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408 Participants NeededMy employer runs this trial

[68Ga]-LNTH-2401 for Prostate Cancer

(SPARROW Trial)

EB
Overseen ByEryn Bagley
Age: 18+
Sex: Male
Trial Phase: Phase 2 & 3
Sponsor: Lantheus Medical Imaging
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for men recently diagnosed with prostate cancer who are considered high risk or may have cancer that has spread. They must be eligible for surgery to remove the prostate and nearby lymph nodes.

Inclusion Criteria

Must be able and willing to comply with all study requirements, treatments, and timing and nature of required assessments
I agree to use two effective birth control methods during and after the study.
I have been diagnosed with prostate adenocarcinoma by lab tests.
See 7 more

Exclusion Criteria

Any medical, psychological, familial, sociological, or geographical condition that may compromise ability to comply with study requirements or result in unreliable data
Active participation in another clinical study at time of screening
Known contraindications or hypersensitivity to [68Ga]-LNTH-2401 and/or excipients
See 8 more

What Are the Treatments Tested in This Trial?

Interventions

  • [68Ga]-LNTH-2401

Trial Overview

The study is testing a new imaging agent called [68Ga]-LNTH-2401 to help detect and stage prostate cancer more accurately. The trial will first find the best dose, then check how well it works in diagnosing patients before surgery.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: [68Ga]-LNTH-2401Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lantheus Medical Imaging

Lead Sponsor

Trials
57
Recruited
4,333,000+

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