Recruiting

Transperineal vs. Transrectal

Sponsor:

Dr. Nicola Schieda

Code:

NCT03936127

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Ultrasound (US) Targeted Fusion Biopsy

Study Details

Brief 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.

Conditions

Prostate Cancer

Study ID

NCT03936127

Start date

Oct 11, 2022

Status verified date

Oct, 2022

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Transperineal (TP) Ultrasound (US) Targeted Fusion Biopsy

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

active comparator: Transrectal (TR) Ultrasound (US) Targeted Fusion Biopsies

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

Interventions

Ultrasound (US) Targeted Fusion Biopsy

Ultrasound (US) Targeted Fusion Biopsy

Primary outcome measure

  • Infection Rate [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Nicola Schieda, MD

613-759-0958nschieda@toh.ca

Betty Anne Schwarz, PhD

613-798-5555baschwarz@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

Contacts

Nicola Schieda, MD

613-759-0958nschieda@toh.ca

Betty Anne Schwarz, PhD

613-798-5555baschwarz@toh.ca

More Information

Sponsor

Dr. Nicola Schieda

Last update posted

Oct 25, 2022

Last verified

Oct, 2022

Keywords

  • Transperineal
  • Transrectal
  • Fusion Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Nicola Schieda on 2022-10-25.