68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer

City of Hope

Status and phase

Completed

Phase 1

Conditions

Biochemically Recurrent Prostate Carcinoma

Treatments

Drug: Gallium Ga 68-labeled PSMA-11

Procedure: Positron Emission Tomography

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04216134

NCI-2019-08625 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

19517

Details and patient eligibility

About

This phase I trial studies the side effects of 68GA-PSMA-11 PET imaging in patients with prostate cancer that has come back (recurrent). Gallium (68Ga) is a radiotracer that binds to a molecule, PSMA, that is found in abundance on most prostate cancer cells. PSMA is short for 'prostate specific membrane antigen'. Diagnostic procedures, such as 68GA-PSMA-11 PET imaging, may help measure a patient's response to earlier treatment, and may help plan the best treatment for prostate cancer.

Full description

PRIMARY OBJECTIVE:

I. To provide clinical access to and assess the safety of the investigational agent Gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA-11) positron emission tomography (PET) at City of Hope National Medical Center for patients co-enrolled on Institutional Review Board (IRB) 18517 treatment trial.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over less than 1 minute, and then undergo PET over 60 minutes.

After completion of study, patients are followed up at 1-3 days, and then at 3 weeks.

Enrollment

19 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Biochemical recurrent prostate cancer
Karnofsky performance status of >= 50
The effects of 68Ga-PSMA-11 on the developing fetus are unknown. For this reason, subjects must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation when having sex with a pregnant female or with a female partner of childbearing potential
Co-enrollment on IRB 18517
Documented informed consent of the patient. All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion criteria

Patients should not have any uncontrolled illness including ongoing or active infection
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA-11
Use of another concomitant investigational therapy (with the exception of the investigational treatment given in IRB 18517) for prostate cancer within 7 days of scheduled 68Ga-PSMA-11 PET scan
Unable to tolerate PET scan (i.e. if the patient is claustrophobic or unable to lie still for 30-60 minutes)
Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study