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Expanded Access Protocol of 68Ga-PSMA-11 for PET Imaging

Primary Purpose

Prostate Cancer

Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Positron Emission Tomography (PET) Imaging
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Prostate Cancer focused on measuring prostate, imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Male

Biochemical recurrent (i. Inclusion/Exclusion) and preprostatectomy (ii. Inclusion/Exclusion) staging patients will be eligible for the expanded access protocol. In order to be eligible to participate in this study, an individual must meet the following criteria:

Biochemical Recurrence Population:

i. Inclusion Criteria:

  • Histopathological proven prostate adenocarcinoma.

  • Rising prostatic specific antigen(PSA) after definitive therapy with prostatectomy or radiation therapy.

    • Post radical prostatectomy (RP)
    • PSA equals to or greater than 0.2 ng/mL measured more than 6weeks after RP
    • Post-radiation therapy -ASTRO-Phoenix consensus definition
    • Nadir + greater than or equal to 2 ng/mL rise in PSA
  • Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/ World Health Organization (WHO) equivalent).
  • Age > 18.

  • Ability to understand a written informed consent document, and the willingness to sign it.

    i. Exclusion Criteria:

  • Concomitant investigational therapy.
  • Known inability to lie flat, remain still or tolerate a PET scan.
  • Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Preprostatectomy Staging Population:

ii. Inclusion criteria:

  • Biopsy proven prostate adenocarcinoma.
  • Considered for prostatectomy with lymph node dissection.
  • Intermediate to high-risk disease (as determined by elevated PSA [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors).
  • Able to provide written consent.
  • Karnofsky performance status of ≥50 (or ECOG/WHO equivalent).

ii. Exclusion criteria:

  • Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
  • Neoadjuvant chemotherapy, radiation therapy or any definitive local therapy prior to prostatectomy including focal ablation techniques (HiFu).

Sites / Locations

  • University of California at Los Angeles

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 13, 2020
Last Updated
June 21, 2021
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04348682
Brief Title
Expanded Access Protocol of 68Ga-PSMA-11 for PET Imaging
Official Title
Expanded Access Protocol of 68Ga-PSMA-11 for Prostate Cancer PET Imaging
Study Type
Expanded Access

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

5. Study Description

Brief Summary
To provide expanded access to 68Ga-PSMA-11 PET imaging for eligible participants to detect and localize prostate cancer for initial and subsequent treatment strategy.
Detailed Description
Prostate-specific membrane antigen (PSMA) targeted Positron Emission Tomography (PET) imaging has been embraced enthusiastically worldwide. Given the unmet clinical need for accurately diagnosing and staging prostate cancer and the encouraging results of 68Ga-PSMA-11 PET worldwide, University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) conducted pivotal registration trials to assess 68Ga-PSMA-11's safety and efficacy profile in detecting prostate cancer in adult patients. To gap the unmet clinical need of 68Ga-PSMA-11 PET during the period prior to FDA approval, UCLA Nuclear Medicine offers expanded access of this investigational PET drug to eligible participants.

6. Conditions and Keywords

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

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Positron Emission Tomography (PET) Imaging
Intervention Description
A single dose activity of 5 mCi (accepted range of 3-7 mCi) of 68Ga-PSMA-11 will be intravenously administered to patient as a bolus injection. After 50-100 minutes of uptake time, the patient will undergo a whole body (skull to mid-thighs) PET/CT imaging.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participation is not based on self-representation. Participation is based on the possession of a prostate gland.
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Biochemical recurrent (i. Inclusion/Exclusion) and preprostatectomy (ii. Inclusion/Exclusion) staging patients will be eligible for the expanded access protocol. In order to be eligible to participate in this study, an individual must meet the following criteria: Biochemical Recurrence Population: i. Inclusion Criteria: Histopathological proven prostate adenocarcinoma. Rising prostatic specific antigen(PSA) after definitive therapy with prostatectomy or radiation therapy. Post radical prostatectomy (RP) PSA equals to or greater than 0.2 ng/mL measured more than 6weeks after RP Post-radiation therapy -ASTRO-Phoenix consensus definition Nadir + greater than or equal to 2 ng/mL rise in PSA Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/ World Health Organization (WHO) equivalent). Age > 18. Ability to understand a written informed consent document, and the willingness to sign it. i. Exclusion Criteria: Concomitant investigational therapy. Known inability to lie flat, remain still or tolerate a PET scan. Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer. Preprostatectomy Staging Population: ii. Inclusion criteria: Biopsy proven prostate adenocarcinoma. Considered for prostatectomy with lymph node dissection. Intermediate to high-risk disease (as determined by elevated PSA [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors). Able to provide written consent. Karnofsky performance status of ≥50 (or ECOG/WHO equivalent). ii. Exclusion criteria: Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam. Neoadjuvant chemotherapy, radiation therapy or any definitive local therapy prior to prostatectomy including focal ablation techniques (HiFu).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremie Calais, M.D.
Organizational Affiliation
University of California at Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Expanded Access Protocol of 68Ga-PSMA-11 for PET Imaging

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