Serial PSMA PET Imaging in the Assessment of Treatment Response in Patients With Progressive Prostate Cancer

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic Test, Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
New Jersey
Memoral Sloan Kettering Basking Ridge
Recruiting
Basking Ridge
Memoral Sloan Kettering Monmouth
Recruiting
Middletown
Memorial Sloan Kettering Bergen
Recruiting
Montvale
New York
Memorial Sloan Kettering Commack
Recruiting
Commack
Memorial Sloan Kettering Westchester
Recruiting
Harrison
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Memorial Sloan Kettering Nassau
Recruiting
Uniondale
Contact Information
Primary
Heiko Schoder, MD
schoderh@mskcc.org
212-639-2079
Backup
Deaglan McHugh, MD
mchughd@mskcc.org
631-212-6320
Time Frame
Start Date: July 19, 2019
Estimated Completion Date: July 2024
Participants
Target number of participants: 600
Treatments
Prostate cancer
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.
Related Therapeutic Areas
Sponsors
Collaborators: Progenics Pharmaceuticals, Inc.
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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