Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study

Abstract

Objectives To measure the effect of the adverse events within 35 days of transrectal ultrasound guided biopsy from the perspective of asymptomatic men having prostate specific antigen (PSA) testing; to assess early attitude to re-biopsy; to estimate healthcare resource use associated with adverse events due to biopsy; and to develop a classification scheme for reporting adverse events after prostate biopsy.Design Prospective cohort study (Prostate Biopsy Effects: ProBE) nested within Prostate Testing for Cancer and Treatment (ProtecT) study.Participants Between 1999 and 2008, 227 000 community dwelling men aged 5069 years were identified at 352 practices and invited to counselling about PSA testing. 111 148 attended a nurse led clinic in the community, and 10 297 with PSA concentrations of 3-20 ng/mL were offered biopsy within ProtecT. Between February 2006 and May 2008, 1147/1753 eligible men (mean age 62.1 years, mean PSA 5.4 ng/mL) having 10 core transrectal ultrasound guided biopsy under antibiotic cover in the context of ProtecT were recruited to the ProBE study.Outcome measures Purpose designed questionnaire administered at biopsy and 7 and 35 days after the procedure to measure frequency and effect of symptoms related to pain, infection, and bleeding; patients' attitude to repeat biopsy assessed immediately after biopsy and 7 days later; participants' healthcare resource use within 35 days of biopsy evaluated by questionnaire, telephone follow-up, and medical note review; each man's adverse event profile graded according to symptoms and healthcare use.Results Pain was reported by 429/984 (43.6%), fever by 172/985 (17.5%), haematuria by 642/976 (65.8%), haematochezia by 356/967 (36.8%), and haemoejaculate by 605/653 (92.6%) men during the 35 days after biopsy. Fewer men rated these symptoms as a major/moderate problem-71/977 (7.3%) for pain, 54/981 (5.5%) for fever, 59/958 (6.2%) for haematuria, 24/951 (2.5%) for haematochezia, and 172/646 (26.6%) for haemoejaculate. Immediately after biopsy, 124/1142 (10.9%, 95% confidence interval 9.2 to 12.8) men reported that they would consider further biopsy a major or moderate problem: seven days after biopsy, this proportion had increased to 213/1085 (19.6%, 17.4% to 22.1%). A negative attitude to repeat biopsy was associated with unfavourable experience after the first biopsy, particularly pain at biopsy (odds ratio 8.2, P<0.001) and symptoms related to infection (7.9, P<0.001) and bleeding (4.2, P<0.001); differences were evident between centres (P<0.001). 119/1147 (10.4%, 8.7% to 12.3%) men reported consultation with a healthcare professional (usually their general practitioner), most commonly for infective symptoms. Complete data for all index symptoms at all time points were available in 851 participants. Symptoms and healthcare use could be used to grade these men as follows: grade 0 (no symptoms/contact) 18 (2.1%, 1.3% to 3.3%); grade 1 (minor problem/no contact) 550 (64.6%, 61.4% to 67.8%); grade 2 Conclusion This study with a high response rate of...

Complications After Systematic, Random, and Image-guided Prostate Biopsy

“…Patient-related factors, such as prostate volume and medical comorbidities also influence the risk of hematuria. In a large prospective cohort of 1147 men undergoing TRUS-guided PB, hematuria was reported by 65.8% of patients within 35 days, but only 6.2% of them considered it bothersome 7 . In the European Randomized Study for Prostate Cancer (ERSPC), hematuria lasting more than 3 days occurred in 22.6% of cases, and was significantly correlated with higher prostate and transition zone volumes (p<0.001) 11 .…”

“…The presence of visible blood in the ejaculate is the most variably reported complication after prostate biopsy, ranging from 1.1%-92.6% 1,5,7,11,13,17 . Unlike hematuria or rectal bleeding, hematospermia could have a transient detrimental effect on sexual activity or trigger anxiety 7,17 .…”

“…As with hematuria, in the vast majority of men rectal bleeding is self-limiting and rarely bothersome. Indeed, in a large prospective study, rectal bleeding was common (36.8%), but only 2.5% of all patients found it a major or moderate problem according to the National Cancer Institute's criteria 7 . Lower rates were reported within the ERSPC study (1.3%), with no correlation between hematochezia and other clinical parameters 11 .…”

“…Unlike hematuria or rectal bleeding, hematospermia could have a transient detrimental effect on sexual activity or trigger anxiety 7,17 . In a large prospective cohort from the UK screening study, Rosario et al reported hematospermia in 92.6% of patients within 35 days after PB, and 26.6% perceived it as a moderate/serious and bothersome problem 7 .…”

Pain related and overall morbidity with TRUS guided prostate biopsy a prospective study

“…The ProBE trial has shown that although 85% of the patients undergoing TRUSBx described no or mild procedure associated pain during TRUSBx but within 35 days pain was an undesirable effect in 44% of which 7% found it to be a moderate or serious problem (11).…”