Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men

NCT04108871 | Unknown

• 1 other identifier: UW18-392
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Tranperineal prostate biopsy(TPB) and Transrectal prostate biopsy(TRUSB) are now both routine diagnosis methods of prostate cancer in Queen Mary Hospital. The TRUSB has been the most common way to sample prostate tissue for decades. The TPB has been employed as one of our routine diagnosis methods in early 2018. The aim of this study is to evaluate whether Tranperineal prostate biopsy using a noval transperineal access system under local anaesthesia is non-inferior to standard 12-cores Transrectal prostate biopsy in detecting prostate cancer (PCa), in patients with clinical suspicion of PCa with no prior prostate biopsy.

Conditions

Prostate Cancer; Prostatic Hyperplasia

Keywords

Biopsy; Transperineal Prostate Biopsy; Prostate Cancer Detection; Transrectal Prostate Biopsy

Outcome Measures

Primary Outcomes (1)

• Detection rate of prostate cancer

  Absolute differences in PCa detection rate will be calculated with 95% CIs. If lower bound of 97.5% CI for the difference in cancer detection rates of LA TP biopsy compared with TRUS biopsy is greater than -5%, then TP biopsy will be deemed non-inferior. If lower bound is greater than 0, TP will be deemed superior.

  When histopathology results available, expected to be within 14 days following biopsy

Secondary Outcomes (10)

• Procedure tolerability

  Immediately following test

• General health-related quality of life

  Baseline and 30 days post-biopsy

• Quality of life concerning urinary symptoms

  Baseline and 30 days post-biopsy

• Quality of life concerning erectile function

  Baseline and 30 days post-biopsy

• Rate of procedure induced sepsis

  1 week to 30 days post-biopsy

Study Arms (2)

Transperineal Prostate Biopsy

EXPERIMENTAL

The biopsy needed is inserted to the prostate through the perineal skin, with the assistance of an access system device known as PrecisionPoint. It utilises a single access needle cannula mounted directly on to the ultrasound probe, which acts as an access point traversing through the perineal skin. 4 - 5 cores are obtained from the anterior, mid and posterior zone of each side of the prostate.

Procedure: Prostate Biopsy

Transrectal Prostate Biopsy

ACTIVE COMPARATOR

The biopsy needle penetrates through the bowel (rectum) to the prostate to obtain 12 cores of prostate tissues from the lateral and medial base, midzone and apex of each side of the prostate (1 core each).

Procedure: Prostate Biopsy

Interventions

Prostate Biopsy PROCEDURE

Samples of tissue are removed from the prostate for histopathological diagnosis of prostate cancer through the use of a needle with the assistance of transrectal ultrasound.

Transperineal Prostate Biopsy; Transrectal Prostate Biopsy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serum PSA larger or equal to 20ng/mL
• Suspected tumour clinical stage T2 on DRE
• No previous history of prostate biopsy
• Medically fit to undergo procedures according to study protocol

You may not qualify if:

• Patients who are unable to provide written informed consent
• Known history of prostate cancer
• Contraindication to prostate biopsy
• Had pre-biopsy mpMRI
• Rectal abnormality precluding transrectal ultrasound

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Division of Urology, Department of Surgery, Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (8)

• Hsing AW, Tsao L, Devesa SS. International trends and patterns of prostate cancer incidence and mortality. Int J Cancer. 2000 Jan 1;85(1):60-7. doi: 10.1002/(sici)1097-0215(20000101)85:13.0.co;2-b.

  PMID: 10585584 BACKGROUND

• Klotz L. Active surveillance for low-risk prostate cancer. Curr Urol Rep. 2015 Apr;16(4):24. doi: 10.1007/s11934-015-0492-z.

  PMID: 25764118 BACKGROUND

• Hodge KK, McNeal JE, Terris MK, Stamey TA. Random systematic versus directed ultrasound guided transrectal core biopsies of the prostate. J Urol. 1989 Jul;142(1):71-4; discussion 74-5. doi: 10.1016/s0022-5347(17)38664-0.

  PMID: 2659827 BACKGROUND

• Presti JC Jr, O'Dowd GJ, Miller MC, Mattu R, Veltri RW. Extended peripheral zone biopsy schemes increase cancer detection rates and minimize variance in prostate specific antigen and age related cancer rates: results of a community multi-practice study. J Urol. 2003 Jan;169(1):125-9. doi: 10.1016/S0022-5347(05)64051-7.

  PMID: 12478119 BACKGROUND

• Nakai Y, Tanaka N, Anai S, Miyake M, Hori S, Tatsumi Y, Morizawa Y, Fujii T, Konishi N, Fujimoto K. Transperineal template-guided saturation biopsy aimed at sampling one core for each milliliter of prostate volume: 103 cases requiring repeat prostate biopsy. BMC Urol. 2017 Apr 5;17(1):28. doi: 10.1186/s12894-017-0219-1.

  PMID: 28381267 BACKGROUND

• Falzarano SM, Zhou M, Hernandez AV, Moussa AS, Jones JS, Magi-Galluzzi C. Can saturation biopsy predict prostate cancer localization in radical prostatectomy specimens: a correlative study and implications for focal therapy. Urology. 2010 Sep;76(3):682-7. doi: 10.1016/j.urology.2009.11.067. Epub 2010 Mar 5.

  PMID: 20206973 BACKGROUND

• Tsu JH, Ma WK, Chan WK, Lam BH, To KC, To WK, Ng TK, Liu PL, Cheung FK, Yiu MK. Prevalence and predictive factors of harboring fluoroquinolone-resistant and extended-spectrum beta-lactamase-producing rectal flora in Hong Kong Chinese men undergoing transrectal ultrasound-guided prostate biopsy. Urology. 2015 Jan;85(1):15-21. doi: 10.1016/j.urology.2014.07.078. Epub 2014 Nov 8.

  PMID: 25444632 BACKGROUND

• Meyer AR, Joice GA, Schwen ZR, Partin AW, Allaf ME, Gorin MA. Initial Experience Performing In-office Ultrasound-guided Transperineal Prostate Biopsy Under Local Anesthesia Using the PrecisionPoint Transperineal Access System. Urology. 2018 May;115:8-13. doi: 10.1016/j.urology.2018.01.021. Epub 2018 Feb 1.

  PMID: 29409845 BACKGROUND

Related Links

• Prostate cancer incidence statistics. Cancer research UK. London, United Kingdom: cancer research 2014.
• The Hong Kong cancer registry. Hospital Authority, Hong Kong.
• 11\. United States Food and Drug Adminstration Approval of PrecisionPoint Transperineal Access System.

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Wayne Lam

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Assistant

CONTACT

852-22554852; stac@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: September 30, 2019
• Study Start: October 3, 2018
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

HK (1)