Clinical trial NCT04216134: 68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer
Official title: A Phase I Study of 68GA-PSMA-11 PET Imaging for Biochemically Recurrent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Biochemically Recurrent Prostate Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-01-02
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Maria Parayno
role: PRINCIPAL_INVESTIGATOR
References: