Status:
APPROVED_FOR_MARKETING
Expanded Access Protocol of 68Ga-PSMA-11 for PET Imaging
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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).
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04348682
Last Update
June 24 2021
Active Locations (1)
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1
University of California at Los Angeles
Los Angeles, California, United States, 90095