Prostate CancerNCT05965180
Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe
An observational study of Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Fine Needle Photoacoustic Probe
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with planned prostate biopsy procedures will be recruited through U-M Urology Clinics
Who may be able to join
- 1) Planned prostate biopsy as part of routine clinical care
- 2) > 40 and <80 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu
Guan Xu, Phd
About this study
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.
Read the detailed description
14AUG2024- enrollment was increased to 50 subjects
- Conditions
- Prostate Cancer
- Being tested
- Fine Needle Photoacoustic Probe
- Keywords
- Biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine Needle Photoacoustic ProbeDevice
Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fine Needle Photoacoustic Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of reliable measurements
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.
Measured: day 1
Secondary outcomes (1)
Determining the ability to observe differences between benign and cancerous regions
The secondary aim of this study is documenting our ability to observe differences between the PASA linear slope values derived from benign and cancerous regions, i.e., to detect the difference of 0.05 of 0.19, 0.17, 0.14, 0.20 dB/MHz between the means of the linear slopes in benign and cancerous regions at the wavelengths of 1220 nm, 1370 nm, 800 nm and 266 nm, respectively.
We will aim at differentiating the measurements in benign and cancerous regions at specific wavelengths. We have a null hypothesis for each wavelength that at this specific wavelength, our measurement cannot differentiate the benign and cancerous regions. We will test the hypothesis with paired t-tests.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start16 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Guan Xu, Phd, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965180
- Sponsor's protocol ID
- UMCC 2022.015
- Other IDs
- HUM00217834, R37CA222829
- Status last verified
- Nov 2025
- First submitted
- 27 Apr 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe
- ClinicalTrials.gov ID
- NCT05965180
- Acronym / sponsor ID
- UMCC 2022.015
- Conditions
- Prostate Cancer
- Keywords
- Biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
14AUG2024- enrollment was increased to 50 subjects
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy | – | Device: Fine Needle Photoacoustic ProbePatients 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with planned prostate biopsy procedures will be recruited through U-M Urology Clinics
Key inclusion criteria (2 listed)
- 1) Planned prostate biopsy as part of routine clinical care
- 2) > 40 and <80 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fine Needle Photoacoustic ProbeFine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction | Device | Biopsy |
Primary outcome
Demonstration of reliable measurements
Time frame: day 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.
1 secondary outcome
Determining the ability to observe differences between benign and cancerous regions
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guan Xu, Phd principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of reliable measurements (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.