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Transrectal vs. Transperineal Biopsy for Prostate Cancer (ProBE-PC Trial)

N/A
Recruiting
Led By Badar M Mian, MD
Research Sponsored by Albany Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care either with or without an MRI
Must not have
Patients with no access to rectum (due to previous rectal surgery)
Patients whose procedure requires sedation or general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will help determine if transrectal or transperineal prostate biopsy is better in reducing complications and improving cancer detection.

Who is the study for?
Men needing a prostate biopsy due to suspected cancer, who can undergo the procedure without sedation or general anesthesia. They must have access to their rectum (no prior surgery blocking it) and no perineal skin abnormalities like infections.
What is being tested?
The study is comparing two methods of prostate biopsy: transrectal (needle through the rectal wall) and transperineal (needle through the skin). Participants will be randomly assigned to one of these methods to see which is more effective and has fewer complications.
What are the potential side effects?
Potential side effects include pain at the biopsy site, bleeding, infection risk from needle entry, urinary issues, and possibly temporary difficulty with sexual function. The severity of side effects may vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a prostate biopsy to check for cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot access my rectum due to past surgery.
Select...
My upcoming procedure needs me to be sedated or under general anesthesia.
Select...
I have no skin infections or abnormalities in the perineal area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinically significant cancer detection rate
Rate of infectious complications
Secondary study objectives
Cost of the procedures
Patient reported sexual function measures using IIEF questionaire
Patient reported urinary function measures using IPSS questionaire
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Targeted Transperineal biopsy (TP-Bx)Experimental Treatment1 Intervention
MRI-guided; needle inserted directly through the skin to reach the prostate
Group II: Systematic Transperineal biopsy (TP-Bx)Experimental Treatment1 Intervention
Ultrasound guided; needle inserted directly through the skin to reach the prostate
Group III: Systematic Transrectal biopsy (TR-Bx)Active Control1 Intervention
Ultrasound guided; needle inserted through the rectum to reach the prostate
Group IV: Targeted Transrectal biopsy (TR-Bx)Active Control1 Intervention
MRI-guided; needle inserted through the rectum to reach the prostate

Find a Location

Who is running the clinical trial?

Albany Medical CollegeLead Sponsor
93 Previous Clinical Trials
11,637 Total Patients Enrolled
1 Trials studying Infections
602 Patients Enrolled for Infections
Badar M Mian, MDPrincipal InvestigatorAlbany Medical College
1 Previous Clinical Trials
1,306 Total Patients Enrolled

Media Library

Systematic Transperineal biopsy (TP-Bx) Clinical Trial Eligibility Overview. Trial Name: NCT04081636 — N/A
Infections Research Study Groups: Systematic Transrectal biopsy (TR-Bx), Targeted Transrectal biopsy (TR-Bx), Systematic Transperineal biopsy (TP-Bx), Targeted Transperineal biopsy (TP-Bx)
Infections Clinical Trial 2023: Systematic Transperineal biopsy (TP-Bx) Highlights & Side Effects. Trial Name: NCT04081636 — N/A
Systematic Transperineal biopsy (TP-Bx) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04081636 — N/A
~13 spots leftby Dec 2024
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