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

Johns Hopkins Medicine

Status and phase

Terminated

Phase 1

Conditions

Metastatic Prostate Cancer

Treatments

Drug: [18F]FLOR (FC303) Injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04528199

IRB00231620 (Other Identifier)

J19145

Details and patient eligibility

About

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. .

Full description

This research is being done to determine whether the radioactive compound called [18F]FLOR (FC303) is safe and well-tolerated in patients with metastatic prostate cancer.

Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include up to three clinic visits.

Eligible patients diagnosed with metastatic prostate cancer will undergo a [18F]FLOR (FC303) PET-CT scan. This is the imaging procedure to assess where [18F]FLOR (FC303) has accumulated in the body.

Enrollment

8 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.