A Phase 3 interventional study of DCFPyL in Prostate Cancer Recurrent, sponsored by Curium PET France. Status unknown at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Curium PET France · Phase 3, Interventional, and Diagnostic
PYTHON is designed to establish the efficacy and safety of 18F-DCFPyL in comparison with that of 18F-fluorocholine, in patients with first biochemical recurrence (BCR) after initial definitive therapy (prostatectomy, external beam radiotherapy or brachytherapy) for histopathologically confirmed prostate adenocarcinoma per original diagnosis. PET/CT scans will be each interpreted by three independent masked experts who are not otherwise involved in the trial.
The primary objective is the per-patient detection rate of 18F-DCFPyL in comparison with 18F-Fluorocholine. Secondary objectives include the assessment of the impact on patient treatment management, the per-region detection rate, the sensitivity and specificity on a per-patient and per-region basis, the concordance rate between both tracers, and the safety. The study was initiated in July 2020, and the recruitment of the planned 217 patients has been completed in October 2020. The follow-up phase is ongoing. Typically, as part of the routine care practice, these patients receive appropriate treatment and follow-up. The investigating sites are therefore requested for the period of 7 months after the second tracer injection, to provide any results of subsequent biopsies, imaging studies, clinical findings, PSA measurements, and disease management, if performed in routine practice. Treatment decisions are locally made at the discretion of the referring physician based on all available clinical information, including the non-masked local reports of both PET/CT and any other imaging results. After completion of the study, a consensus will be obtained from a multidisciplinary independent board (truth panel), based on the surrogate standard of reference which will include all the above-mentioned available results. Assessments will be made on a per-region and per-patient basis. The truth panel will consist in 3 independent experts not otherwise involved in the trial. All above information will be sequentially presented to the truth panel experts. The order of presentation of 18F-FCH PET/CT and 18F-DCFPyl PET/CT results will be randomized. The truth panel will have to assess the impact of each PET/CT examination on disease restaging and change in treatment intent, by filling in a patient management questionnaire after review of each PET/CT examination report.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 217 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Curium PET France as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients displaying any of the following criteria will not be included:
Single dose injection
to compare per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT.
Time frame: 10 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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