Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer

• Conditions: Prostate Cancer; Prostate; Prostate Adenocarcinoma

• Registration Number: NCT04377152
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥ 18 years

2. Histopathologically confirmed or biopsy proven prostate adenocarcinoma.

3. Concern for metastatic disease in one of the following settings:

   1. Initial staging with intermediate to high risk prostate cancer.
   2. Biochemical recurrence after initial therapy.

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States