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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03824275
• Other study ID #: AAAS1862
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: February 12, 2019
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To characterize ctDNA and exosomes in patients with prostate cancer	To characterize ctDNA and exosomes in patients with prostate cancer	3.5 years
Other	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
Primary	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	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
Secondary	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