NCT07577895Not yet recruiting
Pain Comparison: Transrectal vs. Transperineal Prostate Biopsy
Comparison of Anticipated and Experienced Pain Levels in Transrectal Versus Transperineal Prostate Biopsy
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 5 May 2026
- Start date
- 10 May 2026
- Primary completion date
- 10 Jul 2026
- Lead sponsor
- Kayseri Education and Research Hospital
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT07577895
What you commit to
- Study type: Observational
- Planned participants: 200
- From 10 May 2026 to the primary completion date, 10 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a history of previous prostate biopsy
- Patients with a previously confirmed diagnosis of prostate cancer
- 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 chronic pain syndromes or those receiving regular analgesic or opioid treatment that may affect pain perception
Other illness
- Patients with active urinary tract infection or prostatitis at the time of biopsy
- Patients with known allergy or hypersensitivity to local anesthetic agents
- Patients with cognitive impairment, psychiatric disorders, or language barriers preventing reliable use of the Visual Analog Scale (VAS)
Other
- Patients who refuse to participate or do not provide informed consent
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kayseri Education and Research Hospital Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.