Open Actively Recruiting

68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy

About

Brief Summary

This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

Primary Purpose
Diagnostic
Study Type
Interventional
Phase
Phase II/III

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Patient with biochemical progression during ADT or combination therapies including ADT who are referred for imaging evaluation (prostate specific antigen [PSA] level >= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart)
  • Patients with bone scan scheduled or performed
    • Within 30 days of the PSMA PET, without any new prostate cancer (PCa) therapy in between
    • Bone scans performed at University of California, Los Angeles (UCLA) and external institutions are eligible if Digital Imaging and Communications in Medicine (DICOM) images can be obtained, imported, and anonymized
  • Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility
  • Patients or their legal representatives must have the ability to read, understand and provide written informed consent

Exclusion Criteria:

  • Initiation of a new therapy between the PSMA PET/CT and the bone scans
  • Inability to provide written informed consent
  • Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)

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Study Stats
Protocol No.
21-000102
Category
Molecular & Medical Pharmacology
Oncology
Principal Investigator
JEREMIE CALAIS
Contact
JEREMIE CALAIS
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04928820
For detailed technical eligibility, visit ClinicalTrials.gov.