Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT06099093
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Metastatic Castration-resistant Prostate Cancer
- Metastatic Castration-resistant Prostate Carcinoma
- Prostate Cancer
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 18F-DCFPyl — DRUGFluorine-labeled small molecule, via intravenous infusion per protocol.
Study Details
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).
Key Dates
- Start date
- Apr 1, 2024
- Status verified
- Nov 2025
- Primary completion
- Dec 1, 2026
- Completion
- Dec 1, 2026
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: 18F-DCFPYL-PSMA PETStudy 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.
Primary Outcome Measure
Proportion of Participants with PSMA-Positive Lesion [ Time Frame: 1 Day ]
Central Contacts
- Heather Jacene, MD617-632-3767
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Womens Hospital | Boston | Massachusetts | 02215 | Heather A Jacene, MD (PRINCIPAL_INVESTIGATOR) |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | Heather Jacene, MD (PRINCIPAL_INVESTIGATOR) |
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