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Which prostate biopsy method is safer and better at finding cancer?

NCT ID NCT04081636

Knowledge-focused Sponsor: Albany Medical College Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two common methods for taking a prostate biopsy: one through the rectal wall and one through the skin between the scrotum and anus. 840 men who needed a biopsy for suspected prostate cancer were randomly assigned to one of the two methods. The goal was to see which approach causes fewer infections and detects more significant cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this trial succeeds, doctors may know which biopsy method is safer and more accurate for diagnosing prostate cancer.
What could go wrong
This is a completed study comparing two standard procedures, not a new treatment. Results may not change practice if neither method is clearly superior.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

840 people

The number who actually took part.

Started

Sep 2019

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Patients with no access to rectum (due to previous rectal surgery) * Any abnormalities of the perineal skin (e.g. infection) * Patients whose procedure requires sedation or general anesthesia

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Conditions

The condition(s) this trial relates to.

Hemorrhage Infections infectious disease pleomorphic adenoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infection Prostate cancer PSA

Contacts and locations

Locations

  • Albany Medical College

    Albany, New York, 12208, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.