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

Running, not enrolling

Conditions studied: Prostate Cancer, Prostate Neoplasm, Prostate Adenocarcinoma, Prostate Cancer Metastatic, Metastatic Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04030338

Run by

Memorial Sloan Kettering Cancer Center

People needed

58

Starts

2019-07-19

Expected to finish

2027-07-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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