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

March 29, 2024 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-2079
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-2079
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-2079
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-2079
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-2079
      • New York, New York, United States, 10021
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-2079
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-2079

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSK) in the Department of Medical Oncology, Radiology, Radiation Oncology or Surgery. Investigators will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: 18F-DCFPyL-iPSMA
Participants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL.
Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Progenics Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Heiko Schoder, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2019

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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