Pivotal trial launches of GRPR-targeted PET imaging agent in prostate cancer

The first patient has been dosed in the pivotal phase 2/3 SPARROW trial (NCT07831824), evaluating the investigational gastrin-releasing peptide receptor (GRPR)-targeted PET imaging agent ⁶⁸Ga-DOTA-RM2 (⁶⁸Ga-LNTH-2401) in prostate cancer, Lantheus announced.¹

⁶⁸Ga-DOTA-RM2 is a gallium-68–labeled PET imaging agent that targets GRPR. The study is designed to evaluate the diagnostic performance of the agent against histopathology in men with newly diagnosed or biochemically recurrent prostate cancer.²

“Accurate characterization of disease remains critically important in prostate cancer, particularly as treatment decisions become increasingly personalized,” said Harshad R. Kulkarni, MD, Chief Medical Advisor at BAMF Health and a principal investigator in the SPARROW study, in the news release.¹ “We are pleased to have dosed the first patient at BAMF Health, where our integrated molecular imaging, radiopharmacy, and clinical trials infrastructure supports the evaluation of emerging radiopharmaceutical technologies. GRPR represents a promising and biologically distinct target in prostate cancer, and SPARROW will help define the role GRPR-targeted PET may play in disease detection and characterization.”

SPARROW trial design

SPARROW is an open-label, nonrandomized, multicenter phase 2/3 study. Patients are eligible for enrollment if they have an ECOG performance status of 0 to 2 and adequate organ function.

The initial phase 2 portion will enroll up to 12 imaging-evaluable participants with newly diagnosed or biochemically recurrent prostate cancer. Participants will undergo 5 (±1) mCi (148 to 222 MBq) of 68Ga-DOTA-RM2 PET/CT to determine the administered activity and optimal imaging time window for the subsequent phase 3 portion. The phase 2 evaluation will also assess biodistribution, radiation dosimetry, image quality, safety, and tolerability.

The phase 3 portion is expected to enroll approximately 400 participants with newly diagnosed prostate cancer who have at least high-risk disease or suspected metastatic disease and are eligible for radical prostatectomy with pelvic lymph node dissection. Imaging will be performed using the parameters selected during phase 2.

The phase 3 co-primary end points are participant-level sensitivity and specificity of ⁶⁸Ga-DOTA-RM2 PET/CT compared with histopathology. Secondary measures include positive predictive value, negative predictive value, regional detection performance, comparisons with conventional imaging and/or PSMA-PET imaging when applicable, and assessment of inter-reader and intra-reader agreement. Safety and tolerability also will be assessed.

Primary completion of the trial is expected in September 2029.

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REFERENCES

1. Lantheus announces first patient dosed in SPARROW phase 2/3 registrational trial in prostate cancer. News release. Lantheus Holdings, Inc. September 28, 2026. Accessed September 28, 2026. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-first-patient-dosed-sparrow-phase-23

2. Dose Optimization and Diagnostic Performance in Prostate Cancer (SPARROW [Staging Prostate Cancer With Advanced RM2 Radiotracer Oncologic Workup]) (SPARROW). ClinicalTrials.gov. Last updated September 21, 2026. Accessed September 28, 2026. https://clinicaltrials.gov/study/NCT07831824