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

Phase 2

Active, not recruiting

• Conditions: Prostatic Neoplasms
• Interventions: Drug: 18F- DCFPyL PET/CT

• Registration Number: NCT03824275
• Lead Sponsor: Columbia University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Study Start: 2019-02-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-11
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 129

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F- DCFPyL PET/CT	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.

Primary Outcome Measures

Name	Time	Method
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis	3.5 years	To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis

Secondary Outcome Measures

Name	Time	Method
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 positive predictive value of 18F-DCFPyL PET/CT on a per-region basis
To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis	3.5 years	To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States