Accelerating Drug Development in Hormone-Naïve Prostate Cancer through Multimodal Therapy Strategies: The MetaCURE Phase 2 Randomized Clinical Trial.
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McHugh Deaglan, Dallos Matthew, Teo Min Yuen, McBride Sean M, Gopalan Anuradha, Arfe Andrea, Gaffney Christopher D, Amjed Mehak, McCann Patrick J, Benoliel Hannah, Autio Karen A, Goh Alvin C, DeRudder Kevin, Ryan Catherine J, Szmulewitz Russell Z, Morgans Alicia K, Bubley Glenn J, Gupta Shilpa, Klein Eric A, Nguyen Paul L, Kibel Adam S, Wagner Andrew A, Kaplan Irving D, Eggener Scott, Einstein David J, Acosta Andres M, Tendulkar Rahul, VanderWeele David J, Catalona William, Sachdev Sean, Liauw Stanley L, Eastham James A, Taplin Mary-Ellen, Scher Howard I
Аннотация
PATIENTS AND METHODS: In the MetaCURE trial, patients with untreated, high-risk localized (cohort A) or low-volume metastatic (cohort B) disease were randomized 1:1 to apalutamide or apalutamide and abiraterone acetate plus prednisone and androgen deprivation therapy for 10 months. Cohort B also received stereotactic body radiotherapy (RT) at 4 months. All patients underwent a radical prostatectomy (6 months ± postoperative RT at 10 months). The primary endpoint was pathologic complete response (pCR; no residual tumor) or minimal residual disease (MRD; ≤5 mm residual carcinoma), and the secondary endpoint an undetectable PSA following testosterone (T) recovery (T ≥ 150 ng/dL) at 24 months.
RESULTS: A pCR or MRD was achieved in 4 [12%; 90% confidence interval (CI), 4%-26%] and 5 (15%; 90% CI, 6%-29%) patients in cohorts A and B, respectively. Undetectable PSA and T-recovery at 24 months occurred in 20 (61%; 95% CI, 42%-77%) patients in cohort A and 13 (39%; 95% CI, 23%-58%) patients in cohort B.
CONCLUSIONS: MMT for newly diagnosed high-risk localized and low-volume metastatic prostate cancer is feasible, safe, and provides a rapid readout of efficacy. A significant proportion of patients, including those with oligometastatic disease, maintained an undetectable PSA following T-recovery at the 2-year endpoint. These results have informed the design of an adaptive trial using MMT on a continuous basis to prioritize effective approaches for further study.