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

• ClinicalTrials.gov Identifier: NCT03824275
• Recruitment Status: Active, not recruiting
• First Posted: January 31, 2019
• Last Update Posted: May 11, 2022
• Sponsor: Columbia University
• Information provided by (Responsible Party): Matthew Dallos, Columbia University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostatic Neoplasms	Drug: 18F- DCFPyL PET/CT	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 129 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, non-randomized
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer
• Actual Study Start Date: February 12, 2019
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2023

Arms and Interventions

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 Name: CT scan

Outcome Measures

Primary Outcome Measures :

1. To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis [ Time Frame: 3.5 years ]
   To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis

Secondary Outcome Measures :

1. 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 [ Time Frame: 3.5 years ]
   To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis
2. To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis [ Time Frame: 3.5 years ]
   To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis

Other Outcome Measures:

1. To characterize ctDNA and exosomes in patients with prostate cancer [ Time Frame: 3.5 years ]
   To characterize ctDNA and exosomes in patients with prostate cancer
2. To determine correlation with ctDNA and/or exosome levels with disease burden [ Time Frame: 3.5 years ]
   To determine correlation with ctDNA and/or exosome levels with disease burden

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

Columbia University Irving Medical Center

New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

• Principal Investigator: Matthew C. Dallos, MD; Assistant Professor of Medicine

More Information

• Responsible Party: Matthew Dallos, Associate Clinical Professor of Medicine, Columbia University
• ClinicalTrials.gov Identifier: NCT03824275
• Other Study ID Numbers: AAAS1862
• First Posted: January 31, 2019
• Last Update Posted: May 11, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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