© 2 0 0 5 B J U I N T E R N A T I O N A L | 9 5 , 9 6 9 – 9 7 1 | doi:10.1111/j.1464-410X.2005.05449.x 969 Original Article DRE IN THE DIAGNOSIS AND CLINICAL STAGING OF EARLY PROSTATE CANCER PHILIP et al. Is a digital rectal examination necessary in the diagnosis and clinical staging of early prostate cancer? JOE PHILIP, SUBHAJIT DUTTA ROY*, MOHAMMED BALLAL*, CHRISTOPHER S. FOSTER† and PRADIP JAVLÉ Departments of Urology and *Surgery, Leighton Hospital, Crewe, and †Department of Pathology, Royal Liverpool University Hospital, Liverpool, UK Accepted for publication 29 November 2004 study. They had a DRE by either of two experienced consultant urologists. The results of the DRE and core biopsy histology were compared with the histology and the radical prostatectomy specimen in a subset (82 men) of the study population. RESULTS Cancer was detected on biopsy in 152 patients; of the 196 with an abnormal DRE, 47% had cancer on biopsy. In the patients with a normal DRE, 59 cancers were detected. Men with cancer were older and had a higher median PSA level. There was no correlation between the DRE and biopsy findings, and none between an abnormal DRE and histological diagnosis of cancer. Of the patients who had a radical prostatectomy, 38% had a normal DRE. CONCLUSION There was no correlation between the DRE, biopsy findings and pathological staging. The DRE did not contribute to managing patients with prostate cancer, but this does not mean that there is no longer a place for the DRE in assessing the urological patient. If patients are appropriately counselled before PSA testing, a DRE may not be essential for patients with a PSA level of 2.5–10 ng/mL. KEYWORDS prostate cancer, digital rectal examination, cancer detection rate OBJECTIVE To assess the role of a digital rectal examination (DRE) in the clinical diagnosis of prostate cancer and in predicting the pathological stage, as the diagnosis of early prostate cancer usually comprises prostate- specific antigen (PSA) testing, a DRE and transrectal ultrasonography (TRUS)-guided biopsies. PATIENTS AND METHODS Over the 4 years between 2000 and 2004, 408 consecutive patients (mean age 63.8 years) referred with age-specific PSA levels of 2.5–10.0 ng/mL and who had a TRUS-guided 12-core prostate biopsy were included in the INTRODUCTION Prostate cancer is the commonest cancer in men, accounting for >27 000 new cancer cases in the UK in 2000 and nearly 9900 deaths in 2002 [1]. A substantial increase in the incidence of prostate cancer has been reported in the UK [2], caused by an increased awareness of prostate cancer and widespread PSA testing. This becomes increasingly important in an ageing population, with almost 9 million men aged >50 years, accounting for >31% of the total male population in 2002 [3]. The diagnosis of early prostate cancer comprises a PSA assay, a DRE and TRUS- guided biopsy of the prostate. PSA remains the most important tool for investigating and managing patients with suspected and confirmed carcinoma of the prostate [4]. Patients with a high age-specific PSA level and/or an abnormal DRE are commonly offered a TRUS-guided systematic prostate biopsy. The DRE is considered to be mandatory in the diagnosis and staging of prostate cancer but studies investigating the accuracy of a DRE for these purposes have yielded conflicting reports [5–8]. The DRE can be uncomfortable and embarrassing, irrespective of the examiner’s level of experience, with a low compliance for repeat visits [9,10]. The present study aimed to assess the value of a DRE in the diagnosis and staging of early prostate cancer in men referred with elevated PSA values. PATIENTS AND METHODS Over 4 years from January 2000 to December 2003, 408 consecutive patients (mean age 63.8 years, range 43–84, SD 7.5) referred with age-specific PSA levels of 2.5–10.0 ng/mL and who had TRUS-guided 12-core prostate biopsies were included in the study; these patients had urinary symptoms or were asymptomatic but with a raised PSA level. The patients had a DRE in the outpatient clinic by either of two experienced consultant urologists; the patients then went on to have a 12-core TRUS-guided systematic prostate biopsy that included six peripheral cores, as previously defined in our earlier study [11]. Individual cores were analysed histologically according to current histological practice [12]. The DRE findings were comparatively analysed against age, PSA and histological diagnosis of prostate cancer, and assessed in relation to the presence of prostate cancer and the biopsy stage. In the patients who chose to have a radical prostatectomy (82), the correlation of DRE with final pathological staging was also assessed. The results were analysed statistically using standard statistical software, with Student’s t-test used to compare numeric variables. Measures of disagreement were analysed by McNemar’s test, while the Armitage proportion trend test was used to study test trends; for all comparisons P < 0.05 was considered to indicate statistical significance.