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

Last updated: January 28, 2026
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

18F-DCFPyl

Clinical Study ID

NCT06099093
23-385
  • Ages > 18
  • Male

Study Summary

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

Inclusion

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed prostate cancer.

  • Age ≥18 years.

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

-≥1 PSMA-avid lesion on 68Ga-PSMA-11 PSMA-PET performed within 120 days of studyentry (to meet eligibility for 177Lu-Vipivotide Tetraxetan therapy).

  • Ability and willingness to comply with the study procedures.

  • Participants with a prior or concurrent malignancy whose natural history ortreatment does not have the potential to interfere with the safety or efficacyassessment of the investigational agent are eligible for this trial.

  • The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reasonand because radiopharmaceutical agents used in this trial are known to beteratogenic, women of child-bearing potential and men must agree to use adequatecontraception (hormonal or barrier method of birth control; abstinence) prior tostudy entry and for 24 hours after the 18F-DCFPyL PSMA-PET scan.

  • Ability to understand and the willingness to sign a written informed consentdocument.

Exclusion

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, orcardiac arrhythmia.

  • Contraindications to PET/CT, including severe claustrophobia.

  • History of allergic reactions attributed to compounds of similar chemical orbiologic composition to 18F-DCFPyL

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

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: 18F-DCFPyl
Phase: 4
Study Start date:
April 01, 2024
Estimated Completion Date:
December 01, 2026

Study Description

This is a one-arm single-stage prospective pilot study to determine how 18F-DCFPyL PSMA-PET/CT can be used as a diagnostic test before treatment with 177Lu-vipivotide tetraxetan, which is an approved therapy for advanced prostate cancer.

The U.S. Food and Drug Administration (FDA) has approved 18F-DCFPyL as a diagnostic agent (radiotracer) option for prostate cancer, though it is not specifically approved for participants who are due to receive 177Lu-vipivotide tetraxetan therapy.

This research study involves a single PET scan using the imaging agent 18F-DCFPyL and the collection of information from medical records.

Participation in this research study is expected to last about 12 months.

It is expected that about 30 people will take part in this research study. Progenics Pharmaceuticals, Inc. is funding this research study by providing funding and the imaging agent, 18F-DCFPyL.

Connect with a study center

  • Brigham and Womens Hospital

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Brigham and Womens Hospital

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.