Overview

Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
0
Participant gender:
Male
Summary
This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body. To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Michigan
Treatments:
Edetic Acid
Gallium 68 PSMA-11
Criteria
Inclusion Criteria:

1. Histopathological proven prostate adenocarcinoma.

2. Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or
radiation therapy (external beam or brachytherapy).

1. Post radical prostatectomy (RP) - according to American Urological Association
(AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6
weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.

2. Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir +
greater than or equal to 2 ng/mL rise in PSA.

3. Karnofsky performance status of ≥ 50.

4. Age ≥ 18.

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

Exclusion Criteria:

1. Current investigational therapy for prostate cancer.

2. Unable to lie flat, still or tolerate a PET/CT scan.

3. Prior history of a malignancy within the last 2 years, except skin basal cell or
cutaneous superficial squamous cell carcinoma that has not metastasized, and except
superficial bladder cancer.

4. Prisoner.