18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer

PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. Its ability to image metastatic prostate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background ratios.Additionally, [18F] PyL demonstrated higher mean tumor-to-background ratios when using kidney, spleen, or parotid as reference organs. 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 Overview

• Status: Active, not recruiting
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: 18F- DCFPyL PET/CT

Detailed Description

The investigators will conduct a prospective phase II/III study of 300 men diagnosed with prostate cancer with a rising prostate-specific antigen (PSA). Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations and undergo 18F- DCFPyL PET/CT.

[18F]DCFPyL will be used for study imaging.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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:

1. Histologically confirmed diagnosis of prostate cancer
2. PSA ≥ 0.2ng/ml
3. Age ≥ 18 years of age
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (karnofsky ≥ 60%)
5. Ability to understand and willingness to sign a written informed consent document
6. Wiling to comply with clinical trial instructions and requirements
7. Willing to cover the cost of PyL PET/CT imaging if funds are not available

Exclusion Criteria:

1. History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
2. Presence of prostate brachytherapy implants unless approved by the PI
3. Administration of another radioisotope within five physical half-lives of trial enrollment
4. Radiation or chemotherapy within 2 weeks prior to trial enrollment
5. Serum creatinine > 3 times the upper limit of normal
6. Serum total bilirubin > 3 times the upper limit of normal
7. Aspartate transaminase (AST) or alanine aminotransferase (ALT) >5 times the upper limit of normal
8. Inadequate venous access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 18F- DCFPyL PET/CT; Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations including complete blood count (CBC), serum chemistries, hepatic panel, lactate dehydrogenase (LDH), and PSA. Liquid biopsies for circulating tumor DNA (ctDNA) and exosome analysis will occur at the same time. Subjects will then undergo 18F- DCFPyL PET/CT.

Drug: 18F- DCFPyL PET/CT; A CT scan using a radioactive marker to better image tumors; Other Names: CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis	To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis	3.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis, with regions being the prostate or prostate bed, pelvis, extra pelvis, and bones	To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis	3.5 years
To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis	To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis	3.5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize ctDNA and exosomes in patients with prostate cancer	To characterize ctDNA and exosomes in patients with prostate cancer	3.5 years
To determine correlation with ctDNA and/or exosome levels with disease burden	To determine correlation with ctDNA and/or exosome levels with disease burden	3.5 years

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Matthew C. Dallos, MD, Assistant Professor of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2019
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (ACTUAL): January 31, 2019

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: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: AAAS1862

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