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

NCT04528199 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: J19145IRB00231620
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. .

Conditions

Metastatic Prostate Cancer

Keywords

[18F]FLOR; PET/CT; prostate cancer; J19145

Outcome Measures

Primary Outcomes (1)

• Incidence of study drug emergent adverse events

  Incidence of study drug emergent adverse events will be assessed.

  Up to 10 days post-study drug dosing

Study Arms (1)

[18F]FLOR (FC303)

EXPERIMENTAL

\[18F\]FLOR (FC303) PET/CT imaging.

Drug: [18F]FLOR (FC303) Injection

Interventions

[18F]FLOR (FC303) Injection DRUG

Single dose of 10 ±1 millicurie (mCi) of \[18F\]FLOR (FC303) injection followed by the PET/CT scan.

[18F]FLOR (FC303)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• FutureChem: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Steven Rowe, M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: February 1, 2021
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

US (1)