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

NCT ID: NCT04348682

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Prostate Cancer

Interventions

Positron Emission Tomography (PET) Imaging

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Biochemical Recurrence Population:

• 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.

• 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).

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:

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremie Calais, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California at Los Angeles

Locations

University of California at Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

19-001868

Identifier Type: -

Identifier Source: org_study_id