NCT03824275Active, not recruitingPhase 2/3
18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer
Source: ClinicalTrials.gov · Last updated 11 May 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 129 (actual)
- First submitted
- 29 Jan 2019
- Start date
- 12 Feb 2019
- Primary completion date
- Dec 2022
- Lead sponsor
- Columbia University
- Diseases
- Prostate cancer
- NCT number
- NCT03824275
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 129
- From 12 Feb 2019 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 design.
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 unless approved by the PI
- 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 transaminase (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
- PSA ≥ 0.2ng/ml
- Age ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (karnofsky ≥ 60%)
- Ability to understand and willingness to sign a written informed consent document
- Wiling to comply with clinical trial instructions and requirements
- Willing to cover the cost of PyL PET/CT imaging if funds are not available
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile 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.