Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04030338
• Other study ID #: 19-170
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostate Cancer Metastatic
• Prostate Neoplasm
• Prostatic Neoplasms

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

External Links

•   Memorial Sloan Kettering Cancer Center