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

NCT ID: NCT03824275

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2023-12-31

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.

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.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

18F- DCFPyL PET/CT

Intervention Type: DRUG

A CT scan using a radioactive marker to better image tumors

Interventions

18F- DCFPyL PET/CT

A CT scan using a radioactive marker to better image tumors

Intervention Type: DRUG

Other Intervention Names

CT scan

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Matthew Dallos

Associate Clinical Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew C. Dallos, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAS1862

Identifier Type: -

Identifier Source: org_study_id