NCT03585114Active, not recruitingPhase 2
Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
Source: ClinicalTrials.gov · Last updated 11 May 2022
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 29 Jun 2018
- Start date
- 11 Dec 2018
- Primary completion date
- Dec 2022
- Lead sponsor
- Columbia University
- Diseases
- Prostate cancer
- NCT number
- NCT03585114
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 11
- From 11 Dec 2018 to the primary completion date, Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of prostate brachytherapy implants
- Radiation or chemotherapy within 2 weeks prior to trial enrollment
Other illness
- History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
Lab values
- 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
Other
- Administration of another radioisotope within five physical half-lives of trial enrollment
- Inadequate venous access
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.