Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorBrigham and Women's Hospital

About this trial

The purpose of this research study is to see how well an imaging test, called 18FDCFPyL prostate specific membrane antigen (PSMA) positron emission tomography (PET), can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PET/CT (another type of diagnostic scan for prostate cancer).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically or cytologically confirmed prostate cancer.

Age ≥18 years.

Participants must be planned for standard-of-care 177Lu-Vipivotide Tetraxetan therapy after the 18F-DCFPyL PSMA-PET.

Ability and willingness to comply with the study procedures.

Disqualifiers

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.

Contraindications to PET/CT, including severe claustrophobia.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL

Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • 18F-DCFPyl

    Drug

    Fluorine-labeled small molecule, via intravenous infusion per protocol.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: 18F-DCFPYL-PSMA PETExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Participants with PSMA-Positive Lesion

Defined as the number of participants with at least 1 PSMA-positive lesion on 18F-DCFPyL PSMA-PET.

Time frame
1 Day

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Progenics Pharmaceuticals, Inc.

Collaborator