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National Collaborating Centre for Cancer (UK). Prostate Cancer: Diagnosis and Treatment. Cardiff (UK): National Collaborating Centre for Cancer (UK); 2014 Jan. (NICE Clinical Guidelines, No. 175.)

  • In May 2019, NICE updated and replaced this guideline with NICE guideline NG131 on prostate cancer: diagnosis and management. Some of the 2014 recommendations have been retained in the new guideline. This document preserves evidence reviews and committee discussions for areas of the guideline that have not been updated in 2019. The PDF has been colour coded as follows: all text without shading is from the original 2014 guideline and has not been amended by subsequent updates. Black shading indicates text from 2014 has been replaced by the 2019 update.

In May 2019, NICE updated and replaced this guideline with NICE guideline NG131 on prostate cancer: diagnosis and management. Some of the 2014 recommendations have been retained in the new guideline. This document preserves evidence reviews and committee discussions for areas of the guideline that have not been updated in 2019. The PDF has been colour coded as follows: all text without shading is from the original 2014 guideline and has not been amended by subsequent updates. Black shading indicates text from 2014 has been replaced by the 2019 update.

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Prostate Cancer: Diagnosis and Treatment.

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Appendix AProstate Specific Antigen (PSA)

PSA is a protein, expressed by both normal and malignant prostate cells. Serum PSA levels may rise for reasons such as infection or glandular enlargement due to benign prostatic hyperplasia (BPH) and is therefore not a specific marker for prostate cancer. In addition the levels can fluctuate naturally over time.

The traditional range for normal PSA refers to total PSA levels (tPSA) and anything up to 4 ng/ml was considered satisfactory. Above this value a biopsy would be considered. However, only around 30% of men will have prostate cancer on biopsy with levels between 4–10 ng/ml (Raaijmakers et al. 2004). Conversely as many as 15% of men with PSA values below 4 ng/ml will have cancer, of which some will be clinically significant. As such, a cut-off of 4 ng/ml is not ideal and in clinical practice there is no precise single PSA value in isolation at which to recommend a biopsy.

The concept of age adjusted PSA values evolved to allow for the influence of age on PSA, thus reducing the chance of missing a tumour in a younger man whilst avoiding unnecessary investigation in older men. Thus for a man of 70 years a higher upper PSA limit of 6.5 ng/ml would be acceptable whilst for a man of 45 years a PSA value of 2.5 ng/ml may be considered the upper limit of normal. By lowering the PSA cut off in younger men there is a potential risk that the over detection of clinically insignificant cancers may increase.

Refinements of the traditional PSA test, measuring tPSA have been employed to increase specificity, including the measurement of free-to-total PSA ratio (ftPSA) or of complexed PSA (cPSA). These are of most value in the PSA range 2–10 ng/ml and might reduce the number of unnecessary biopsies. In addition, f/tPSA ratio may offer prognostic information - those men with lower ratio potentially harbouring a more aggressive disease.

The concept of ‘PSA kinetics’ is not new but worthy of note. PSA velocity (PSAv) refers to the absolute rate of PSA change over time. Recent evidence has indicated that PSAv may need to take into account both age and individual PSA value to optimise interpretation. In clinical practice, a minimum of three values is required over at least 18 months for a meaningful assessment. It may offer prognostic information as to how an individual prostate cancer may behave after diagnosis with a rise in over 2 ng/ml in the year prior to diagnosis predicting a more aggressive disease course or higher post-therapy relapse rate (D’Amico et al. 2005). PSA doubling time (PSAdt) refers to the time taken for a serum PSA value to double and is also emerging as useful pre-treatment marker of a prostate tumour’s biological potential (Klotz 2005). A calculated PSAdt of less than 3 years may indicate a more aggressive tumour course.

A.1. References

  • D’Amico AV, Renshaaw AA, Sussman B, Chen MH. Pre-treatment PSA velocity and the risk of death from prostate cancer following external beam radiotherapy. N Eng J Med. 2005;294:440–7. [PubMed: 16046650]
  • Klotz L. Active surveillance with selective delayed intervention using PSA doubling time for good risk prostate cancer. Eur Urol. 2005;47:16–21. [PubMed: 15582244]
  • Raaijmakers R, Wildhagen MF, Ito K, et al. Prostate-specific antigen change in the European Randomized Study of Screening for Prostate Cancer, section Rotterdam. Urology. 2004;63:316–20. [PubMed: 14972481]
Copyright © National Collaborating Centre for Cancer.
Bookshelf ID: NBK248397

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