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Observational Study of Fine Needle Photoacoustic Probe for Prostate Cancer

This study is looking at a new tool called the Fine Needle Photoacoustic Probe for men with prostate cancer. This probe is designed to be used during a standard prostate biopsy. It works by assessing the tissue around it without taking out any tissue samples. The goal is to see if this probe can reliably measure information about the prostate tissue. You might be able to join if you are a man between 40 and 80 years old and are already scheduled for a prostate biopsy. The study is currently enrolling 50 participants.

Study design
This is an observational study, meaning researchers will be watching and recording information. It plans to include 50 participants.
What's involved
The Fine Needle Photoacoustic Probe will be used during your planned prostate biopsy procedure.
Compensation
Not stated in the trial record.
Follow-up
Reliable measurements are assessed at day 1.

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NCT05965180

Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe

Recruiting
Not specifiedAges 40–80Observational
University of Michigan Rogel Cancer Center
~50 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:Fine Needle Photoacoustic Probe

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demonstration of reliable measurements
Measured over day 1

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Guan Xu, Phd · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Cancer AnswerLine
[email protected]
1-800-865-1125
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

1\) Planned prostate biopsy as part of routine clinical care
2\) \> 40 and \<80 years old

Exclusion

1\) Known history of bleeding disorders or
2\) Patients taking anticoagulants, no matter doses or washout time
3\) Known allergy to silicone material
4\) Unable to provide informed consent
5\) Either the surgeon or the patient do not think the patient will not be able to complete all parts of the study, the patient will be excluded
6\) Involved in other investigational studies.

What this trial measures

  • Demonstration of reliable measurementsday 1

    The primary aim of this study is to demonstrate that our fine needle PA probe can acquire reliable measurements of prostate glands. This will be indicated by a signal-to-noise ratio of the measurements that is larger than one. We will calculate the signal to noise ratio of the signals as the peak-to-peak signal magnitude over the amplitude of the system background signal. The technical failure is that we will not be able to achieve measurements with signal-to-noise ratios larger than 1 in 10% of the measurements. We will have a futility analysis after first 5 patients are completed (thus 10 measurements). If of those 10 measurements, 2 have a SNR less 1, then the study will be stopped as it is unlikely to meet its 90% target.