Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026
Accelerating Drug Development in Hormone-Naïve Prostate Cancer through Multimodal Therapy Strategies: The MetaCURE Phase 2 Randomized Clinical Trial.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeTo accelerate prostate cancer drug development and identification of promising therapies, we aimed to establish a framework for a multimodal therapy (MMT) approach using intermediate endpoints of efficacy due to treatment. PATIENTS AND
methodsIn 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.
resultsA 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.
conclusionsMMT 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.
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