TheranosticTrials.org

Clinical Trial · NCT06099093

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

Overview

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).

Sponsor

Unknown Organization

Phase

Phase 4

Contacts

Heather Jacene, MD (PRINCIPAL_INVESTIGATOR)

Heather Jacene, MD (CONTACT)

hjacene@partners.org

617-632-3767

ClinicalTrials.gov

NCT06099093

Drug / Compound

vipivotide tetraxetan

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

DCFPyL

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

  • Participants must have histologically or cytologically confirmed prostate cancer.
  • The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason and because radiopharmaceutical agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 24 hours after the 18F-DCFPyL PSMA-PET scan.
  • Ability and willingness to comply with the study procedures.
  • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent are eligible for this trial.
  • Participants must be planned for standard-of-care 177Lu-Vipivotide Tetraxetan therapy after the 18F-DCFPyL PSMA-PET. -≥1 PSMA-avid lesion on 68Ga-PSMA-11 PSMA-PET performed within 120 days of study entry (to meet eligibility for 177Lu-Vipivotide Tetraxetan therapy).

Exclusion

  • Contraindications to PET/CT, including severe claustrophobia.
  • 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.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.