NCT04377152

Brief Summary

This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

First QC Date

May 1, 2020

Last Update Submit

February 24, 2021

Conditions

Prostate CancerProstateProstate Adenocarcinoma

Interventions

68Gallium-PSMA-11DRUG

PSMA-11 Ga 68 Injection is a positron emitting radiopharmaceutical containing radioactive 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (PSMA-11), which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET).

Also known as: PSMA-HBED-CC
Positron Emission Tomography (PET)PROCEDURE

A PET scan is an imaging test that helps reveal how your tissues and organs are functioning using a radioactive drug (tracer) to show this activity

Also known as: PET, PET Scan

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Histopathologically confirmed or biopsy proven prostate adenocarcinoma.
  • Concern for metastatic disease in one of the following settings:
  • Initial staging with intermediate to high risk prostate cancer.
  • Biochemical recurrence after initial therapy.
  • Ability to understand a written informed consent document, and the willingness to sign it

You may not qualify if:

  • \. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Thomas Hope, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 7, 2020

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

US(1)