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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
ProBE-PC Trial 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.Check my eligibility
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.See study design
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.
ProBE-PC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a prostate biopsy to check for cancer.
ProBE-PC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinically significant cancer detection rate
Rate of infectious complications
Secondary outcome measures
Cost of the procedures
Patient reported sexual function measures using IIEF questionaire
Patient reported urinary function measures using IPSS questionaire
+2 moreProBE-PC 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
91 Previous Clinical Trials
10,657 Total Patients Enrolled
1 Trials studying Infections
602 Patients Enrolled for Infections
Badar M Mian, MDPrincipal InvestigatorAlbany Medical College
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot access my rectum due to past surgery.My upcoming procedure needs me to be sedated or under general anesthesia.I am scheduled for a prostate biopsy to check for cancer.I have no skin infections or abnormalities in the perineal area.
Research Study Groups:
This trial has the following groups:- Group 1: Systematic Transrectal biopsy (TR-Bx)
- Group 2: Targeted Transrectal biopsy (TR-Bx)
- Group 3: Systematic Transperineal biopsy (TP-Bx)
- Group 4: Targeted Transperineal biopsy (TP-Bx)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What site did they apply to?
Albany Medical College
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
interested in new technique.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Recent research and studies
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