Recruiting

Observational Study

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT05965180

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Fine Needle Photoacoustic Probe

Study Details

Brief summary:

In this project, we will integrate the Photoacoustic (PA) technology into a prostate biopsy procedure through a fine needle probe. The needle probe will be in the shape of a biopsy needle and compatible with the needle insertion mechanism in the transrectal ultrasound (TRUS) probe. When inserted into the prostate, the fine needle PA probe will assess the histological information in its surrounding tissue without any tissue extraction. The needle probe has been tested in prostate tissue samples and whole human prostates ex vivo.

Conditions

Prostate Cancer

Study ID

NCT05965180

Start date

Oct 16, 2023

Status verified date

Nov, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Biopsy

Patients will be identified once prostate biopsies have been scheduled. Once enrolled on trial, patients will undergo standard biopsy procedure as per clinical care. During this biopsy, research measurements will be completed using the fine needle photoacoustic probe.

Interventions

Fine Needle Photoacoustic Probe

Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction

Primary outcome measure

  • Demonstration of reliable measurements [ Time Frame: day 1 ]

Central Contacts and Locations

Central contacts

Cancer AnswerLine

1-800-865-1125CancerAnswerLine@med.umich.edu

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer AnswerLine

800-865-1125CancerAnswerLine@med.umich.edu

Principal Investigator:

Guan Xu, Phd

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2025-11-24.