[18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of [18F]FLOR (FC303) PET/CT imaging to determine the presence or absence of metastatic prostate cancer. .

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: FutureChem

Criteria

Inclusion Criteria:

• Males ≥18 years of age.

• Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.

• Histologically confirmed adenocarcinoma of the prostate.

• Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, or MRI), or whole-body bone scan within 4 weeks of Day 1.

• At least 2 weeks must have elapsed between last anti-cancer treatment administration and the imaging day. Imaging day will be scheduled before initiation of new systemic therapy for recurrent and/or progressive metastatic disease

• Screening clinical laboratory values within normal limits or judged not clinically significant by the investigator.

Exclusion Criteria:

• Subjects administered any radioisotope within five physical half-lives prior to study drug injection.

• Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.