Clinical trial NCT03824275: 18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer
Official title: 18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Prostatic Neoplasms
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 129
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis
timeFrame: 3.5 years
Secondary outcomes:
measure: 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
timeFrame: 3.5 years
measure: To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis
timeFrame: 3.5 years
Other outcomes:
measure: To characterize ctDNA and exosomes in patients with prostate cancer
timeFrame: 3.5 years
measure: To determine correlation with ctDNA and/or exosome levels with disease burden
timeFrame: 3.5 years
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Assistant Professor of Medicine
name: Matthew C. Dallos, MD
role: PRINCIPAL_INVESTIGATOR
References: