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Trial Title:
Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan
NCT ID:
NCT06099093
Condition:
Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Metastatic Castration-resistant Prostate Carcinoma
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Metastatic Castration-resistant Prostate Carcinoma
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-DCFPyl
Description:
Fluorine-labeled small molecule, via intravenous infusion per protocol.
Arm group label:
18F-DCFPYL-PSMA PET
Other name:
[F18]-Piflufolastat, Pylarify, 2-(3-{1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]- pentyl}ureido)-pentanedioic acid
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).
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Jacene, MD
Phone:
617-632-3767
Email:
hjacene@partners.org
Investigator:
Last name:
Heather Jacene, MD
Email:
Principal Investigator
Facility:
Name:
Brigham and Womens Hospital
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather A Jacene, MD
Phone:
617-632-3767
Email:
hjacene@partners.org
Investigator:
Last name:
Heather A Jacene, MD
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Brigham and Women's Hospital
Agency class:
Other
Collaborator:
Agency:
Progenics Pharmaceuticals, Inc.
Agency class:
Industry
Source:
Brigham and Women's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06099093
