The Biopsychosocial Burden of Prostate Biopsy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03783741
• Other study ID #: Prostate Biopsy Burden
• Status: Completed
• Start date: January 2014
• Est. completion date: October 2016

Study information

• Verified date: December 2018
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 2016
• Est. primary completion date: January 2015
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• not agree to participate

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Questionnaire
Interview

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas Unicamp	Campinas	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Naccarato AM, Reis LO, Matheus WE, Ferreira U, Denardi F. Barriers to prostate cancer screening: psychological aspects and descriptive variables---is there a correlation? Aging Male. 2011 Mar;14(1):66-71. doi: 10.3109/13685538.2010.522277. Epub 2010 Oct 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile Function	International Index of Erectile Function - IIEF-5 index (range 0-25; higher better)	Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
Primary	Voiding Function	International Prostatic Symptoms Score - IPSS (range 0-35; higher worse)	Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
Primary	Beck scale	Beck Anxiety Index - BAI (0-63; higher worse)	Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
Primary	Emotional thermometers	Thermometer score (range 0-10; higher worse)	Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)