Transperineal (TP) Ultrasound (US) Targeted Fusion Biopsy for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate CancerUltrasound (US) Targeted Fusion Biopsy - Procedure
Eligibility
Any Age
Male
What conditions do you have?
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Study 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.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 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.

Week 6
Malignant neoplasm of prostate
Infection Rate

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Transrectal (TR) Ultrasound (US) Targeted Fusion Biopsies
1 of 2
Transperineal (TP) Ultrasound (US) Targeted Fusion Biopsy
1 of 2

Active Control

Experimental Treatment

360 Total Participants · 2 Treatment Groups

Primary Treatment: Transperineal (TP) Ultrasound (US) Targeted Fusion Biopsy · No Placebo Group · N/A

Transperineal (TP) Ultrasound (US) Targeted Fusion Biopsy
Procedure
Experimental Group · 1 Intervention: Ultrasound (US) Targeted Fusion Biopsy · Intervention Types: Procedure
Transrectal (TR) Ultrasound (US) Targeted Fusion Biopsies
Procedure
ActiveComparator Group · 1 Intervention: Ultrasound (US) Targeted Fusion Biopsy · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

The Ottawa Hospital Academic Medical AssociationOTHER
18 Previous Clinical Trials
2,051 Total Patients Enrolled
Dr. Nicola SchiedaLead Sponsor
Nicola Schieda, MDPrincipal InvestigatorThe Ottawa Hospital

Eligibility Criteria

Age Any Age · Male Participants · 3 Total Inclusion Criteria

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References