Clinical trial NCT03585114: Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
Official title: Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Metastatic Prostate Cancer
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fifteen men will be recruited from Columbia University Medical Center.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of changes in PyL PET imaging correlating with radiographic Progression-Free Survival (rPFS)
timeFrame: Baseline, Post-treatment (approximately 6 weeks)
Secondary outcomes:
measure: Prevalence of changes in uptake of [18F]DCFPyL PET/CT scans correlating with Overall Survival (OS)
timeFrame: Baseline, Post-treatment (approximately 6 weeks)
measure: Prevalence of baseline SUVmax correlating with rPFS
timeFrame: Baseline, Post-treatment (approximately 6 weeks)
measure: Change in number of lesions detected with standard imaging at baseline and at the time of progression
timeFrame: Baseline, up to 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Matthew C. Dallos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.
citation: Szabo Z, Mena E, Rowe SP, Plyku D, Nidal R, Eisenberger MA, Antonarakis ES, Fan H, Dannals RF, Chen Y, Mease RC, Vranesic M, Bhatnagar A, Sgouros G, Cho SY, Pomper MG. Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Mol Imaging Biol. 2015 Aug;17(4):565-74. doi: 10.1007/s11307-015-0850-8.
citation: Rowe SP, Macura KJ, Mena E, Blackford AL, Nadal R, Antonarakis ES, Eisenberger M, Carducci M, Fan H, Dannals RF, Chen Y, Mease RC, Szabo Z, Pomper MG, Cho SY. PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. Mol Imaging Biol. 2016 Jun;18(3):411-9. doi: 10.1007/s11307-016-0957-6.