search
Back to results

Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer

Primary Purpose

Prostate Adenocarcinoma

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
68Ga-PSMA-11
Sponsored by
Morand Piert, MD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Prostate Adenocarcinoma focused on measuring Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Male

Inclusion Criteria:

  • Histopathological proven prostate adenocarcinoma
  • Elevated PSA after initial therapy: Post radical prostatectomy (RP) - AUA recommendation. PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL
  • Elevated PSA after initial therapy: Post radiation therapy or post focal therapy of prostate gland. Nadir + greater than or equal to 2 ng/mL rise in PSA
  • Ability to understand a written informed consent document and the willingness to sign it

Exclusion Criteria:

  • Current investigational therapy for prostate cancer
  • Unable to lie flat, still, or tolerate a PET/CT scan

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 2, 2022
    Last Updated
    May 17, 2023
    Sponsor
    Morand Piert, MD
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05415228
    Brief Title
    Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
    Official Title
    Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Morand Piert, MD

    4. Oversight

    5. Study Description

    Brief Summary
    This is an expanded access program using 68Ga PSMA-HBED-CC (68Ga-PSMA-11). The primary goal of this expanded access program is to make 68Ga PSMA-11 PET/CT imaging available to patients.
    Detailed Description
    Imaging and staging of prostate cancer is critical for surgical and treatment planning. Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) has recently been approved by the FDA for clinical use in a formulation utilized at the University of California in Los Angeles UCLA) and San Francisco (UCSF). The production process for 68Ga-PSMA-11 at the University of Michigan (UM) is different and not FDA approved. This expanded access program was established to allow a continued use of 68Ga-PSMA-11 produced at the University of Michigan for clinical management for prostate cancer at the University of Michigan.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Adenocarcinoma
    Keywords
    Prostate Cancer

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    68Ga-PSMA-11
    Other Intervention Name(s)
    HBED-CC, Glu-urea-Lys(Ahx)-HBED-CC, PSMA-HBED-CC
    Intervention Description
    68Ga-PSMA-11 is a radiopharmaceutical for the detection of prostate cancer using PET/CT imaging

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Histopathological proven prostate adenocarcinoma Elevated PSA after initial therapy: Post radical prostatectomy (RP) - AUA recommendation. PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL Elevated PSA after initial therapy: Post radiation therapy or post focal therapy of prostate gland. Nadir + greater than or equal to 2 ng/mL rise in PSA Ability to understand a written informed consent document and the willingness to sign it Exclusion Criteria: Current investigational therapy for prostate cancer Unable to lie flat, still, or tolerate a PET/CT scan

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34326126
    Citation
    Abghari-Gerst M, Armstrong WR, Nguyen K, Calais J, Czernin J, Lin D, Jariwala N, Rodnick M, Hope TA, Hearn J, Montgomery JS, Alva A, Reichert ZR, Spratt DE, Johnson TD, Scott PJH, Piert M. A Comprehensive Assessment of 68Ga-PSMA-11 PET in Biochemically Recurrent Prostate Cancer: Results from a Prospective Multicenter Study on 2,005 Patients. J Nucl Med. 2022 Apr;63(4):567-572. doi: 10.2967/jnumed.121.262412. Epub 2021 Jul 29.
    Results Reference
    result

    Learn more about this trial

    Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer

    We'll reach out to this number within 24 hrs