Expanded Access to 68Ga-PSMA-11 PET Imaging for Prostate Cancer Detection

Sponsor: Jonsson Comprehensive Cancer Center

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04348682

Provider View

This program offers access to a special PET scan using 68Ga-PSMA-11 to help locate and assess prostate cancer, aiding in treatment planning for eligible patients.

Patient Parameters

Program Overview

The 68Ga-PSMA-11 PET scan is a new imaging method that helps doctors see prostate cancer more clearly. This scan is especially useful for diagnosing and staging prostate cancer, which can help in planning the best treatment. The University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) have conducted important studies to ensure this scan is safe and effective. While waiting for full approval, UCLA is offering this scan to eligible patients who need it.

Description

The 68Ga-PSMA-11 PET scan is a cutting-edge imaging technique that targets a specific protein found in prostate cancer cells, allowing for more accurate detection and staging of the disease. This scan has been widely accepted around the world due to its ability to provide detailed images of prostate cancer, which can significantly aid in treatment decisions. UCLA and UCSF have been at the forefront of researching this technology, conducting trials to confirm its safety and effectiveness. To meet the needs of patients before the scan receives full approval, UCLA is providing access to this investigational PET scan for those who qualify.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of prostate cancer.
  • Rising PSA levels after surgery or radiation treatment for prostate cancer.
    • After surgery, PSA must be 0.2 ng/mL or higher, measured more than 6 weeks post-surgery.
    • After radiation, PSA must rise by 2 ng/mL or more from the lowest level.
  • Able to perform daily activities with some help (Karnofsky score of 50 or higher).
  • Must be 18 years or older.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Currently receiving another experimental treatment.
  • Unable to lie flat, stay still, or tolerate a PET scan.
  • Receiving treatment for another type of cancer, except for certain skin cancers that haven't spread or superficial bladder cancer.

For those being staged before prostate surgery:

Inclusion criteria:

  • Biopsy-confirmed prostate cancer.
  • Considering surgery with lymph node removal.
  • Intermediate to high-risk cancer based on PSA levels, tumor stage, or Gleason score.
  • Able to provide written consent.
  • Able to perform daily activities with some help (Karnofsky score of 50 or higher).

Exclusion criteria:

  • Unable to undergo a PET scan due to weight, fear of enclosed spaces, or inability to stay still.
  • Received chemotherapy, radiation, or other local treatments before surgery.

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