Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06062745
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Prostate Cancer
  • Metastatic Prostate Cancer
  • Metastatic Prostate Neuroendocrine Carcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 18F-fluciclovine — DRUG
    18F-fluciclovine is a radiotracer targeting amino-acid transporters.Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance to make images of processes that are happening in the body
  • PET/CT — DEVICE
    Positron emission tomography/computed tomography (PET/CT) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions.

Study Details

This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features. The name of the study interventions are: * 18F-fluciclovine-PET/CT scan * Two research blood collections

Key Dates

Start date
Feb 1, 2024
Status verified
Nov 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 18F-fluciclovine
    Participants with low prostate-specific membrane antigen (PSMA) expression or neuroendocrine prostate cancer will receive: * 18F-fluciclovine PET/CT within 6 weeks of standard of care exam and 68Ga-PSMA PET/CT * 2x Blood test at time of 18F-fluciclovine PET/CT and prior to treatment as determined by participants primary oncologist

Primary Outcome Measure

Fluciclovine and PSMA Uptake in PSMA Positive Tumors [ Time Frame: Up to 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Womens HospitalBostonMassachusetts02215
Heather A Jacene, MD
[email protected]
617-632-3767
Heather A Jacene, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Heather Jacene, MD
[email protected]
617-632-3767
Heather Jacene, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Womens Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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