Prostate CancerNCT07690462
Infrared Fluorescence Staining Versus Frozen Section for Prostate Cancer Surgery
An observational study of Prostate Cancer, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study aims to validate the accuracy of the infrared fluorescence rapid detection technique for the diagnosis of prostate biopsy specimens, and to compare it with intraoperative frozen section and conventional paraffin section (the gold standard), so as to evaluate its feasibility and value in clinical application. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Dec 2027
- 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 18 years and older
- Men only
- Adult, Older adult
Study population: The study population consists of adult male patients scheduled for prostate biopsy at Xiangya Hospital's Department of Urology. Participants must be in a generally stable condition to tolerate the procedure and have no significant comorbidities that would interfere with study assessments or pose additional risks.
Who may be able to join
- All adult male patients who are scheduled to undergo prostate biopsy at the Department of Urology, Xiangya Hospital due to clinical suspicion (e.g., elevated PSA, abnormal digital rectal examination, or suspicious lesions on imaging).
- Patients whose cardiac, pulmonary, hepatic, renal, and coagulation functions are essentially normal and who are able to tolerate the biopsy procedure.
- The patient or their legally authorized representative has signed the written informed consent form.
Who cannot join
- Patients in the acute infection phase or febrile period.
- Patients with severe bleeding tendency conditions who are unable to undergo biopsy.
- Patients with any serious concomitant disease that, in the investigator's opinion, may interfere with the study results or increase the patient's risk (e.g., hypertensive crisis; decompensated cardiac insufficiency; severe internal or external hemorrhoids, perianal or rectal lesions, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Yi Cai, Doctor, +8673184327919, xyyyllwyh@126.com
About this study
Official title: A Clinical Validation Study of Novel Infrared Fluorescence Rapid Staining Versus Conventional Frozen Section in Intraoperative Diagnosis of Prostate Cancer
This study aims to validate the accuracy of the infrared fluorescence rapid detection technique for the diagnosis of prostate biopsy specimens, and to compare it with intraoperative frozen section and conventional paraffin section (the gold standard), so as to evaluate its feasibility and value in clinical application.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Novel infrared fluorescence rapid staining group | Not described | |
| Frozen section group | Not described | |
| Paraffin section group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of prostate biopsy specimens
To evaluate the diagnostic accuracy of the novel rapid infrared fluorescence staining technique for prostate biopsy specimens, and to compare it with frozen section.
Measured: At baseline (Single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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 Xiangya Hospital of Central South UniversityThe 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
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690462
- Sponsor's protocol ID
- 2026040848
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Validation Study of Novel Infrared Fluorescence Rapid Staining Versus Conventional Frozen Section in Intraoperative Diagnosis of Prostate Cancer
- ClinicalTrials.gov ID
- NCT07690462
- Acronym / sponsor ID
- 2026040848
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Jul 2026 (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.
This study aims to validate the accuracy of the infrared fluorescence rapid detection technique for the diagnosis of prostate biopsy specimens, and to compare it with intraoperative frozen section and conventional paraffin section (the gold standard), so as to evaluate its feasibility and value in clinical application.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Novel infrared fluorescence rapid staining group | – | – |
| Frozen section group | – | – |
| Paraffin section group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult male patients scheduled for prostate biopsy at Xiangya Hospital's Department of Urology. Participants must be in a generally stable condition to tolerate the procedure and have no significant comorbidities that would interfere with study assessments or pose additional risks.
Key inclusion criteria (3 listed)
- All adult male patients who are scheduled to undergo prostate biopsy at the Department of Urology, Xiangya Hospital due to clinical suspicion (e.g., elevated PSA, abnormal digital rectal examination, or suspicious lesions on imaging).
- Patients whose cardiac, pulmonary, hepatic, renal, and coagulation functions are essentially normal and who are able to tolerate the biopsy procedure.
- The patient or their legally authorized representative has signed the written informed consent form.
Key exclusion criteria (3 listed)
- Patients in the acute infection phase or febrile period.
- Patients with severe bleeding tendency conditions who are unable to undergo biopsy.
- Patients with any serious concomitant disease that, in the investigator's opinion, may interfere with the study results or increase the patient's risk (e.g., hypertensive crisis; decompensated cardiac insufficiency; severe internal or external hemorrhoids, perianal or rectal lesions, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of prostate biopsy specimens
Time frame: At baseline (Single visit)
To evaluate the diagnostic accuracy of the novel rapid infrared fluorescence staining technique for prostate biopsy specimens, and to compare it with frozen section.
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 8 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 Xiangya Hospital of Central South University at 1 site in China.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 8 Jul 2026. 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 China. 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 Yi Cai (+8613637310713, cai-yi@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of prostate biopsy specimens (time frame: At baseline (Single visit)). 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 8 Jul 2026.