18F-DCFPyL-iPSMA
DrugParticipants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL.
NCT Number: NCT04030338
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Male
Observational
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion 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.
Exclusion criteria
Participants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL.
Participants will be injected intravenously with a bolus of 3-8 mCi of 68Ga-HBED-iPSMA
The baseline PSMA PET scan may be performed externally or at MSKCC, but all follow-up imaging must be performed at MSKCC. Approximately 60-90 minutes after intravenous injection of radiotracer, patients will be scanned from the mid-skull to the mid-thigh. Imaging will start with a low-dose CT for attenuation correction, followed by a PET scan. Upon completion of imaging and at the discretion of the investigator, the patient may be asked to void and get back in the scanner for 1 additional image of the pelvis.This additional image allows investigator's to see an unobstructed view of the prostate/prostate bed
Time frame: start of treatment to the first PSA level above 0.2 ng/ml, up to 100 months
Time frame: Time from the start of treatment to evidence of systemic disease on bone scan or CT/MRI, up to 100 months
Time frame: Time from the start of treatment to date of death from any cause, assessed up to up to 100 months
Memorial Sloan Kettering Cancer Center
Other
Serial PSMA PET Imaging in the Assessment of Treatment Response in Patients With Progressive Prostate Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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