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New study aims to predict hidden aggressive prostate cancer

NCT ID NCT02189486

Knowledge-focused Sponsor: The University of Texas Health Science Center at San Antonio 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study gathered information and samples from 382 men with low-grade prostate cancer to create a tool that can better predict if the cancer is actually more aggressive than it appears. The goal is to help doctors and patients make more informed decisions about treatment. Participants had their prostate removed, and researchers compared the initial biopsy results with the final tissue analysis.

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

382 people

The number who actually took part.

Start date

Aug 2014

Finished

Jun 2025

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

We will recruit a cohort of 600 men with prostate cancer who have elected radical prostatectomy for treatment of their prostate cancer within two years after prostate biopsy. This biopsy must show no greater grade than Gleason 3+3 disease as determined on central pathology review. The patient may have had previous biopsies that showed cancer but may never have had a tumor grade greater than Gleason 3+3.

Ages

35 to 99 years

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. Prostate cancer, confirmed on prostate biopsy, within two years of scheduled radical prostatectomy. 2. Prostate cancer must be graded as Gleason 3+3 on the biopsy immediately prior to radical prostatectomy. (Secondary eligibility will be established on central review of pathology slides, and blocks if available, at Cornell Central Pathology Laboratory to confirm eligibility.) 3. Prostate cancer may have been detected on prior biopsy as well but must not be greater than Gleason 3+3. (Also requires Central Pathology Laboratory review.) 4. Slides must be available for Central Pathology Laboratory review on any biopsy showing prostate cancer. FFPE Blocks may also be requested if available. 5. Patient must have selected radical prostatectomy as treatment for prostate cancer. 6. Signed informed consent. 7. Blocks and/or slides from prostate biopsy and from radical prostatectomy must be available for analysis by Central Pathology laboratory. 8. Willingness to provide long-term follow-up information regarding additional treatments and cancer status. 9. Willingness to provide blood and urine specimens prior to radical prostatectomy for placement in the EDRN Upgrading Reference Set repository. 10. Willingness to provide demographic and clinical information related to prostate cancer and prostate cancer risk (e.g., race/ethnicity, family history of prostate cancer). Exclusion Criteria: 1. Gleason score greater than 3+3 on any prior prostate biopsy. 2. Any treatment other than radical prostatectomy planned for prostate cancer. 3. Prior treatment of the prostate with androgen deprivation, radiation, or other cytotoxic chemotherapy.

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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

Contacts and locations

Locations

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

More trials for these conditions

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