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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Published:2023-06-23
Issue:1
Volume:23
Page:
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ISSN:1471-2407
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Container-title:BMC Cancer
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language:en
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Short-container-title:BMC Cancer
Author:
Al-Hammouri Tarek,Almeida-Magana Ricardo,Lawrence Rachel,Duffy Tom,White Laura,Burke Edwina,Kudahetti Sakunthala,Collins Justin,Rajan Prabhakar,Berney Daniel,Gabe Rhian,Shaw Greg,Lu Yong-Jie
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 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 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.
Funder
Prostate Cancer UK
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Genetics,Oncology
Reference22 articles.
1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209–49. 2. Rider JR, Sandin F, Andrén O, Wiklund P, Hugosson J, Stattin P. Long-term Outcomes Among Noncuratively Treated Men According to Prostate Cancer Risk Category in a Nationwide. Population-based Study Eur Urol. 2013;63(1):88–96. 3. N. Mottet PC, R.C.N. van den Bergh, E. Briers, M. De Santis, S. Gillessen, J. Grummet, A.M. Henry, T.H. van der Kwast, T.B. Lam, M.D. Mason, S. O’Hanlon, D.E. Oprea-Lager, G. Ploussard, H.G. van der Poel, O. Rouvière, I.G. Schoots. D, Tilki, T. Wiegel, T. Van den Broeck, M. Cumberbatch, A. Farolfi, N. Fossati, G. Gandaglia, N. Grivas, M. Lardas, M. Liew, E. Linares Espinós, L. Moris, P-P.M. Willemse. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer: European Association of Urology; 2022. Available from: https://uroweb.org/guidelines/prostate-cancer. [cited 2023 May 17]. 4. Risko R, Merdan S, Womble PR, Barnett C, Ye Z, Linsell SM, et al. Clinical predictors and recommendations for staging CT scan among men with prostate cancer. Urology. 2014;84(6):1329–34. 5. 68Ga-PSMA PET/CT for Primary Lymph Node and Distant Metastasis NM Staging of High-Risk Prostate Cancer | Journal of Nuclear Medicine. Available from: https://jnm.snmjournals.org/content/62/2/214.long. [cited 2023 May 15].
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