Targeted Fusion Biopsy Techniques for Prostate Cancer

N/A

Recruiting

Led By Nicola Schieda, MD

Research Sponsored by Dr. Nicola Schieda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Patient with a prior diagnosis of prostate cancer enrolled in active surveillance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trialwill compare TP vs TR prostate cancer biopsies to see if one is better at diagnosing cancer, while looking at infection/pain/complication rates & procedure time. Expected sample size: 360 men.

Who is the study for?

This trial is for men who have an abnormal area detected on MRI, suggesting possible prostate cancer. They must have signed a consent form and been re-evaluated at The Ottawa Hospital's Prostate Cancer Assessment Centre. Men already diagnosed with prostate cancer under active surveillance or those with no abnormalities on MRI cannot participate.

What is being tested?

The study compares two biopsy methods to diagnose clinically significant prostate cancer: transperineal (TP) targeted fusion biopsy versus the conventional transrectal (TR) targeted fusion biopsy. It aims to see if TP is just as good as TR while also looking at infection rates, pain levels, other minor complications like bleeding or urinary issues, and how long the procedure takes.

What are the potential side effects?

Potential side effects from both biopsy techniques may include discomfort or pain during and after the procedure, risk of infection following the procedure, minor bleeding, difficulty urinating temporarily (urinary retention), among others.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am being actively monitored for prostate cancer without immediate treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Infection Rate

Secondary study objectives

Malignant neoplasm of prostate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Transperineal (TP) Ultrasound (US) Targeted Fusion BiopsyExperimental Treatment1 Intervention

Transperineal (TP) ultrasound (US) targeted fusion biopsy (which is performed using a validated Health Canada approved elastic software fusion platform).

Group II: Transrectal (TR) Ultrasound (US) Targeted Fusion BiopsiesActive Control1 Intervention

Transrectal (TR) ultrasound (US) targeted fusion biopsy (which is performed using a validated Health Canada approved elastic software fusion platform).

0 / 1Eligibility criteria met