Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026
131I-LNTH-1095 Radioligand Therapy plus Enzalutamide versus Enzalutamide Alone in Men with PSMA-Avid Metastatic Castration-Resistant Prostate Cancer: A Phase II Study.
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. Cited by 1 paper.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Future opportunities and nuances with the use of PSMA PET in prostate cancer (MD PET 1).Theranostics · 2026Review
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Authors and funding
18 authors.
Funding
Abstract
purposeThe phase II ARROW study was designed to evaluate radioligand therapy (RLT) with 131I-LNTH-1095, an iodine-131-labeled small molecule targeting prostate-specific membrane antigen (PSMA), in combination with enzalutamide in subjects with metastatic castration-resistant prostate cancer after progression on prior abiraterone therapy. PATIENTS AND
methodsMen ≥18 years with PSMA-positive prostate cancer (PSMA PET tracer uptake >1× liver SUVmean in all CT-measurable lesions) were randomly assigned 2:1 to 131I-LNTH-1095 (4 cycles of 3.7 GBq/dose every 8 weeks) + enzalutamide (160 mg orally once daily) versus enzalutamide alone. The primary endpoint was PSA50 response. Secondary endpoints included radiographic progression-free survival (rPFS), objective response rate, overall survival (OS), and safety.
resultsOf 177 screened subjects, 120 were randomly assigned (80: 131I-LNTH-1095 + enzalutamide; 40: enzalutamide monotherapy). PSA50 response was 62.9% [95% confidence interval (CI), 50.5-74.1] for 131I-LNTH-1095 + enzalutamide versus 31.3% (16.1-50) for enzalutamide alone (P = 0.003). The median rPFS was 14.0 months (95% CI, 8.64-18.20) for 131I-LNTH-1095 + enzalutamide versus 11.5 months (2.79-18.43) for enzalutamide alone (P = 0.10). The incidence of grade ≥3 treatment-emergent adverse events (TEAE) was 65.8% for 131I-LNTH-1095 + enzalutamide versus 41% for enzalutamide monotherapy; the most frequent TEAEs were fatigue (75% vs. 53.8%), nausea (59.2% vs. 33.3%), thrombocytopenia (51.3% vs. 0%), and decreased appetite (48.7% vs. 17.9%), respectively. Two deaths in the 131I-LNTH-1095 + enzalutamide group were considered treatment-related. The study was not powered to detect rPFS and OS differences.
conclusions131I-LNTH-1095 + enzalutamide was associated with a statistically significant improvement in PSA50 response compared with enzalutamide alone despite a lower dosing schedule (4 cycles of 3.7 GBq/dose every 8 weeks) than the other approved PSMA RLT agents. Grade ≥3 adverse events were more frequent with combination therapy, particularly hematologic toxicity.
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