A Phase 4 interventional study of 18F-DCFPyl in Prostate Cancer, Metastatic Castration-resistant Prostate Cancer and Metastatic Castration-resistant Prostate Carcinoma, sponsored by Brigham and Women's Hospital. Recruiting at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Diagnostic
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).
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 30 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 Criteria:
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.
Also known as: [F18]-Piflufolastat, Pylarify, 2-(3-{1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]- pentyl}ureido)-pentanedioic acid
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
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap
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