Prostate biopsy remains the gold standard for the diagnosis of prostate cancer and is most commonly performed using either the transrectal or transperineal approach. Although both techniques offer acceptable diagnostic accuracy, the pain experienced during and after the procedure is an important factor influencing the choice of biopsy approach and overall patient comfort. Pain perception in prostate biopsy is multifactorial, depending on the biopsy route, the number of needle insertions, the local anesthesia protocol, and the innervation of the relevant anatomical structures. The aim of this prospective study is to compare anticipated (pre-procedural expected) and experienced (post-procedural actual) pain levels in patients undergoing transrectal versus transperineal prostate biopsy, using the Visual Analog Scale (VAS). Findings are expected to contribute to clinical decision-making regarding biopsy approach selection with a focus on patient comfort.

Prostate biopsy is currently the gold standard diagnostic procedure for prostate cancer and is widely performed worldwide. In contemporary clinical practice, prostate biopsy is most frequently carried out using either the transrectal or the transperineal approach. While the diagnostic efficacy of both methods is considered acceptable, the pain perceived by patients during and after the procedure is a significant factor that influences the selection of the biopsy approach.

Pain perception during prostate biopsy is influenced by multiple variables, including the biopsy route, the number of needle insertions, the local anesthesia technique applied, and the innervation of the anatomical structures involved. In transrectal biopsy, the rectal wall is traversed, whereas in transperineal biopsy, the perineal skin and deeper tissues are penetrated; therefore, pain arises through different mechanisms in each technique. For this reason, comparing pain levels between the two biopsy approaches is of clinical importance for improving patient comfort.

The use of standardized assessment tools such as the Visual Analog Scale (VAS) allows the subjective pain experience of patients to be quantified and compared objectively. Previous studies utilizing VAS in prostate biopsy have reported differences in pain scores depending on the biopsy approach.

Although several studies have compared transrectal and transperineal biopsy approaches in terms of pain levels, the available evidence is heterogeneous due to differences in patient populations, anesthesia protocols, and timing of pain assessment. Furthermore, biopsy practices and patient expectations may vary across geographical regions, which can also influence pain perception. Therefore, prospective data obtained from our own patient population are expected to contribute to clinical decision-making processes regarding the selection of the biopsy approach with a particular focus on patient comfort.

Study Procedures Prior to the procedure, all patients scheduled to undergo prostate biopsy will receive detailed verbal and written information regarding both the transrectal and transperineal biopsy techniques, including their respective procedural steps, potential advantages, and possible disadvantages. Specifically, the advantages of transrectal biopsy (such as ease of application and shorter procedural time) and its potential disadvantages (such as the risk of infection) will be explained. Likewise, the advantages of transperineal biopsy (including a lower risk of infection and the ability to sample different anatomical regions), as well as its potential drawbacks (such as pain associated with perineal access and a longer procedural time), will be described.

Following this informational session, written informed consent will be obtained from all patients willing to participate in the study.

Anesthesia Protocol In order to standardize the anesthesia protocol and minimize its effect as a confounding variable on pain perception, periprostatic nerve block will be performed in both study arms. The same local anesthetic technique will be applied to all patients regardless of the biopsy approach (transrectal or transperineal), ensuring that any observed difference in pain scores between groups can be attributed to the biopsy route rather than to differences in anesthesia.

Outcome Assessment The sole focus of this study is the assessment of pain perception associated with the biopsy procedure; no other clinical endpoints (such as infection rates, bleeding complications, or diagnostic yield) will be evaluated within the scope of this study.

Anticipated pain levels will be assessed using the Visual Analog Scale (VAS) prior to the procedure, after the patient has been informed about both biopsy techniques. Experienced pain levels will be evaluated using the same scale as a single measurement immediately after the completion of the biopsy procedure. The primary objective of the study is to compare anticipated and experienced pain scores between patients undergoing transrectal and transperineal prostate biopsy.

Inclusion Criteria:

• Male patients aged 18 years and older Patients with clinical indication for prostate biopsy (elevated serum prostate-specific antigen [PSA] level, abnormal digital rectal examination [DRE], and/or suspicious lesion on multiparametric prostate magnetic resonance imaging [mpMRI])
• Patients undergoing prostate biopsy for the first time
• Patients able to understand and complete the Visual Analog Scale (VAS) for pain assessment
• Patients who have provided written informed consent to participate in the study

Exclusion Criteria:

• Patients with a history of previous prostate biopsy
• Patients with a previously confirmed diagnosis of prostate cancer
• Patients with active urinary tract infection or prostatitis at the time of biopsy
• Patients with anorectal pathology that may interfere with the transrectal approach (e.g., anal stenosis, active hemorrhoidal disease, anal fissure, prior rectal surgery)
• Patients with perineal pathology that may interfere with the transperineal approach (e.g., perineal infection, scarring, or prior surgery)
• Patients with bleeding diathesis or those receiving anticoagulant therapy that cannot be safely discontinued before the procedure
• Patients with known allergy or hypersensitivity to local anesthetic agents
• Patients with chronic pain syndromes or those receiving regular analgesic or opioid treatment that may affect pain perception
• Patients with cognitive impairment, psychiatric disorders, or language barriers preventing reliable use of the Visual Analog Scale (VAS)
• Patients who refuse to participate or do not provide informed consent

This study includes only male participants because prostate biopsy is performed exclusively in patients with a prostate gland, which is an anatomical structure present only in biological males."

The study population consists of male patients with a clinical indication for prostate biopsy, including elevated serum prostate-specific antigen (PSA) levels, abnormal findings on digital rectal examination (DRE), and/or suspicious lesions detected on multiparametric prostate magnetic resonance imaging (mpMRI). Patients will be recruited consecutively from the urology outpatient clinic and will undergo prostate biopsy via either the transrectal or transperineal approach. Only patients undergoing prostate biopsy for the first time, who are able to understand and complete the Visual Analog Scale (VAS) for pain assessment, and who provide written informed consent will be included.