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An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

68Ga-PSMA-11 PET in Patients With Prostate Cancer

NCT04777071•University of Washington

Summary

This trial studies how well 68Ga-PSMA-11 PET scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET may find and diagnose prostate cancer and improve monitoring of treatment response.

Detailed Description

OUTLINE: Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 60-75 minutes then undergo PET/CT or PET/magnetic resonance (MR) scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study. After the completion of study, patients are followed up at 60 days, 6 months, and annually up to 5 years or until time of first progression.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Pathologically proven prostate adenocarcinoma
•For the initial staging arm (initial staging cohort), high risk characteristics, including any of the following:
•* Grade group 4-5 and/or
•* PSA \> 20 ng/mL
•For patients with biochemical recurrence (biochemical recurrence cohort):
•* Rising PSA after definitive therapy with prostatectomy or targeted local therapy (including but not limited to external beam radiation therapy, brachytherapy, high-frequency ultrasound, and cryotherapy)
•* If post-radical prostatectomy, PSA \> 0.2 ng/mL measured \> 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association (AUA) definition for biochemical recurrence
•* If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society of Radiation Oncology (ASTRO) definition for biochemical recurrence)
•For patients undergoing systemic therapy (treatment monitoring cohort):
•* Diagnosis of metastatic castration-resistant prostate cancer
+6 more criteria

Exclusion Criteria

•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Key Dates

Start Date

May 17, 2021

Primary Completion Date

July 15, 2025

Completion Date

July 15, 2030

Last Updated

January 9, 2026

Enrollment

141

ACTUAL participants

Conditions

Biochemically Recurrent Prostate CarcinomaMetastatic Castration-Resistant Prostate CarcinomaProstate AdenocarcinomaStage IIC Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8

Interventions

Computed Tomography

PROCEDURE

Gallium Ga 68 Gozetotide

DRUG

Positron Emission Tomography

PROCEDURE

Magnetic Resonance Imaging

PROCEDURE

Bone Scan

PROCEDURE

Electronic Health Record Review

OTHER

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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: January 9, 2026Data 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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An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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

Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) With Prostate Cancer (CaP)

SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma

Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study