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68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase I Study of 68GA-PSMA-11 PET Imaging for Biochemically Recurrent Prostate Cancer

NCT04216134•City of Hope Medical Center

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

Age

18 - No limit years

Sex

MALE

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

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Key Dates

Start Date

December 12, 2019

Primary Completion Date

December 9, 2022

Completion Date

December 9, 2022

Last Updated

June 15, 2023

Enrollment

ACTUAL participants

Conditions

Biochemically Recurrent Prostate Carcinoma

Interventions

Gallium Ga 68-labeled PSMA-11

DRUG

Positron Emission Tomography

PROCEDURE

Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer

NCT07073794

Biochemically Recurrent Prostate CarcinomaLocally Advanced Prostate Carcinoma+3 more

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RECRUITINGPHASE3

SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma

NCT06205316

Biochemically Recurrent Prostate CarcinomaOligometastatic Prostate Carcinoma+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer

SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma

Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring

An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer

68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy