Impact of Fluciclovine (18F) PET (Positron Emission Tomography) on the Management of Prostate Cancer Following Negative or Equivocal PSMA (Prostate-Specific Membrane Antigen) PET Imaging at the Time of Biochemical Recurrence

Part of paid clinical trials in San Diego, California.

Sponsor
Blue Earth Diagnostics
Study ID
NCT07569926
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • fluciclovine (18F) — DRUG
    fluciclovine (18F) injection, 370 MBq (10 mCi) ± 20%, delivered as an intravenous bolus.

Study Details

The impact of fluciclovine (18F) PET on the management of participants with prostate cancer following negative or equivocal PSMA PET Imaging at the time of biochemical recurrence

Key Dates

First listed
May 6, 2026
Start date
Aug 31, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2032

Study Design

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

Arms

  • Experimental: Patients Single intravenous administration of fluciclovine (18F) for PET Scan
    Patients Single intravenous administration of fluciclovine (18F) for PET Scan

Primary Outcome Measure

Percentage of participants with any recorded Change In Management following a fluciclovine (18F) PET/CT scan. [ Time Frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California San Diego HealthSan DiegoCalifornia92103
Sherief H Gamie, MD
Emory UniversityAtlantaGeorgia30322
Ismaheel Lawal, MD
Massachusetts General HospitalBostonMassachusetts02114
Pedram Heidari, MD
Washington UniversitySt LouisMissouri63110
Ashwin Parihar, MD
Oregon Health & Science UniversityPortlandOregon97239
Nadine Mallak, MD
Urology AustinAustinTexas78759
Brian Mazzarella, MD

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By research site
University of California San Diego Health· San Diego, CAEmory University· Atlanta, GAMassachusetts General Hospital· Boston, MAWashington University· St Louis, MOOregon Health & Science University· Portland, ORUrology Austin· Austin, TX

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