientist Training Program, Los Angeles, UCLA Ahmanson Translational Theranostics Division, Los Angeles, CA, UCLA Department of Radiation Oncology, Los Angeles, CA, Ahmanson Translational Theranostics Division, University of California, Los Angeles, CA, UCLA Ahmanson Translational Theranostics Division, LOS Angeles, CA, University of California-Los Angeles, Los Angeles, CA, UCLA Department of Urology, Los Angeles, CA, UCLA Department of Medical Oncology, Los Angeles, CA, Department of Radiation Oncology, University of California Los Angeles, Los Angeles, CA

Research Funding

No funding received
None.

Background: The EMBARK trial is a phase 3, randomized, study evaluating use of enzalutamide with or without concomitant leuprolide in non-metastatic castrate sensitive prostate cancer patients. Eligibility status for the trial relied upon conventional imaging which under detects metastatic disease in comparison to PSMA-PET imaging. The aim of this post-hoc retrospective analysis was to describe the PSMA-PET findings in a patient population representative of the EMBARK trial. Methods: This was a post-hoc, retrospective analysis of 5 prospective studies of PSMA PET conducted at UCLA from 2016 to 2021 that included patients with recurrent PCa following RP, RT or SRT. Patients were included if they met eligibility for enrollment in the EMBARK trial at the time of their PSMA scan defined as the following: Rising PSA at a level above 1.0ng/mL (post RP and SRT) or 2.0ng/mL > nadir (post-RT), PSA doubling time ≤ 9 months, Serum testosterone ≥ 150 ng/dL. Exclusion criteria constituted: distant metastatic disease as assessed by radiographic imaging, prior hormonal therapy or systemic therapy for prostate cancer. PSMA PET findings (PROMISE miTNM stage, number of lesions) were collected from the clinical imaging reports. Descriptive statistics were used (median, range). Results: From 2002 patients screened, 146 patients were included in the analysis. Median time from primary therapy to PSMA PET was 39 (2.1-261) months. Median pre-scan PSA levels and PSA doubling time in patients who underwent RP (n=85), dRT (n=22), post-RP SRT (n=39) and overall (n=146) were 2.4 ng/mL (1-72.1), 8.3 ng/mL (2.37-202), 2.58 ng/ml (1.1-32.3), 2.7 ng/mL (1-202), and 3.5 months (1-9), 3.3 months (1-9), 4.4 months (1-9), 3.7 (1-9) months, respectively. PSMA-PET was positive in 80%, 41%, 85%, 83% of the RP, dRT, RP + SRT and overall populations, respectively. Poly-metastatic disease (≥5 lesions) was found in 19%, 32%, 21% and 21% of cases, respectively. PSMA-PET detected disease only localized to the prostate fossa (miT+N0M0) in 7%, 32%, 0% and 9% respectively. PSMA-PET detected pelvic nodal disease (miTxN1M0) in 40% 18% 28% and 34% respectively. PSMA PET detected any distant metastatic disease (miTxNxM1) in 33%, 41% 56% and 40% respectively. PSMA-PET detected metastatic nodal only disease (N1 and/or M1a) in 58% 32% 74% and 39% and osseous disease (M1b) in 19% 23% 31% and 23% cases respectively. Conclusions: In this “EMBARK-like” cohort of patients with high-risk nmCS PCa and PSA DT < 9 months, PSMA PET was positive in 83% of patients, detected M1 disease in 40% of patients and over one-fifth of cases presented with 5 or more lesions. PSMA-PET provides novel additional risk stratification for patients with high-risk nmCS PCa without distant metastasis based on conventional imaging. Further studies are needed to assess its independent prognostic value and use for treatment guidance. Clinical trial information: NCT03582774.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary Cancer—Prostate, Testicular, and Penile

Track

Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track

Prostate Cancer–Local-Regional Disease

Clinical Trial Registration Number

NCT03582774

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr 5091)

DOI

10.1200/JCO.2023.41.16_suppl.5091

Abstract #

5091

Poster Bd #

185

Abstract Disclosures