Clinical trial NCT02825225: A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes
Official title: A Randomized Controlled Trial To Assess and Compare the Outcomes of 20-core Versus 12-core Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Local Anesthesia
Prostate-Specific Antigen/Blood
Biopsy/Methods
Image-guided Biopsy/Methods
Prostatic Neoplasms/Diagnosis
Prostate/Pathology
Prospective Studies
Humans
Male
Ultrasonography, Interventional/Methods
Keywords: Prostatic Neoplasms
Biopsy
Anesthesia
Detection
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Hospital Brigadeiro UGA V-SP
First posted: 2016-07-07
Enrollment: 750
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose is to compare the detection rate of 20-core versus 12-core prostate biopsy. The secondary objective is to evaluate pain perception using a validated scale to compare the analgesia provided by the two different local anesthesia schemes. Data will be prospectively collected from patients who will undergo prostate biopsy in a single high volume urology center. The patients will be randomized to two different biopsy samplings and two local anesthesia schemes.

Detailed description: Prostate cancer is male's leading solid non-cutaneous tumor, and the second cause of cancer death in western countries. The main risk factors are age (5th decade or more), family history and life-style (low physical activity and occidental dietary habit). Due to it's high incidence and mortality, the screening protocols continue to be supported worldwide by the urologic and oncologic societies. The diagnosis of this disease needs histological evidence that is obtained by prostate biopsy which is indicated when prostate specific antigen (PSA) serum levels are elevated or there is suspicion at digital rectal examination. Actual estimations conclude that more than 200.000 new cases are diagnosed per-year in US and much more patients are submitted to biopsies; turning prostate biopsy a routine medical procedure. In therms of current medical evidence there is controversy in some biopsy aspects. The ideal number of fragments to be obtained is not well established. While twelve core is believed to be the minimum to be sampled, the maximum number is not clear. To ease the estimation of the number of necessary core at biopsy the literature recommend the use of nomograms; they adequate the number of removed fragments according to each individual characteristics such as age, volume, previous biopsy and PSA levels. The prostate biopsy is considered a painful procedure by 96% of patients, therefore it is fundamental to soften the soreness employing some form of anesthesia. There is no consensus regarding the ideal protocol but the local anesthesia with the periprostatic blockade is the most employed worldwide. However there is a controversy related to the site of the injection during the periprostatic block in terms of efficacy: base versus apex or both sites.

Considering the epidemiological importance of prostate cancer detection in a continuous aging population, this study protocol was enrolled in a single center high volume urology Brazilian Public Hospital. The patients will be randomized at a 1:1 ratio for the two biopsy schemes and for the two anesthesia templates.The main objective was to compare the detection rate of two different prostate biopsy schemes 20-core versus 12-core prostate biopsy guided by transrectal ultrasound. Secondary objectives were to evaluate pain perception of the two local anesthesia schemes using a validated pain scale. The pain was evaluated using the visual pain scale immediately after the biopsy and one hour after the procedure. The patients were contacted by phone one week after the biopsy to assess the occurrence of any complication. The investigators then compared the major and minor complication rates of 20-core versus 12-core protocol using the Clavien-Dindo scale. In those patients with cancer at the pathologic report that underwent radical prostatectomy, the investigators will also compare the concordance of Gleason score between the biopsy versus surgical specimen according to the biopsy scheme 20-core versus 12-core.

Data was collected since mid 2012 up to june 2016, inclusion and exclusion criteria will be detailed elsewhere. All information was obtained by the main investigator and all procedures were supervised by the main investigator as well.

Eligibility criteria: Inclusion Criteria:

* Formal indication to prostate biopsy: PSA elevation, positive digital rectal examination of prostate, prostate cancer active surveillance protocols.
* Patients signing the consent therm agreeing to participate in the trial
* Exclusive local anesthesia prostate biopsy.
* Exclusive transrectal ultrasound guided prostate biopsy.

Exclusion Criteria:

* Transperineal ultrasound guided prostate biopsy
* Magnetic resonance cognitive fusion biopsy.
* Previous treatment with radiation therapy or brachytherapy.
* Previous treatment with focal therapy
* Previous androgen deprivation therapy

Primary outcomes:
measure: Number of participants with prostate cancer detected.
timeFrame: Through study completion, an average of four years.
Secondary outcomes:
measure: Number of participants with complications
timeFrame: Immediate, early (30 minutes) and late (within first week)
measure: Core biopsy accuracy.
timeFrame: Through study completion, at time of surgery.
measure: Pain perception using pain analogue scale.
timeFrame: Immediate and early (30 minutes after biopsy).
measure: Number of participants with prostate cancer detected according to PSA value
timeFrame: Through study completion, an average of four years.
measure: Number of participants with prostate cancer detected according to PSA density.
timeFrame: Through study completion, an average of four years.
measure: Number of participants with prostate cancer detected according to free/total PSA ratio.
timeFrame: Through study completion, an average of four years.
measure: Number of participants with prostate cancer detected according to prostate volume.
timeFrame: Through study completion, an average of four years.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Brigadeiro UGA V-SP
Study officials:
affiliation: University of Nove de Julho
name: Jose Pontes Jr, MD PhD
role: PRINCIPAL_INVESTIGATOR
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