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New scan could reveal hidden cancer in High-Risk prostate patients

NCT ID NCT07608419

Knowledge-focused Sponsor: General University Hospital, Prague 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study involves 400 men with high-risk prostate cancer who have not yet received treatment. Researchers are using a special type of scan called PSMA PET to see if it can find cancer that has spread to lymph nodes or other parts of the body, which standard scans often miss. The goal is to create a model that combines routine test results to predict who might have hidden cancer, helping doctors make better treatment decisions.

What this could mean

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

What this could lead to
If successful, this could help doctors better identify which high-risk prostate cancer patients have hidden cancer spread, leading to more personalized and effective treatment plans.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. The results may not apply to all patients or healthcare settings.

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.

Participants

About 400 people

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

Started

Jan 2016

Expected to finish

Dec 2027

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.

Who is studied

Persons: Male patients aged ≥ 18 years with histologically confirmed prostate adenocarcinoma. Place: The Czech Republic, including patients diagnosed and treated in Urological and ahiliated Nuclear Medicine Departments. Time period (Study Window): January 1, 2016 to December 31, 2025, capturing the transition toward molecular imaging in primary staging. Selection Criteria: Patients with histologically confirmed high-risk prostate cancer according to EAU guidelines who underwent primary staging with PSMA PET within the study window.

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 Male patients will be included if: * Male patients aged ≥ 18 years with histologically confirmed prostate adenocarcinoma, * high-risk disease defined as ISUP GG ≥ 4 and/or PSA ≥ 20 ng/ml and/or clinical stage assessed by DRE ≥ cT2c, * PSMA PET performed for primary staging within study window. Exclusion Criteria Patients with: * definitive local treatment (e.g., radical prostatectomy or radiation therapy) or systemic treatment (e.g., androgen deprivation therapy) administered prior to primary staging with PSMA PET, * low or intermediate-risk PCa as defined by failing to meet any of the inclusionary high-risk parameters, * incomplete or fragmented medical records that preclude the accurate extraction of primary staging parameters (PSA, ISUP GG, clinical T-stage) or PSMA PET results (miN/miM status), * active malignancy requiring systemic treatment at the time of PSMA PET.

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

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

High-risk prostate cancer Prostate cancer PSMA pet Staging

More trials for these conditions

Other studies related to the condition(s) this trial covers.