Expanded Access [Ga-68] PSMA-11 PET Imaging

Status:

NO_LONGER_AVAILABLE

Expanded Access [Ga-68] PSMA-11 PET Imaging

Lead Sponsor:

Mayo Clinic

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

Brief Summary

In this expanded access IND study, Mayo Clinic in Rochester MN offers \[Ga-68\] PSMA-11 PET/CT or PET/MR imaging to patients who meet criteria.

Detailed Description

\[Ga-68\] PSMA-11 PET/CT and PET/MR imaging has been shown to allow for accurate detection of metastatic prostate cancer at the time of initial diagnosis and staging of patients with high-risk prostat...

Eligibility Criteria

Inclusion

Participant Groups
There are two participant groups; please refer to the inclusion details below:
Group 1: Untreated High-Risk prostate cancer group (must meet at least one of the following inclusion criteria):
Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more
Pathologic criteria of International Society of Uropathology (ISUP) grade group 3-5 (ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10)
Local staging of T3 or worse (Indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI)
Biochemically Recurrent prostate cancer group (must meet one of the criteria):
In patients who have undergone a prostatectomy, PSA \> 0.2 ng/ml on 2 consecutive tests
In patients who have undergone definitive prostate radiation, PSA rise ≥ 2 ng/mL above the nadir PSA
Exclusion Criteria: Current exclusion criteria for both groups includes:
Patients unable to sign informed consent
Patient with a life expectancy less than 6 months
Additional exclusion criteria may be added based on demand

Exclusion

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04800068

Last Update

January 21 2022

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