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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-19

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer Prostate Neoplasm Prostate Adenocarcinoma Prostate Cancer Metastatic Metastatic Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

18F-DCFPyL-iPSMA

Intervention Type DRUG

Participants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL.

68Ga-HBED-iPSMA

Intervention Type DRUG

Participants will be injected intravenously with a bolus of 3-8 mCi of 68Ga-HBED-iPSMA

PET/CT scan

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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18F-DCFPyL-iPSMA

Participants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL.

Intervention Type DRUG

68Ga-HBED-iPSMA

Participants will be injected intravenously with a bolus of 3-8 mCi of 68Ga-HBED-iPSMA

Intervention Type DRUG

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No