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Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer

Serial PSMA PET Imaging in the Assessment of Treatment Response in Patients With Progressive Prostate Cancer

NCT04030338•Memorial Sloan Kettering Cancer Center

Summary

The purpose of this study is to determine if Prostate-Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans used in this study accurate and better at imaging participants' prostate cancer than the usual methods.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patients with histologically confirmed prostate cancer, that is either: newly diagnosed OR progressive as defined by standard PCWG3 criteria. note that metastatic disease is defined by either bone scintigraphy or by CT or MRI, or a combination of these tests, but not exclusively by molecular imaging criteria.
•Patients with newly diagnosed localized or metastatic prostate cancer are eligible, provided standard imaging (either bone scintigraphy, CT or MRI) demonstrates evidence of radiographic disease
•Patient with progressive disease that is non-metastatic are eligible by biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart
•Patients with progressive disease that is metastatic are eligible either by biochemical progression or radiographic progression or both
•Patients are permitted to have had up to 2 months of prior hormonal therapy before entering this trial (and many therapeutic trials) and therefore, their progression criteria would apply to their pre-treatment imaging and PSA parameters Note: This criterion pertains to patients with newly diagnosed, untreated disease. This criterion does not apply to those who were already on therapy for metastatic CRPC.
•Karnofsky performance status of \>/= 50 (or ECOG/WHO equivalent)
•Male (or transgender female) \> 18 years of age
•Patient must be able to understand and willing to sign a written informed consent document
•Patient is anticipating starting a therapeutic strategy following imaging

Exclusion Criteria

•Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and non-invasive bladder cancer
•Unable to lie flat, still or tolerate a PET scan

Locations (7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Key Dates

Start Date

July 19, 2019

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

September 3, 2025

Enrollment

ACTUAL participants

Conditions

Prostate CancerProstate NeoplasmProstate AdenocarcinomaProstate Cancer MetastaticMetastatic Prostate Cancer

Interventions

18F-DCFPyL-iPSMA

DRUG

68Ga-HBED-iPSMA

DRUG

PET/CT scan

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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: September 3, 2025Data 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.

View ClinicalTrials.gov Terms and Conditions

Prostate-Specific Membrane Antigen (PSMA) PET Scans in People 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

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC