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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

Primary Purpose

Prostate Cancer, Prostatic Hyperplasia

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Prostate Biopsy
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Biopsy, Transperineal Prostate Biopsy, Prostate Cancer Detection, Transrectal Prostate Biopsy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Division of Urology, Department of Surgery, Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transperineal Prostate Biopsy

Transrectal Prostate Biopsy

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Procedure tolerability
The pain score of the procedure reported by patient
General health-related quality of life
EQ-5D-5L
Quality of life concerning urinary symptoms
International Prostate Symptom Score (I-PSS)
Quality of life concerning erectile function
International Index of Erectile Function (IIEF)
Rate of procedure induced sepsis
Detection rates of patients with clinically significant PCa
Ca Prostate with Gleason score larger or equal to 3+4
Maximum cancer core length (MCCL, mm)
Proportion of men go on to undergo definitive curative treatment for local disease (including surgery and radiotherapy)
Procedure times (minutes)
Time from start of ultrasound probe insertion to probe removal
Cost per diagnosis of cancer (HKD)
The cost of each diagnosis based on the equipment, manpower and medication

Full Information

First Posted
May 14, 2019
Last Updated
September 27, 2019
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04108871
Brief Title
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
Official Title
Randomized-controlled Trial: 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The incidence of prostate cancer (PCa) has increased considerably in recent years [1, 2]. The reported lifetime risk for men in Hong Kong to be diagnosed with PCa is 1 in 31 before the age of 75, and is currently the third commonest cancer Hong Kong men according to the Hong Kong Cancer Registry [3]. This highlights the importance of thorough and fundamentally a safe investigation technique to correctly identify patients with PCa. Such test should be able to sensitively detect PCa, and provide early diagnosis. Critically, such test is required to provide accurate disease risk stratification, which is absolutely crucial in guiding level of appropriate treatment is necessary in patients diagnosed with PCa. According to recommendations from the National Institute for Health and Care Excellence (NICE) guidelines, current standard clinical practice considers histological diagnosis of PCa a necessity in majority of patients presented with localized disease who are eligible for treatment [4]. This, alongside with prostate specific antigen (PSA) level, digital rectal examination (DRE) findings, and increasingly the use of multi-parametric MRI (mpMRI) imaging, collectively allows risk stratification of PCa. The current pathway to obtain prostate tissue for histological diagnosis of CaP is by transrectal ultrasound-guided systematic biopsy (TRUSB) of the prostate, usually following the detection of a raised serum PSA level and/or suspicious rectal examination findings. TRUSB has been the standard prostate tissue sampling technique for men suspected with PCa for over 30 years. It is an office-based procedure carried out under local anaesthesia (LA), with 10 to 12 biopsy cores directed towards the lateral peripheral zones of the prostate thought to harbour majority of cancers [7]. However, there are still various well-known cancer detection limitations and patient safety problems associated with TRUSB. Firstly, a very significant portion of tumours are being missed with the TRUSB technique [8]. It has been well- known that over 30% of patients with low risk PCa on TRUSB have been found to harbour clinically significant PCa [9]. Many of these tumours missed on TRUSB are located in the anterior and apical regions of the prostate, which TRUSB is difficult to access, in particular in patients with a large prostate volume Secondly, TRUSB requires the biopsy needle to penetrate through the bowel (rectum). This results in high risk of developing sepsis following biopsy, despite all patients undergoing the procedure being started on antibiotics prophylactically. This is a serious complication which can potentially be life-threatening. Our previous study has already demonstrated a high prevalence of fluoroquinolone-resistant and ESBL-producing rectal flora in our local population in Hong Kong [10]. The risk of developing post-biopsy sepsis in Hong Kong is high. Transperineal prostate biopsy (TPB) has been developed to provide a more comprehensive biopsy method to improve cancer detection rate by directing biopsy cores through the perineal skin. Theoretically, TPB enables access to sample the entire prostate, in particular the anterior and apical regions which are not easily accessible through the standard TRUSB method. By sampling the prostate using biopsy needles directly inserted through the perineal skin rather than bowel, the risk of sepsis is reduced. However, this technique requires multiple needles traversing through the perineum, and requires to be carried out under general anaesthesia (GA). Another disadvantage is a stabilising stepping unit is required to provide a consistent alignment of the ultrasound probe against the prostate in order to carry out the biopsies. Such stabilising stepping units are costly. A novel but simple transperineal access system device known as PrecisionPoint (Perineologic, Cumberland, MD, USA) has been developed to tackle the aforementioned limitations of TPB. This revolutionary device utilises a single access needle cannula mounted directly on to the ultrasound probe, which acts as an access point traversing through the perineal skin. This design minimises the number of needle punctures through the skin, enabling TPB to be carried out under LA. A stabilising stepping unit is not required with this technique. The device has gained the United States Food and Drug Administration (FDA) approval [11], and results from small contemporary series have already been published with very promising results in terms of cancer detection rate and safety [12]. TRUSB has a poor cancer detection rate and is associated with potentially fatal septic risk. TPB, if able to be carried out under LA as an office-based procedure, can potentially provide a better cancer detection rate with significantly reduced sepsis risk. It has fundamentally a very high potential to become the new gold standard in obtaining prostate tissue for histological diagnosis of PCa. With an increasing number of men in Hong Kong with elevated serum PSA suspicion of PCa needing prostate biopsy, it is fundamental to carry out a study to determine the most effective, safe and tolerable prostate biopsy technique which fits with the clinical practice in Hong Kong.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostatic Hyperplasia
Keywords
Biopsy, Transperineal Prostate Biopsy, Prostate Cancer Detection, Transrectal Prostate Biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transperineal Prostate Biopsy
Arm Type
Experimental
Arm Description
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.
Arm Title
Transrectal Prostate Biopsy
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Prostate Biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detection rate of prostate cancer
Description
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.
Time Frame
When histopathology results available, expected to be within 14 days following biopsy
Secondary Outcome Measure Information:
Title
Procedure tolerability
Description
The pain score of the procedure reported by patient
Time Frame
Immediately following test
Title
General health-related quality of life
Description
EQ-5D-5L
Time Frame
Baseline and 30 days post-biopsy
Title
Quality of life concerning urinary symptoms
Description
International Prostate Symptom Score (I-PSS)
Time Frame
Baseline and 30 days post-biopsy
Title
Quality of life concerning erectile function
Description
International Index of Erectile Function (IIEF)
Time Frame
Baseline and 30 days post-biopsy
Title
Rate of procedure induced sepsis
Time Frame
1 week to 30 days post-biopsy
Title
Detection rates of patients with clinically significant PCa
Description
Ca Prostate with Gleason score larger or equal to 3+4
Time Frame
When histopathology results available, expected to be within 14 days following biopsy
Title
Maximum cancer core length (MCCL, mm)
Time Frame
When histopathology results available, expected to be within 14 days following biopsy
Title
Proportion of men go on to undergo definitive curative treatment for local disease (including surgery and radiotherapy)
Time Frame
After treatment decision, expected to be within 30 days following biopsy
Title
Procedure times (minutes)
Description
Time from start of ultrasound probe insertion to probe removal
Time Frame
During test
Title
Cost per diagnosis of cancer (HKD)
Description
The cost of each diagnosis based on the equipment, manpower and medication
Time Frame
30 days post-biopsy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Assistant
Phone
852-22554852
Email
stac@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Lam
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Urology, Department of Surgery, Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Assistant
Phone
22554852
Email
stac@hku.hk
First Name & Middle Initial & Last Name & Degree
Wayne Lam, MBBS(Lond)

12. IPD Sharing Statement

Citations:
PubMed Identifier
10585584
Citation
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.
Results Reference
background
PubMed Identifier
25764118
Citation
Klotz L. Active surveillance for low-risk prostate cancer. Curr Urol Rep. 2015 Apr;16(4):24. doi: 10.1007/s11934-015-0492-z.
Results Reference
background
PubMed Identifier
2659827
Citation
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.
Results Reference
background
PubMed Identifier
12478119
Citation
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.
Results Reference
background
PubMed Identifier
28381267
Citation
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.
Results Reference
background
PubMed Identifier
20206973
Citation
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.
Results Reference
background
PubMed Identifier
25444632
Citation
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.
Results Reference
background
PubMed Identifier
29409845
Citation
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.
Results Reference
background
Links:
URL
http://www3.ha.org.hk/cancereg/topten.html
Description
The Hong Kong cancer registry. Hospital Authority, Hong Kong.
URL
http://www.accessdata.fda.gov/cdrh_docs/pdf16/k160414.pdf
Description
11. United States Food and Drug Adminstration Approval of PrecisionPoint Transperineal Access System.

Learn more about this trial

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

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