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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04030338
Other study ID # 19-170
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 19, 2019
Est. completion date July 2025

Study information

Verified date May 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 58
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 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 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

Study Design


Intervention

Drug:
18F-DCFPyL-iPSMA
Participants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL.
68Ga-HBED-iPSMA
Participants will be injected intravenously with a bolus of 3-8 mCi of 68Ga-HBED-iPSMA
Diagnostic Test:
PET/CT scan
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

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (2)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure predictive accuracy of the change in PSMA PET with respect to the time to biochemical progression start of treatment to the first PSA level above 0.2 ng/ml, up to 100 months
Primary Measure predictive accuracy of the change in PSMA PET with respect to the time to metastasis Time from the start of treatment to evidence of systemic disease on bone scan or CT/MRI, up to 100 months
Primary Measure predictive accuracy of the change in PSMA PET with respect to overall survival time. Time from the start of treatment to date of death from any cause, assessed up to up to 100 months
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