Biochemically Recurrent Prostate CarcinomaPhase 1NCT04216134

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

A Phase 1 study testing Gallium Ga 68-labeled PSMA-11 and Positron Emission Tomography in people with Biochemically Recurrent Prostate Carcinoma, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Biochemically Recurrent Prostate Carcinoma
What is being tested?: Gallium Ga 68-labeled PSMA-11 and Positron Emission Tomography
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 19 Dec 2019to 9 Dec 2022
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

City of Hope Medical Center
Duarte, California, 91010

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

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.

Conditions: Biochemically Recurrent Prostate Carcinoma
Being tested: Gallium Ga 68-labeled PSMA-11, Positron Emission Tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gallium Ga 68-labeled PSMA-11Drug
Also called (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography Scan
Undergo 68GA-PSMA-11 PET

Study groups in NCT04216134
Study group	Role	What they receive
Diagnostic (68GA-PSMA-11 PET)	Experimental	Patients receive gallium Ga 68-labeled PSMA-11 IV over less than 1 minute, and then undergo PET over 60 minutes. Receives: Drug: Gallium Ga 68-labeled PSMA-11; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of adverse events
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 20199 Dec 2022

First posted2 Jan 2020
Study start19 Dec 2019
Primary completion9 Dec 2022
Study completion9 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Biochemically Recurrent Prostate CarcinomaStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04216134
Sponsor's protocol ID: 19517
Other IDs: NCI-2019-08625, 19517, P30CA033572
Status last verified: Oct 2026
First submitted: 30 Dec 2019
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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