Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/31/2019 |
| Start Date: | December 11, 2018 |
| End Date: | December 2020 |
| Contact: | Ana Serra |
| Email: | as5713@cumc.columbia.edu |
| Phone: | (212) 342-0248 |
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
- 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
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.
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.
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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Emerson Lim, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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