The Biopsychosocial Burden of Prostate Biopsy

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT03783741
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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.

Detailed Description

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%.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-01
• Study Completion: 2016-10
• Status Verified: 2018-12
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-20
• Study First Posted: 2018-12-21
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 47

Inclusion Criteria

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

Exclusion Criteria

• not agree to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Erectile Function	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)
Voiding Function	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)
Beck scale	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)
Emotional thermometers	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)

Trial Locations

Locations (1)

Hospital das Clínicas Unicamp; 🇧🇷 Campinas, SP, Brazil