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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Metastatic Prostate Cancer; Prostate Neoplasm; Prostate Adenocarcinoma; Prostate Cancer Metastatic; Prostate Cancer

Treatments: Drug: 18F-DCFPyL-iPSMA; Diagnostic Test: PET/CT scan; Drug: 68Ga-HBED-iPSMA

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04030338

19-170

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

58 participants in 1 patient group

Prostate cancer

Description:

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.

Treatment:

Diagnostic Test: PET/CT scan

Drug: 68Ga-HBED-iPSMA

Drug: 18F-DCFPyL-iPSMA