Prognostic Value of Interim PSMA-PET Total Tumor Volume for Overall Survival Within ENZA-p, A Randomized Phase 2 Trial of Enzalutamide Versus Enzalutamide Plus [177Lu] Lu-PSMA-617 (ANZUP1901).
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Emmett Louise, Papa Nathan, Sartor Oliver, Morris Michael J, Subramaniam Shalini, Crumbaker Megan, Ayati Narjess, Chen Jeffrey, Herrmann Ken, Gafita Andrei, Swiha Mina, Joshua Anthony M, Weickhardt Andrew, Lee Sze-Ting, Ng Siobhan, Francis Roslyn J, Goh Jeffrey C, Pattison David A, Ho Bao, Khan Sobia, Tan Thean Hsiang, Bills Madison, Nguyen Andrew, Thein Thida, Sidhom George, Wong Keith, Martin Andrew James, Hofman Michael S, Sandhu Shahneen, Thomas Hayley, Stockler Martin R, Davis Ian D, ENZA-p Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Аннотация
DESIGN, SETTING AND PARTICIPANTS: ENZA-p is a randomized, phase 2 trial. Participants with mCRPC and risk factors for early treatment failure with enzalutamide were randomized (1:1) to enzalutamide or enzalutamide + [177Lu]Lu-PSMA-617. Participants underwent baseline and 3-mo [68Ga]Ga-PSMA-11-PET/CT, quantified to derive PSMA-TTV. We evaluated the prognostic value of PSMA-TTV change, and residual PSMA-TTV at 3-mo for OS (NCT04419402).
RESULTS AND LIMITATIONS: This sub-study included 152/162 (94%) randomized participants with a 3-mo PSMA-PET. Median OS was 27 mo (95% confidence interval [CI] 23-30). Baseline median PSMA-TTV 230 ml (interquartile range [IQR] 75-635) and 3-mo PSMA-TTV 103 ml (IQR 24-457). The median change in PSMA-TTV from baseline was -34% (IQR -76% to 16%) with 50/152 (33%) participants with increase in PSMA-TTV. Any increase versus decrease in PSMA-TTV at 3-mo was associated with shorter OS (HR 2.52, 95% CI 1.65-3.85) and decreased 2-yr survival 30% (95% CI 17-43) versus 67% (95% CI 56-75) (log-rank p < 0.0001). Residual 3-mo PSMA-TTV higher versus lower than the median (103 ml) was associated with shorter OS (HR 3.76, 95% CI 2.39-5.92) and lower 2-yr survival 34% (95% CI 23-45) versus 76% (95% CI 64-84) (log-rank p < 0.0001). This association was independent of treatment arm and prostate-specific antigen (PSA) response.
CONCLUSIONS: PSMA-TTV at 3 mos was prognostic for OS independent of study treatment and PSA response in ENZA-p, warranting further prospective validation of interim PSMA-PET response criteria.