Lantheus Starts Phase 2/3 Trial for Prostate Cancer Imaging Drug

BEDFORD, Mass., Sept. 28, 2026 /CourierPR/ -- Lantheus Holdings, Inc., the leading radiopharmaceutical-focused company dedicated to enabling clinicians to find, fight, and follow disease to deliver better patient outcomes, today announced the first patient has been dosed in SPARROW NCT07831824, a Phase 2/3 registrational trial evaluating LNTH-2401 (68Ga-DOTA-RM2). The Phase 2/3 study includes an initial Phase 2 dose optimization period followed by a Phase 3 diagnostic performance period. The Phase 3 portion of the trial is expected to enroll approximately 400 participants and will evaluate diagnostic performance, safety, and tolerability.

LNTH-2401 is an investigational gallium-68-labeled positron emission tomography (PET) imaging agent that targets the gastrin-releasing peptide receptor (GRPR), a biomarker that is highly expressed in many prostate cancers. The SPARROW study is an open-label, non-randomized, multicenter Phase 2/3 clinical trial evaluating the use of LNTH-2401 PET/CT imaging in prostate cancer. During Phase 2, up to 12 imaging-evaluable participants with newly diagnosed or biochemically recurrent prostate cancer will receive LNTH-2401 PET/CT imaging to determine the optimal administered activity and imaging time window. Phase 2 will also assess biodistribution, radiation dosimetry, image quality, safety, and tolerability.

Data from participants with GRPR-positive lesions are expected to support selection of the administered activity and imaging time window for Phase 3. During Phase 3, approximately 400 participants with newly diagnosed prostate cancer who are at least high risk or have suspected metastatic disease and are eligible for radical prostatectomy with pelvic lymph node dissection will undergo LNTH-2401 PET/CT imaging using the optimized imaging parameters selected during Phase 2. The Phase 3 co-primary endpoints are participant-level sensitivity and specificity of LNTH-2401 PET/CT imaging compared with histopathology. Secondary diagnostic performance assessments include positive predictive value (PPV), negative predictive value (NPV), regional detection performance, comparative summaries versus conventional imaging and/or PSMA PET imaging where applicable, and assessment of inter-reader and intra-reader agreement. Safety and tolerability will also be evaluated.

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The article is available at pmc.ncbi.nlm.nih.gov/articles/PMC10916925.