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Highlights from the 2026 ASCO Genitourinary Cancers Symposium
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| An Intra-Patient Contemporaneous Comparison of 18F-Piflufolastat and 18F-Flotufolastat Urinary Radioactivity and Local and Pelvic Region Detection Rates
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| Brian Helfand, MD, PhD
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| In this intra-patient phase 4 study of men with low-PSA biochemical recurrence after prostatectomy, 18F‑flotufolastat showed markedly lower urinary bladder radioactivity than 18F‑piflufolastat, reducing signal that can obscure pelvic lesions. Flotufolastat also achieved higher detection rates overall and in key pelvic regions (including the prostate bed) at very low PSA levels, suggesting potential advantages for targeting salvage therapy.
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| Real-World Outcomes of Radium-223 in the FRONTIER Study: Impact of Prior Up-Front Therapy in mCRPC
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| Takuma Kato, MD, PhD
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| The FRONTIER real-world study from 84 Japanese centers found that radium-223 had similar feasibility, disease control, and survival outcomes in mCRPC patients regardless of whether they had received modern upfront intensification or “vintage” ADT-based therapy during the hormone-sensitive phase. Six-cycle completion rates, time to progression, overall survival, and safety profiles were comparable between groups, while skeletal events were substantially less frequent when bone-modifying agents were used, reinforcing the importance of concurrent bone protection.
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| Real-World Characteristics of Long-Term Survivors with mCRPC Treated with Radium-223: An Analysis of the Global REASSURE Study
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| Saby George, MD, FACP
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| In the global prospective REASSURE registry of 1,472 mCRPC patients treated with radium‑223, 27% survived at least 2 years after starting therapy, with median OS from radium‑223 of 38.1 vs 10.7 months in shorter survivors. Long‑term survivors tended to start radium‑223 earlier with better performance status, lower disease burden and biomarkers, no prior ARPI or taxane, and—critically—were far more likely to complete ≥5 doses, while fractures and second primaries remained relatively infrequent but accumulated over longer follow‑up.
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| 177Lu-PSMA-617 in Combination with ARPI versus 177Lu-PSMA-617 Alone for the Treatment of mCRPC: A Real-World Prostate Cancer Disease Observation (PRECISION) Data Platform Analysis
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| Elisabeth I. Heath, MD
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| This PRECISION real-world analysis found that mCRPC patients who received 177Lu‑PSMA‑617 together with a concomitant ARPI had longer median progression-free survival and overall survival than those treated with 177Lu‑PSMA‑617 alone. After adjustment for baseline and prior-treatment factors, concomitant ARPI use remained associated with significantly lower mortality risk, supporting prospective randomized trials to confirm whether adding ARPI truly improves outcomes beyond 177Lu‑PSMA‑617 monotherapy.
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| Long-Term Outcomes with Radium-223 in mCRPC: US Patient Subset of the 10-Year REASSURE Global Study
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| Celestia Higano, MD, FACP
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| This US subset of the 10‑year REASSURE study found that radium‑223 remained well tolerated long term in 498 men with bone‑predominant mCRPC, with low rates of serious hematologic toxicity and second primary malignancies. Median overall survival from radium‑223 initiation was 17.4 months, patients commonly received life‑prolonging systemic therapies before and after treatment, and fractures were infrequent—especially among those on bone‑protective agents—supporting radium‑223 as a durable, safe option in routine practice.
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| Real-World Effectiveness of Systemic Therapies After 177Lu-PSMA-617 Treatment in Patients with mCRPC: A Prostate Cancer Disease Observation (PRECISION) Data Platform Analysis
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| Xiao X. Wei, MD, MAS
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| In this PRECISION real-world cohort of 442 men with mCRPC who received systemic therapy after 177Lu‑PSMA‑617, nearly half achieved a PSA50 response, and median progression-free and overall survival from subsequent therapy were about 9 and 10 months, respectively. Outcomes remained meaningful whether patients received a post‑LuPSMA ARPI or taxane, and more prior LuPSMA cycles correlated with better post‑treatment survival, indicating that LuPSMA does not preclude benefit from later systemic therapies.
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| Outcomes of 177Lu-PSMA-617 After Sipuleucel-T in Patients with mCRPC: A Real-World Prostate Cancer Disease Observation (PRECISION) Data Platform Analysis
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| Neal Shore, MD, FACS
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| This real-world PRECISION analysis of 290 men with mCRPC previously treated with sipuleucel‑T showed that subsequent 177Lu‑PSMA‑617 produced robust PSA responses and encouraging outcomes, with median PFS 15.2 months and OS 19.8 months. Despite heavy prior ARPI and taxane exposure and a long disease course before Lu‑PSMA, patients still derived substantial benefit, indicating that prior sipuleucel‑T does not diminish the effectiveness of 177Lu‑PSMA‑617.
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| Real-World Outcomes of 177Lu-PSMA-617 in Taxane-Naïve Patients with mCRPC: A Prostate Cancer Disease Observation (PRECISION) Data Platform Analysis
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| Daniel George, MD
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| This real-world PRECISION analysis of 500 taxane-naïve men with mCRPC showed that 177Lu‑PSMA‑617 produced high PSA responses and a median progression-free survival of 13.5 months, closely mirroring PSMAfore trial results. Outcomes were similar whether patients had received one or multiple prior ARPIs, though PFS was longer when Lu‑PSMA was introduced after only one ARPI, supporting earlier use of 177Lu‑PSMA‑617 in the taxane‑naïve setting.
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| Clinical Characteristics and Survival Outcomes in Veterans Receiving Radium-223 for mCRPC
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| Olivia Stojak, BS
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| This VA cohort of 661 veterans with bone-predominant mCRPC treated with radium-223 had a median overall survival of 11.2 months, consistent with expected real-world outcomes. Older age predicted worse survival, but race, baseline PSA, BMI, and tumor suppressor gene alterations (PTEN, TP53, RB1) were not associated with overall survival, suggesting radium-223 provides similar benefit across genomic and demographic subgroups while highlighting the need for better predictive biomarkers.
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| ProTACT: A First-in-Human, Phase 1 Study Evaluating the Safety, Tolerability, and Anti-Tumor Activity of 225Ac-FL-020, an Anti-PSMA Radioconjugate in Patients with mCRPC
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| Aaron Hansen, BSc, MBBS, FRACP
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| This first-in-human ProTACT phase 1 study of the PSMA-targeted alpha radioconjugate 225Ac‑FL‑020 in heavily pretreated mCRPC has shown a favorable early safety profile up to 5 MBq, with no dose-limiting renal or hematologic toxicity and mostly grade 1–2 adverse events, including mild xerostomia. Emerging PSA50–80 responses across 3–5 MBq suggest dose-dependent antitumor activity, and dose escalation has proceeded to 6 MBq to further define the recommended phase 2 dose.
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| AMPLIFY: A Phase 3 Study of 64Cu-SAR-bisPSMA PET in Participants with Biochemical Recurrence of Prostate Cancer
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| Neal Shore, MD, FACS
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| AMPLIFY is a multicenter, single‑arm phase 3 trial testing whether the novel PSMA tracer 64Cu‑SAR‑bisPSMA PET/CT can more accurately detect prostate cancer recurrence in men with biochemical relapse after definitive therapy, using both same‑day and next‑day imaging. Building on phase 2 COBRA data showing higher lesion detection and better contrast—especially on delayed scans—AMPLIFY will enroll about 220 patients in the US and Australia, with diagnostic performance benchmarked against a composite reference standard to support potential FDA approval.
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