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

  • STATUS
    Recruiting
  • End date
    Jul 27, 2022
  • participants needed
    600
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 27 January 2021
ct scan
cancer
karnofsky performance status
endocrine therapy
progressive disease
hormone therapy
bone scan
metastatic prostate cancer
positron emission tomography
pet/ct scan
prostate cancer metastatic

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.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Adenocarcinoma, Adenocarcinoma of the Prostate, Adenocarcinoma of Prostate, Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, prostate carcinoma, prostate neoplasm, prostate tumor, prostate tumors, prostate cancers
Treatment PET/CT scan, 18F-DCFPyL-iPSMA, 68Ga-HBED-iPSMA
Clinical Study IdentifierNCT04030338
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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
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