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Highlights from the 2026 ASCO Genitourinary Cancers Symposium
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| Impact of Age, Number of Cycles of Chemotherapy, and Presence of Visceral Metastases on PSA Response in Patients on Triplet Therapy (ADT + Darolutamide + Docetaxel) for mHSPC: UK Real-World Data from the RECOMMEND Study
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| Amit Bahl, MBBS, FRCR
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| Triplet therapy with ADT, darolutamide, and docetaxel in the UK RECOMMEND real‑world study produced deep, sustained PSA declines in mHSPC, with over 90% of evaluable patients achieving at least a 50% PSA reduction and the majority reaching PSA ≤0.2 ng/mL by 12 months. These robust biochemical responses were consistent across age groups, number of docetaxel cycles, and presence or absence of visceral metastases, supporting the broad applicability of the ARASENS triplet regimen in routine practice.
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| Treatment Utilization Among Patients with mHSPC in Real-World US Settings: A Prostate Cancer Disease Observation (PRECISION) Data Platform Analysis
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| Daniel George, MD
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| In this US real‑world analysis of 43,415 men with mHSPC, nearly 40% received ADT alone, 57% doublet, and only about 4% triplet therapy, indicating underuse of treatment intensification despite guidelines. More intensive regimens were used far more often in oncology than in community urology, where ADT monotherapy remained common.
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| Clinical Outcomes Among Patients with mHSPC in Contemporary Real-World US Clinical Practice: A Prostate Cancer Disease Observation (PRECISION) Data Platform Analysis
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| A. Oliver Sartor, MD
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| In this large US real‑world PRECISION cohort of 43,415 patients with mHSPC diagnosed 2020–2025, roughly half received ADT alone, about half received doublet, and only a small minority received triplet therapy, despite multiple life‑prolonging options. Doublet and triplet regimens were associated with significantly longer castration resistance‑free survival than ADT alone, and triplet therapy showed the longest overall survival, reinforcing guideline recommendations for early treatment intensification in mHSPC.
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| Androgen-Receptor Pathway Inhibitors Triplet Therapy (ARAAT): Real-World Outcomes in Metastatic Hormone-Sensitive Prostate Cancer
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| Alicia Morgans, MD, MPH
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| In the real‑world ARAAT study of 592 patients with mHSPC treated with triplet therapy, darolutamide + ADT + docetaxel was associated with better outcomes than abiraterone + ADT + docetaxel, including longer time to treatment discontinuation, progression free survival, time to next treatment, and overall survival. Darolutamide triplets also produced deeper and faster PSA responses, with a higher proportion of patients achieving PSA <0.2 ng/mL at 12 and 24 months and a shorter time to reach this threshold.
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| Real-World Comparison of PSA Response in mCSPC Patients Treated with Apalutamide without Docetaxel versus Darolutamide without Docetaxel
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| Mehmet Asim Bilen, MD
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| In this real‑world mCSPC cohort from US community urology practices, apalutamide plus ADT without docetaxel produced deeper and faster PSA responses than darolutamide plus ADT without docetaxel. By 6 months, 75% of apalutamide patients versus 56% of darolutamide patients achieved PSA90, with a shorter median time to PSA90 on apalutamide, supporting a larger therapeutic benefit for apalutamide in this setting.
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| Analysis of Quality-Adjusted Time without Symptoms or Toxicity (Q-TWIST) in Patients with mHSPC: From the ARASENS Trial
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| Brigida Anna Maiorano, MD
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| Brigida Anna Maiorano presented on the ARASENS trial in which darolutamide + ADT + docetaxel not only reduced the risk of death by about one‑third versus ADT + docetaxel, but also increased quality‑adjusted survival time. Using a Q‑TWiST analysis over 53 months, darolutamide yielded an additional 6.3 months of quality‑adjusted time without symptoms or severe toxicity and a 16% relative gain in Q‑TWiST, reflecting more time free of grade 3/4 toxicity and less time in progression despite somewhat longer time living with treatment‑related toxicity.
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| Safety Profile of Darolutamide + ADT Compared to Enzalutamide, Apalutamide, and Abiraterone in mCSPC Prostate Cancer: Results from the First Safety Matching-Adjusted Indirect Comparison
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| Neal D. Shore, MD, FACS
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| Darolutamide + ADT showed a more favorable safety profile than enzalutamide, apalutamide, or abiraterone + ADT in this MAIC of mCSPC trials, with significantly less fatigue versus enzalutamide and apalutamide and less rash versus apalutamide. Numerical trends also favored darolutamide for fractures, falls, and hypertension, supporting its tolerability as an ARPI backbone in metastatic castration‑sensitive disease.
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| EXTRA-PC: A Phase II Trial of Masofaniten (EPI-7386) and Enzalutamide with ADT for Patients with mHSPC
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| Albert Jang, MD
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| EXTRA‑PC is a phase II, single‑institution trial testing dual androgen receptor blockade with masofaniten plus enzalutamide and ADT in treatment‑naïve mHSPC. In a small, high‑risk cohort, 77% achieved PSA <0.2 ng/mL by 6 months with rapid declines and mostly grade 1–2 toxicities, supporting the biologic feasibility and tolerability of combined NTD + LBD AR inhibition, although the study closed early due to discontinuation of masofaniten development rather than safety or futility.
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| A Phase 1/2 Study of MRT-2359, a Highly Selective Oral GSPT1 Molecular Glue Degrader, in Combination with Enzalutamide in mCRPC Harboring AR Ligand Binding Domain Mutations
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| Rahul Parikh, MD, PhD
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| MRT-2359, an oral GSPT1 “molecular glue” degrader that downregulates AR, MYC, and Cyclin D1, showed manageable safety and early antitumor activity when combined with enzalutamide in heavily pretreated mCRPC. In the overall cohort, one-third of evaluable patients had PSA and radiographic responses with a 67% disease control rate, while the AR–ligand-binding–domain–mutant subset had particularly striking benefit, with 100% PSA responses, 40% RECIST partial responses, and durable disease control that is now being taken forward into a focused phase 2 study in AR‑mutant mCRPC.
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| Safety and Efficacy of Pasritamig + Docetaxel in Participants with mCRPC: Initial Results of a Phase 1b Study
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| Manish Patel, MD
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| Pasritamig, a first‑in‑class KLK2‑targeted bispecific T‑cell engager, can be safely combined with full‑dose docetaxel in heavily pretreated mCRPC, with a toxicity profile largely resembling docetaxel alone and no cytokine release syndrome observed. Early efficacy signals are encouraging, with PSA50 and PSA90 responses in 65% and 39% of patients overall and particularly deep responses in taxane‑naïve, bone‑only disease, supporting advancement into the phase 3 KLK2‑PASenger trial of pasritamig plus docetaxel versus docetaxel alone.
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| Efficacy and Safety of Darolutamide and ADT in Patient Subgroups by Baseline Comorbidities and Concomitant Medications: ARANOTE Post Hoc Analyses
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| Fred Saad, CQ, MD, FRCS, FCAHS
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| In ARANOTE, darolutamide + ADT improved radiographic progression‑free survival versus ADT alone across all subgroups, regardless of baseline comorbidity burden or number of concomitant medications, with hazard ratios consistently around 0.5–0.6. Grade 3–5 adverse event rates and discontinuations were similar or lower with darolutamide versus placebo even in patients with ≥5 comorbidities or ≥5 concomitant drugs, reinforcing its favorable tolerability and low drug–drug interaction potential in a typically multimorbid, polytreated mHSPC population.
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| OMAHA-003: Phase 3 Trial of CYP11A1 Inhibitor Opevesostat versus ARPI Switch in Participants with mCRPC After ARPI and Taxane-Based Chemotherapy
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| Evan Yu, MD
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| OMAHA‑003 is a global phase 3 trial comparing the CYP11A1 inhibitor opevesostat plus fludrocortisone versus switching to another ARPI (abiraterone/prednisone or enzalutamide) in mCRPC previously treated with ARPI and taxane chemotherapy. It tests whether upstream blockade of steroidogenesis can improve overall survival versus an ARPI switch in both AR–LBD–mutant and –wild‑type disease.
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