Protocol for a Prospective Study Evaluating Circulating Tumour Cells Status to Predict Radical ProstatectomyTreatment Failure in Localised Prostate Cancer Patients (C- ProMeta-1)
Author:
Al-Hammouri Tarek1, Almeida-Magana Ricardo1, Lawrence Rachel2, Duffy Tom3, White Laura3, Burke Edwina2, Kudahetti Sakunthala2, Collins Justin1, Rajan Prabhakar1, Berney Daniel2, Gabe Rhian3, Shaw Greg1, Lu Yong-Jie2
Affiliation:
1. University College London Hospitals 2. Queen Mary University of London, Barts Cancer Institute 3. Queen Mary University of London, Wolfson Institute of Preventive Medicine
Abstract
Abstract
Background: Treatment decisions in prostate cancer (PCa) rely on disease stratification between localised and metastatic stages, but current imaging staging technologies are not sensitive to micro-metastatic disease. Circulating tumour cells (CTCs) status is a promising tool in this regard. The Parsortix® CTC isolation system employs an epitope-independent approach based on cell size and deformability to increase the capture rate of CTCs. Here, we present a protocol for prospective evaluation of this method to predict post radical prostatectomy (RP) PCa cancer recurrence.
Methods: We plan to recruit 294 patients diagnosed with unfavourable intermediate, to high and very high-risk localised PCa. Exclusion criteria include synchronous cancer diagnosis or prior PCa treatment, including hormone therapy. RP is performed according to the standard of care. Two blood sample (20ml) are collected before and again 3-months after RP. The clinical team are blinded to CTC results and the laboratory researchers are blinded to clinical information. Treatment failure is defined as a PSA ≥ 0.2 mg/ml, start of salvage treatment or imaging-proven metastatic lesions. The CTC analysis entails enumeration and RNA analysis of gene expression in captured CTCs. The primary outcome is the accuracy of CTC status to predict post-RP treatment failure at 4.5 years. Observed sensitivity, positive and negative predictive values will be reported. Specificity will be presented over time.
Discussion: CTC status may reflect the true potential for PCa metastasis and may predict clinical outcomes better than the current PCa progression risk grading systems. Therefore establishing a robust biomarker for predicting treatment failure in localized high-risk PCa would significantly enhance guidance in treatment decision-making, optimizing cure rates while minimizing unnecessary harm from overtreatment.
Trial registration: ISRCTN17332543
Publisher
Research Square Platform LLC
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