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Table 4-14PSA - Summary of findings

StudyStudy designPopulationIntervention & comparisonAnalysisOutcome
Crawford 2006, 57 analysing data from McConnell 2003189,191Longitudinal follow up of the placebo arm of an RCT with 4 years follow upMen with BPH and moderate to severe symptom (AUASS) mean 17 (range of 8-20). The average age was 62 years.

(N=737)
None
(placebo arm)
Patients in the placebo arm of the trial were divided into high

(≥1.6ng/ml) vs. low
(<1.6ng/ml) PSA at the median baseline level.

Overall BPH progression was defined as the first occurrence of an increase of at least 4 points in the AUASS, AUR, urinary incontinence or renal insufficiency or recurrent urinary tract infection.
Baseline PSA level was associated with symptom progression.

At 4 years, the cumulative probability and incidence rate of overall BPH progression was significantly higher in the baseline high PSA group (p<0.001).

Incidence rate of ≥ 4 points increase in AUASS was significantly higher in the high PSA group (4.5 vs. 2.8 events/100 person year). The incidence rate of acute urinary retention and invasive therapy was also significantly higher in the group with higher baseline PSA.
Carter 200546Longitudinal cohort study.Healthy men less than 70 years
(N=704).
NoneRegression analysis (mixed effect Poisson model) for change in PSA percentile group and symptom score (IPSS score) with time.No correlation (analysis not shown).
O'Leary 2003229Analysis from 3 RCTs with a 2 year follow up.Men with BPH
(N=4335), moderate to severe symptoms.
Dutasteride vs. placeboLogistic regression model to identify predictors for men most likely to be bothered at the end of the study.PSA at baseline was not one of the factors which predicted bother (as measured by item 3 of BII - Benign Prostatic Hyperplasia Impact Index).
Roehrborn 1999256RCT with follow up of 4 years.Men with clinical BPH, moderate to severe symptoms
(N=3040)
Finasteride vs. placeboMean change in quasi-AUA symptom score over time. Analysis of variance within PSA tertiles and between treatment group.Baseline PSA predicts deterioration of symptoms in untreated patients. Baseline PSA predicts improvement of symptoms for those patients treated with finasteride relative to placebo
Baseline PSA does not predict improvement of symptoms in the finasteride treatment group alone.
Roehrborn 2006255RCTMen at risk of progression events from LUTS/BPH
(N=1522)
Alfuzosin vs. placeboAnalysis of baseline PSA as predictor of IPSS using logistic regression expressed as hazard ratios.PSA levels were not found to be a significant predictor of IPSS worsening in the intervention or placebo arm

From: 4, Diagnosis

Cover of The Management of Lower Urinary Tract Symptoms in Men
The Management of Lower Urinary Tract Symptoms in Men [Internet].
NICE Clinical Guidelines, No. 97.
National Clinical Guideline Centre (UK).
Copyright © 2010, National Clinical Guideline Centre.

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