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

NCT07831824 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RM2-3301
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Suspected Metastatic Disease; Newly Diagnosed Prostate cancer

Outcome Measures

Primary Outcomes (6)

• Phase 2 Dose Optimization Period: Optimal administered activity (radioactivity) and imaging time window for [68Ga]-LNTH-2401 PET/CT based on image quality and interpretability in participants with either newly diagnosed or BCR PCa

  Image quality scores (IQS) for administered activity (radioactivity) for \[68Ga\]-LNTH-2401 PET/CT

  Day 1

• Phase 2 Dose Optimization Period : Optimal administered activity (radioactivity) and imaging time window for [68Ga]-LNTH-2401 PET/CT based on image quality and interpretability in participants with either newly diagnosed or BCR PCa

  Image quality scores (IQS) for imaging time windows for \[68Ga\]-LNTH-2401 PET/CT

  Day 1

• Phase 2 Dose Optimization Period :Biodistribution and radiation dosimetry of [68Ga]-LNTH-2401 in participants with either newly diagnosed or BCR PCa.

  Time activity curves (TACs), describing the percentage of the injected activity versus time will be derived for standard organs. Absorbed radiation doses of \[68Ga\]-LNTH-2401in standard organs; whole-body effective dose will also be estimated.

  Day 1

• Safety and tolerability of [68Ga] LNTH 2401 in participants with either newly diagnosed or BCR PCa.

  Frequency and severity of AEs per CTCAE version 6.0 for \[68Ga\]-LNTH-2401.

  1 week (Ph2), 6 months (Ph3)

• Safety and tolerability of [68Ga] LNTH 2401 in participants with either newly diagnosed or BCR PCa.

  Clinical laboratory parameters (e.g., hematology, chemistry), vital signs, and ECG parameters after administration of \[68Ga\]-LNTH 2401.

  1 week (Ph2), 6 months (Ph3)

• Phase 3 Diagnostic Performance Period- Diagnostic accuracy (sensitivity and specificity) of [68Ga]-LNTH-2401 PET/CT imaging for detecting prostate cancer in pelvic lymph nodes, compared to histopathology.

  Co-primary endpoints of: Participant-level specificity (TN/\[TN + FP\]) of \[68Ga\]-LNTH-2401 PET/CT for detection of prostate cancer in pelvic lymph nodes relative to histopathology. Participant-level sensitivity (TP/\[TP + FN\]) of \[68Ga\]-LNTH-2401 PET/CT for detection of prostate cancer in pelvic lymph nodes relative to histopathology.

  Enrollment through study completion, average 6 months

Secondary Outcomes (6)

• Phase 2 Dose Optimization Period- Refine the GRPR positivity definition

  Day 1

• Phase 3 Diagnostic Performance Period- Evaluation of the safety and tolerability of [68Ga]-LNTH-2401.

  From Enrollment to End of treatment of Ph3

• Phase 3 Diagnostic Performance Period- Determination of (true) detection rates of [68Ga]-LNTH-2401 and conventional imaging (CT/MRI of pelvis, ultrasound, bone scan) or PSMA PET/CT or PET/MRI among anatomic regions

  From Enrollment to End of treatment of Ph3

• Phase 3 Diagnostic Performance Period- Assessment of the diagnostic performance of [68Ga]-LNTH-2401 PET/CT imaging of prostate cancer within the prostatic region.

  From Enrollment to End of treatment of Ph3

• Phase 3 Diagnostic Performance Period- To determine the patient level and region level diagnostic performance of [68Ga] LNTH-2401 PET/CT imaging prostate cancer within the pelvic lymph nodes or other metastatic lesions.

  From Enrollment to End of treatment of Ph3

Study Arms (1)

[68Ga]-LNTH-2401

EXPERIMENTAL

Phase 2 period, \[68Ga\]-LNTH-2401 will be administered at 5 (±1) mCi (148 to 222 MBq). Phase 3 period, the intended commercial-use manufactured \[68Ga\]-LNTH 2401 product will be administered for imaging at the optimized dose selected from the Phase 2 period.

Drug: [68Ga]-LNTH-2401

Interventions

[68Ga]-LNTH-2401 DRUG

\[68Ga\]-LNTH-2401 will be administered to identify newly diagnosed prostate cancer.

[68Ga]-LNTH-2401

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the criteria below as defined to be enrolled in the study.
• Participants must be male and ≥18 years old or defined as adults per applicable local laws and regulations, at the time of signing the informed consent.
• Participants who are sexually active must agree to the following during the study and for 7 days after last administration of study drug:
• Use 2 highly effective contraceptive methods when engaging in sexual intercourse with partners who are pregnant or of childbearing potential (Appendix 2).
• Refrain from donating sperm.
• Participants who are claustrophobic must be willing to take an anti-anxiety medication prescribed by their physician one hour prior to the scan.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Adequate organ function,
• Adequate organ function, defined as follows:
• Bone marrow reserve:
• White blood cell count ≥ 2.5 × 109/L OR absolute neutrophil count (ANC) ≥ 1.5 × 109/L
• Platelets ≥ 100 × 109/L
• Platelets ≥ 100 × 109/L
• Liver function:
• Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN). For participants with known Gilbert's syndrome, ≤ 3 × ULN is permitted.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN

You may not qualify if:

• 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.
• Participants are excluded if they have received any other prior anti-cancer therapy (including radioligand therapy) or investigational agent within ≤28 days (or 5 half-lives, whichever is shorter) prior to the first dose of study treatment. Note: Prior external beam radiation therapy (EBRT) is permitted for Phase 2 participants with BCR PCa only.
• Participants who are planning to undergo alternate medical procedures for prostate cancer from the time of dosing (Day 1) to surgery.
• 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.
• Any medical, psychological, familial, sociological, or geographical condition that, in the opinion of the Investigator, may compromise the participant's ability to comply with study requirements, undergo study procedures, or result in the collection of reliable data.
• Active participation in another clinical study at the time of screening for this study.
• Known contraindications or hypersensitivity to \[68Ga\]-LNTH-2401 and/or excipients.
• Clinical evidence or history of central nervous system metastases.
• Clinically significant cardiovascular disease, that in the opinion of the Investigator may pose an unacceptable risk to the participant or interfere with study assessments. This includes any of the following:
• 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
• history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, congenital long QT syndrome, and/or familial history of prolonged QT syndrome) or taking medication known to cause QT/QTc prolongation; or marked baseline prolongation of the QT/QTc interval (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \>450 ms).
• Treatment-related adverse events from prior or concurrent therapies that have not resolved to grade ≤1 according to the CTCAE Version 6.0.
• Imaging evidence of metastatic disease that precludes surgical indication.

Sponsors & Collaborators

• Lantheus Medical Imaging: lead

Study Sites (1)

BAMF Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Eryn Bagley

CONTACT

978-671-8886; clinicaltrials@lantheus.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 21, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

US (1)