Trials / Recruiting
RecruitingNCT06099093
Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan
A Pilot Study of 18F-DCFPyL-PSMA PET in Patients Receiving 177Lu-Vipivotide Tetraxetan Therapy for Metastatic Castrate-resistant Prostate Cancer
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Prostate Cancer
- Metastatic Castration-resistant Prostate Cancer
- Metastatic Castration-resistant Prostate Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 18F-DCFPyl | Fluorine-labeled small molecule, via intravenous infusion per protocol. |
Timeline
- Start date
- 2024-04-01
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2023-10-25
- Last updated
- 2026-01-29
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06099093. Inclusion in this directory is not an endorsement.