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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Lantheus Medical Imaging
Study ID
NCT07831824
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
408 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [68Ga]-LNTH-2401
    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.

Primary Outcome Measure

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 [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
BAMF HealthGrand RapidsMichigan49503
Harshad Kulkarni, MD
[email protected]

Find similar trials in Grand Rapids, MI

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By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
BAMF Health· Grand Rapids, MI

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