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.
Who can participate
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of Experienced Pain Scores Between Transrectal and Transperineal Prostate Biopsy Groups
Timeframe: Within 15 minutes after completion of the biopsy procedure