Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers

Phase 2

Active, not recruiting

Brief Summary: Primary Objective:

* To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria.

Secondary Objectives:

* To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans correlate with overall survival (OS)

* To determine whether baseline SUVmax correlate with rPFS

* To compare number of lesions detected with standard imaging at baseline and at the time of progression

Detailed Description: Prostate cancer is the most common cancer and the third most common cause of cancer deaths in American men. The lethal form of the disease is metastatic castrate resistant prostate cancer (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy.

PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. 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.

Recruitment & Eligibility

Inclusion Criteria

Histologically confirmed diagnosis of prostate cancer
Age ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working Group 3
Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease
Ability to understand and willingness to sign a written informed consent document
Wiling to comply with clinical trial instructions and requirements

Exclusion Criteria

History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
Presence of prostate brachytherapy implants
Administration of another radioisotope within five physical half-lives of trial enrollment
Radiation or chemotherapy within 2 weeks prior to trial enrollment
Serum creatinine > 3 times the upper limit of normal
Serum total bilirubin > 3 times the upper limit of normal
Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >5 times the upper limit of normal
Inadequate venous access

Arm && Interventions

Group	Intervention	Description
PyL-PET	[F-18] DCFPyL	Male participants diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment will receive \[F-18\] DCFPyL PET/CT imaging before starting new treatment and after 6 weeks on treatment.
PyL-PET	PET/CT imaging	Male participants diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment will receive \[F-18\] DCFPyL PET/CT imaging before starting new treatment and after 6 weeks on treatment.

Primary Outcome Measures

Name	Time	Method
Prevalence of changes in PyL PET imaging correlating with radiographic Progression-Free Survival (rPFS)	Baseline, Post-treatment (approximately 6 weeks)	To determine if changes in PyL PET/CT scans before and after 6 weeks on treatment is associated with stability of disease as measured by standard imaging.

Secondary Outcome Measures

Name	Time	Method
Prevalence of changes in uptake of [18F]DCFPyL PET/CT scans correlating with Overall Survival (OS)	Baseline, Post-treatment (approximately 6 weeks)	The percent difference in summed SUV between the first and second PET/CT will be noted.
Prevalence of baseline SUVmax correlating with rPFS	Baseline, Post-treatment (approximately 6 weeks)	To determine if standardized uptake values (SUVs) at baseline is a good measure for patient evaluation.
Change in number of lesions detected with standard imaging at baseline and at the time of progression	Baseline, up to 1 year	To compare lesions detected with standard imaging

Locations (1): Columbia University Irving Medical Center
🇺🇸
New York, New York, United States