TheranosticTrials.org
Lantheus Medical Imaging

Clinical Trial · NCT07831824

Dose Optimization and Diagnostic Performance in Prostate Cancer (SPARROW [Staging Prostate Cancer With Advanced RM2 Radiotracer Oncologic Workup])

Overview

This is an open-label, nonrandomized, multicenter study conducted in two sequential parts: an initial Phase 2 Dose Optimization Period followed by the Phase 3 Diagnostic Performance Period. After the optimal administered activity and imaging time window are selected in Phase 2, Phase 3 will enroll participants with recently diagnosed PCa who are at least high risk or have suspected metastatic disease and are eligible for radical prostatectomy with pelvic lymph node dissection (RP+PLND). Safety assessments throughout the study will include monitoring of adverse events, vital signs, ECGs, and clinical laboratory parameters. Participants will be enrolled sequentially in a nonrandomized manner, with competitive enrollment across study sites.

Sponsor

Lantheus Medical Imaging

Phase

Phase 2/3

Contacts

Eryn Bagley (CONTACT)

clinicaltrials@lantheus.com

978-671-8886

ClinicalTrials.gov

NCT07831824

Drug / Compound

LNTH-2401

Isotope(s):
Target(s):
  • GRPR
Ligand Class: Peptides
Chelator: DOTA
Linker: 4-amino-1-carboxymethylpiperidine

Eligibility

Inclusion

  • Post-radiation therapy (RT), cryotherapy, or brachytherapy: Increase in serum PSA ≥2.0 ng/mL above the nadir, consistent with the American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition.
  • All participants must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate and meet either disease population based on the phase specific criteria below, as applicable.
  • Albumin ≥ 30 g/L.
  • Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN). For participants with known Gilbert's syndrome, ≤ 3 × ULN is permitted.
  • Participants must meet all of the criteria below as defined to be enrolled in the study.
  • Biochemically Recurrent Prostate Cancer (Phase 2 Only) Post-definitive-therapy disease with suspected recurrence, based on elevated prostate-specific antigen (PSA) following definitive therapy, meeting one of the following criteria:
  • Platelets ≥ 100 × 109/L
  • Adequate organ function, defined as follows: Bone marrow reserve:
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN Renal function:
  • Newly Diagnosed Prostate Cancer (Phase 2 and 3): high-risk prostate cancer as defined by the National Comprehensive Cancer Network (NCCN) Guidelines, Version 5.2026 (clinical stage ≥T3a, or PSA \>20 ng/mL, or Grade Group 4-5 \[Gleason score 8-10\]), and planned treatment with radical prostatectomy plus pelvic lymph node dissection (RP+PLND) or
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Adequate organ function,
  • Post-radical prostatectomy (RP): Detectable or rising serum PSA ≥0.2 ng/mL with a confirmatory serum PSA ≥0.2 ng/mL, consistent with American Urological Association (AUA) recommendations; or
  • Estimated glomerular filtration rate (eGFR \>60 mL/min/1.73 m2) calculated using the CKD EPI 2021 creatinine equation (race-neutral).80 The eGFR must be derived from a serum creatinine value measured at Screening
  • Platelets ≥ 100 × 109/L Liver function:

Exclusion

  • Participants that have been administered any high-energy (\> 300 KeV) gamma-emitting radioisotope within 5 physical half-lives, or any intravenous (IV) iodinated contrast medium within 24 hours, or any high-density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug injection.
  • Imaging evidence of metastatic disease that precludes surgical indication.
  • History of malignancy other than prostate cancer that, in the opinion of the Investigator, is expected to alter life expectancy or may interfere with study assessments, including imaging interpretation or histopathological evaluation. Participants with adequately treated nonmelanoma skin cancer, superficial bladder cancer, or other malignancies that have been disease free for more than 2 years are eligible.
  • recent myocardial infarction or arterial thrombotic events (in the past 6 months); current history of New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, or severe uncontrolled ventricular arrhythmias; or bradycardia or left ventricular ejection fraction measurement of
  • Clinical evidence or history of central nervous system metastases.

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