Skip to main content
OpenTrials
Completed

NCT Number: NCT03783741

The Biopsychosocial Burden of Prostate Biopsy

Prostate biopsy was offered to 47 consecutive patients with prostate-specific antigen (PSA) over 4 ng/dl or suspicious digital rectal examination (DRE) of whom 16 had undergone a biopsy. Comprehensive validated questionnaires at TIME 0 (pre-biopsy), TIME 1 (before diagnosis, 20 days after biopsy) and TIME 2 (after diagnosis, 40 days after biopsy) accessed patients' erectile (IIEF-5) and voiding (IPSS) functions, Beck scales measured anxiety (BAI), hopelessness (BHS) and depression (BDI), added to the emotional thermometers including five visual analog scales for distress, anxiety, depression, anger and need for help. Mann-Whitney or Friedman tests were obtained among times and studied variables.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hospital das Clínicas Unicamp

Campinas, São Paulo, 13083-887, Brazil

About this study

A prospective, longitudinal and observational study in which the sexually active patients were evaluated in the Urology Department of the city of Paulínia, submitted to biopsy guided by transrectal ultrasound after ethics committee approval (355.357).

Consecutive patients who were attended by urologist and present prostate cancer suspicions (PSA> 4 ng / dL and/or rectal examination (TR) were submitted a BXP. They were evaluated at three different moments of the biopsy:

  • Seven days before the biopsy procedure (T0);
  • 20 days after the biopsy, upon receiving the histopathological result, before becoming aware of it (T1);
  • 40 days after the biopsy, 20 days after being aware of the test result (T2). Sixty-one consecutive patients were invited to participate in the study, 10 of them had no active sexual life and 9 answered the questionnaires only at the first moment, were excluded; 47 responded at three times (T0, T1, and T2).

Validated instruments were applied - IIEF-5 (erectile function); - IPSS (voiding function); - Beck scales - BAI (anxiety), BHS (hopelessness), BDI (depression); and - Emotional thermometers.

The comparison among the moments (T0, T1, and T2) was performed through Friedman (analysis of variance) for repeated measures with the variables transformed in stations. The comparison between patients and variables was performed using the Mann-Whitney test. The sample power was calculated and the level of significance considered was 5%.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • prostate cancer suspicion (PSA > 4 ng / dL, digital rectal examination)

Exclusion criteria

  • not agree to participate

Treatment and study plan

Questionnaire

Behavioral

Interview

Primary outcomes

  1. Erectile Function

    Time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)

    International Index of Erectile Function - IIEF-5 index (range 0-25; higher better)

  2. Voiding Function

    Time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)

    International Prostatic Symptoms Score - IPSS (range 0-35; higher worse)

  3. Beck scale

    Time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)

    Beck Anxiety Index - BAI (0-63; higher worse)

  4. Emotional thermometers

    Time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)

    Thermometer score (range 0-10; higher worse)

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

The Biopsychosocial Burden of Prostate Biopsy at the Time of Its Indication, Procedure, and Pathological Report

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 21, 2018
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.