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

NCT03824275 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AAAS1862
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  3.5 years

• To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis

  3.5 years

Other Outcomes (2)

• 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

  3.5 years

Study Arms (1)

18F- DCFPyL PET/CT

EXPERIMENTAL

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

Interventions

18F- DCFPyL PET/CT DRUG

A CT scan using a radioactive marker to better image tumors

Also known as: CT scan

18F- DCFPyL PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
• Presence of prostate brachytherapy implants unless approved by the PI
• 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 transaminase (AST) or alanine aminotransferase (ALT) \>5 times the upper limit of normal
• Inadequate venous access

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Matthew C. Dallos, MD

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Medicine

Model Details: Prospective, non-randomized

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: February 12, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)