Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer
Recruiting at 8 trial locations
HS
DM
Overseen ByDeaglan McHugh, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
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.
Research Team
HS
Heiko Schoder, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
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
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Imaging
Participants undergo PSMA PET scans to assess prostate cancer imaging
Duration not specified
Follow-up
Participants are monitored for safety and effectiveness after imaging
4 weeks
Treatment Details
Interventions
- 18F-DCFPyL-iPSMA
- 68Ga-HBED-iPSMA
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Prostate cancerExperimental Treatment3 Interventions
Participants with histologically confirmed prostate cancer, that is either newly diagnosed OR progressive as defined by standard PCWG3 criteria. Patients w ill remain on study until 30 days after their last PSMA imaging timepoint required by their companion therapeutic protocol.
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Trials
1,998
Recruited
602,000+
Progenics Pharmaceuticals, Inc.
Industry Sponsor
Trials
35
Recruited
4,400+
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