Protocol for a prospective study evaluating circulating tumour cells status to predict radical prostatectomy treatment failure in localised prostate cancer patients (C-ProMeta-1)
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Volume
23
Publisher
Publisher URL
DOI
10.1186/s12885-023-11081-0
Journal
BMC Cancer
Issue
ISSN
1471-2407
Metadata
Show full item recordAbstract
Background Treatment decisions in prostate cancer (PCa) rely on disease stratifcation 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 epitopeindependent 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 samples (20 ml) 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 defned 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. Specifcity will be presented over time.
Discussion CTC status may refect 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 treat‑
ment failure in localized high-risk PCa would signifcantly enhance guidance in treatment decision-making, optimiz‑
ing cure rates while minimizing unnecessary harm from overtreatment.
Trial registration ISRCTN17332543.