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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT04348682
• Other study ID #: 19-001868
• Status: Approved for marketing

Study information

• Verified date: June 2021
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	University of California at Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States,