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Can surgeons diagnose and remove prostate cancer in a single operation?

NCT ID NCT07819760

Diagnosis Sponsor: Botkin Hospital 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

This pilot study tests a one-stage approach for men with a high probability of clinically significant prostate cancer. Instead of a separate preoperative biopsy, participants have a targeted prostate biopsy under general anesthesia, and the tissue is examined immediately with frozen section histology. If cancer is confirmed, surgeons proceed to robot-assisted radical prostatectomy during the same anesthesia. If cancer is not confirmed or the result is unclear, the biopsy is extended and surgery is not performed. Researchers compare this approach with a retrospective group of 50 patients who had the conventional staged biopsy-then-surgery path.

What this could mean

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

Active substance
transperineal fusion-targeted prostate biopsy with intraoperative frozen section examination
What this could lead to
If the approach works, men with a high probability of prostate cancer could have diagnosis and surgery in one session, avoiding a separate biopsy procedure and the wait for results.
What could go wrong
This is a small pilot study with 10 participants, so the results may not apply broadly. Frozen section results can be unclear or wrong, and skipping a standard preoperative biopsy carries a risk that some cancers are missed or surgery is done unnecessarily.

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

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

18 years and older

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: 1. Serum prostate-specific antigen (PSA) level ≥20 ng/mL. 2. Findings suspicious for prostate cancer on digital rectal examination. 3. Multiparametric contrast-enhanced prostate MRI demonstrating a PI-RADS 4 or PI-RADS 5 lesion. 4. 68Ga-PSMA PET/CT demonstrating a prostate lesion with SUVmax ≥5.3 and no evidence of distant metastatic disease. 5. Written informed consent for participation in the study and for the protocol-defined diagnostic and surgical procedures, with subsequent management determined by the intraoperative frozen section result. Exclusion Criteria: 1. Previous prostate biopsy with histopathological confirmation of prostate cancer. 2. Evidence of distant metastatic disease on MRI and/or 68Ga-PSMA PET/CT. 3. Previous surgical or radiation treatment of the prostate that may affect the planned intervention or assessment of study outcomes. 4. Severe decompensated comorbidities or other contraindications to the protocol-defined surgical intervention or general anesthesia. 5. Contraindications to mandatory diagnostic procedures required by the study protocol. 6. Refusal to participate in the study or to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center

    Moscow, Moscow, 125284, Russia

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