Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers

May 6, 2022 updated by: Matthew Dallos, Columbia University

Primary Objective:

  • To determine whether changes in uptake of [18F]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria.

Secondary Objectives:

  • To determine whether changes in uptake of [18F]DCFPyL PET/CT scans correlate with overall survival (OS)
  • To determine whether baseline SUVmax correlate with rPFS
  • To compare number of lesions detected with standard imaging at baseline and at the time of progression

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Prostate cancer is the most common cancer and the third most common cause of cancer deaths in American men. The lethal form of the disease is metastatic castrate resistant prostate cancer (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy.

PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. However, the role of [18F] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of prostate cancer
  • Age ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
  • Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working Group 3
  • Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease
  • Ability to understand and willingness to sign a written informed consent document
  • Wiling to comply with clinical trial instructions and requirements

Exclusion Criteria:

  • History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
  • Presence of prostate brachytherapy implants
  • Administration of another radioisotope within five physical half-lives of trial enrollment
  • Radiation or chemotherapy within 2 weeks prior to trial enrollment
  • Serum creatinine > 3 times the upper limit of normal
  • Serum total bilirubin > 3 times the upper limit of normal
  • Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >5 times the upper limit of normal
  • Inadequate venous access

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PyL-PET
Male participants diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment will receive [F-18] DCFPyL PET/CT imaging before starting new treatment and after 6 weeks on treatment.
Drug: [F-18] DCFPyL
[18F]DCFPyL will be used for study imaging. It will be administered intravenously on the day of imaging. Subjects will receive a bolus injection of 9mCi (331 MBq) of [18F]DCFPyL through a peripheral IV catheter. 60 to 120 minutes after injection, a whole body (toes to vertex) lowdose CT will be obtained (120 kVp, 80 mA maximum).
Other Names:
  • [18F]DCFPyL (PyL)
Procedure: PET/CT imaging
As per standard of care, acquisition will be performed on PET/CT scanner (Siemens, Germany) operating in 3D emission mode with CT-derived attenuation correction.
Other Names:
  • PET/CT acquisition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of changes in PyL PET imaging correlating with radiographic Progression-Free Survival (rPFS)
Time Frame: Baseline, Post-treatment (approximately 6 weeks)
To determine if changes in PyL PET/CT scans before and after 6 weeks on treatment is associated with stability of disease as measured by standard imaging.
Baseline, Post-treatment (approximately 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of changes in uptake of [18F]DCFPyL PET/CT scans correlating with Overall Survival (OS)
Time Frame: Baseline, Post-treatment (approximately 6 weeks)
The percent difference in summed SUV between the first and second PET/CT will be noted.
Baseline, Post-treatment (approximately 6 weeks)
Prevalence of baseline SUVmax correlating with rPFS
Time Frame: Baseline, Post-treatment (approximately 6 weeks)
To determine if standardized uptake values (SUVs) at baseline is a good measure for patient evaluation.
Baseline, Post-treatment (approximately 6 weeks)
Change in number of lesions detected with standard imaging at baseline and at the time of progression
Time Frame: Baseline, up to 1 year
To compare lesions detected with standard imaging
Baseline, up to 1 year

Collaborators and Investigators

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

Sponsor

Columbia University

Investigators

  • Principal Investigator: Matthew C. Dallos, MD, Columbia University

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.

General Publications

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)

December 11, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

June 29, 2018

First Posted (Actual)

July 12, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR6032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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