Comparison of a Novel Transperineal Targeted Fusion Biopsy System to Conventional Transrectal Targeted Fusion Biopsy

Prostate Cancer Clinical Trial

Official title:

Comparison of a Novel Transperineal Targeted Fusion Biopsy System to Conventional Transrectal Targeted Fusion Biopsy for Diagnosis of Clinically Significant Prostate Cancers and to Eliminate Post-procedure Related Infections: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03936127
• Other study ID #: 20190262-01H
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: The Ottawa Hospital
• Contact: Nicola Schieda, MD
• Phone: 613-759-0958
• Email: nschieda[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed as a randomized control trial which intends to determine if transperineal (TP) targeted biopsy is not inferior to transrectal (TR) targeted biopsy for diagnosis of clinically significant prostate cancer while comparing post-procedural infection rates between the two techniques. The study will also look to compare patient reported pain scores related to the procedure, rates of other minor complications (e.g. bleeding, urinary retention) and procedure time. The expected sample size at The Ottawa Hospital is 360 men.

Description:

Patients undergo mp-MRI, at the discretion of the treating Urologist, when they are referred to the Cancer Assessment Clinic for their initial visit with a risk factor for prostate cancer (e.g. abnormal digital rectal exam [DRE] or elevated prostate serum antigen [PSA] level). Performing an mp-MRI in a man with risk factors for prostate cancer prior to an initial biopsy has become the standard of care for diagnosis of prostate cancer based on two large multi-center randomized control trials. At the second visit, which is standard of care, the Urologist (or delegate [Resident, Fellow]) will discuss targeted biopsy and will introduce the trial design obtaining informed consent to participate. If consent is obtained, the patient will be randomly assigned to receive either the standard transrectal (TR) ultrasound guided targeted fusion biopsy or the novel transperineal (TP) targeted fusion biopsy system which has also been preliminarily validated as being accurate for detection of significant prostate cancers at targeted biopsy. Patients will be notified regarding which method of targeted biopsy will be employed at time of scheduling. Both the TR and TP biopsies will be conducted in existing biopsy rooms in The Ottawa Hospital (TOH) and will employ a brief 30-minute post-procedural observation period at which point the patient is required to urinate prior to discharge. Level of pain will be recorded by the ultrasound technologists during the 30 minutes observation period as well. This study aims to compare ultrasound guided transrectal and transperineal targeted fusion biopsy for diagnosis of prostate cancer in abnormalities detected on MRI for the purpose of reducing or completely eliminating the risk of serious infection associated with the transrectal approach.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• MRI positive - abnormal area detected
• Patient re-evaluated in the TOH Prostate CAC (Cancer Assessment Centre) for planning of targeted biopsy
• Signed Consent

Exclusion Criteria:

• MRI negative - no abnormal area detected
• Patient with a prior diagnosis of prostate cancer enrolled in active surveillance

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Ultrasound (US) Targeted Fusion Biopsy
Ultrasound (US) Targeted Fusion Biopsy

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Nicola Schieda	The Ottawa Hospital Academic Medical Association

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20. — View Citation

Barrett T, Haider MA. The Emerging Role of MRI in Prostate Cancer Active Surveillance and Ongoing Challenges. AJR Am J Roentgenol. 2017 Jan;208(1):131-139. doi: 10.2214/AJR.16.16355. Epub 2016 Oct 11. Review. — View Citation

Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16. Review. — View Citation

Costa DN, Kay FU, Pedrosa I, Kolski L, Lotan Y, Roehrborn CG, Hornberger B, Xi Y, Francis F, Rofsky NM. An initial negative round of targeted biopsies in men with highly suspicious multiparametric magnetic resonance findings does not exclude clinically significant prostate cancer-Preliminary experience. Urol Oncol. 2017 Apr;35(4):149.e15-149.e21. doi: 10.1016/j.urolonc.2016.11.006. Epub 2016 Dec 9. — View Citation

Guo LH, Wu R, Xu HX, Xu JM, Wu J, Wang S, Bo XW, Liu BJ. Comparison between Ultrasound Guided Transperineal and Transrectal Prostate Biopsy: A Prospective, Randomized, and Controlled Trial. Sci Rep. 2015 Nov 3;5:16089. doi: 10.1038/srep16089. — View Citation

Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budäus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18. — View Citation

Kosarek CD, Mahmoud AM, Eyzaguirre EJ, Shan Y, Walser EM, Horn GL, Williams SB. Initial series of magnetic resonance imaging (MRI)-fusion targeted prostate biopsy using the first transperineal targeted platform available in the USA. BJU Int. 2018 Nov;122(5):909-912. doi: 10.1111/bju.14206. Epub 2018 Apr 14. — View Citation

Nam RK, Saskin R, Lee Y, Liu Y, Law C, Klotz LH, Loblaw DA, Trachtenberg J, Stanimirovic A, Simor AE, Seth A, Urbach DR, Narod SA. Increasing hospital admission rates for urological complications after transrectal ultrasound guided prostate biopsy. J Urol. 2013 Jan;189(1 Suppl):S12-7; discussion S17-8. doi: 10.1016/j.juro.2012.11.015. — View Citation

Oderda M, Faletti R, Battisti G, Dalmasso E, Falcone M, Marra G, Palazzetti A, Zitella A, Bergamasco L, Gandini G, Gontero P. Prostate Cancer Detection Rate with Koelis Fusion Biopsies versus Cognitive Biopsies: A Comparative Study. Urol Int. 2016;97(2):230-7. doi: 10.1159/000445524. Epub 2016 Jun 4. — View Citation

Rudzinski JK, Kawakami J. Incidence of infectious complications following transrectal ultrasound-guided prostate biopsy in Calgary, Alberta, Canada: A retrospective population-based analysis. Can Urol Assoc J. 2014 May;8(5-6):E301-5. doi: 10.5489/cuaj.1751. — View Citation

Schmit GD, Schenck LA, Thompson RH, Boorjian SA, Kurup AN, Weisbrod AJ, Kor DJ, Callstrom MR, Atwell TD, Carter RE. Predicting renal cryoablation complications: new risk score based on tumor size and location and patient history. Radiology. 2014 Sep;272(3):903-10. doi: 10.1148/radiol.14132548. Epub 2014 May 7. — View Citation

Verma S, Choyke PL, Eberhardt SC, Oto A, Tempany CM, Turkbey B, Rosenkrantz AB. The Current State of MR Imaging-targeted Biopsy Techniques for Detection of Prostate Cancer. Radiology. 2017 Nov;285(2):343-356. doi: 10.1148/radiol.2017161684. Review. — View Citation

Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eururo.2015.08.052. Epub 2015 Oct 1. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection Rate	Number of patients with or without post-procedural infection.	Patients who have undergone biopsy of the prostate will be seen by their Urologist in routine clinical follow-up, typically in 4-6 weeks, as per standard of care.
Secondary	Clinically Significant Prostate Cancer	Gleason score of tumor in biopsy samples containing cancer.	Patients who have undergone biopsy of the prostate will be seen by their Urologist in routine clinical follow-up, typically in 4-6 weeks, as per standard of care.

External Links

•   Canadian Cancer Society (2018) Canadian Cancer Statistics
•   Shen PF, Zhu YC, Wei WR et al (2012) The results of transperineal versus transrectal prostate biopsy: a systematic review and meta