Status:
ACTIVE_NOT_RECRUITING
Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Progenics Pharmaceuticals, Inc.
Conditions:
Prostate Cancer
Prostate Neoplasm
Eligibility:
MALE
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04030338
Start Date
July 19 2019
End Date
July 1 2026
Last Update
September 3 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725