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

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06099093
Collaborator
Progenics Pharmaceuticals, Inc. (Industry)
30
Enrollment
2
Locations
1
Arm
20
Anticipated Duration (Months)
15
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Pilot Study of 18F-DCFPyL-PSMA PET in Patients Receiving 177Lu-Vipivotide Tetraxetan Therapy for Metastatic Castrate-resistant Prostate Cancer
Anticipated Study Start Date :
Apr 1, 2024
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 18F-DCFPYL-PSMA PET

Study procedures will be conducted as follows: Baseline screening visit with PSMA-PET/CT scan with Ga-PSMA-11. In-clinic visit with exam and PSMA-PET/CT scan with 18F-DCFPyl per standard institutional procedures. Standard of care therapy. Follow up every 3 months via chart review for 12 months, with the purpose of seeing how participants respond to 177Luvipivotide tetraxetan treatment.

Drug: 18F-DCFPyl
Fluorine-labeled small molecule, via intravenous infusion per protocol.
Other Names:
  • [F18]-Piflufolastat, Pylarify, 2-(3-{1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]- pentyl}ureido)-pentanedioic acid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants with PSMA-Positive Lesion [1 Day]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    -≥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).

    • 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.

    • 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 to understand and the willingness to sign a written informed consent document.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dana Farber Cancer Institute Boston Massachusetts United States 02115
    2 Brigham and Womens Hospital Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Dana-Farber Cancer Institute
    • Progenics Pharmaceuticals, Inc.

    Investigators

    • Principal Investigator: Heather Jacene, MD, Dana-Farber Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heather A. Jacene, MD, Principal Investigator, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT06099093
    Other Study ID Numbers:
    • 23-385
    First Posted:
    Oct 25, 2023
    Last Update Posted:
    Oct 25, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Heather A. Jacene, MD, Principal Investigator, Dana-Farber Cancer Institute
    Prostate Cancer
    Metastatic Castration-resistant Prostate Cancer
    Metastatic Castration-resistant Prostate Carcinoma
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Oct 25, 2023