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Can a tumor test predict aggressive prostate cancer in black men? new study aims to find out

NCT ID NCT02723734

Knowledge-focused Sponsor: H. Lee Moffitt Cancer Center and Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether the Decipher test, which predicts how aggressive prostate cancer is, works the same for African-American men as for other men. The test was developed mainly from samples of European men, but African-American men have higher rates of prostate cancer and death from it. Researchers will collect tumor samples from 240 men and see how well the test predicts cancer recurrence within two years. The goal is to help doctors choose the right treatment—avoiding unnecessary side effects for low-risk patients and giving more aggressive therapy to those who need it.

What this could mean

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

Active substance
Decipher test (genomic classifier test on tumor samples)
What this could lead to
If successful, this could help doctors better tailor prostate cancer treatment for African-American men, who face higher risks.
What could go wrong
This is an observational validation study, not a treatment trial. The test may not perform equally across groups, and results may not change outcomes directly.

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

240 people

The number who actually took part.

Started

Apr 2016

Expected to finish

Sep 2026

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

Men diagnosed with localized prostate cancer.

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: * Adult patients with Karnofsky Performance Status \>70 * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Pathologically (histologically) proven diagnosis of prostate cancer (PCa) undergoing their first line of treatment * Meet National Comprehensive Cancer Network (NCCN) criteria for either: Low risk PCa (defined as Gleason score 6 in ≥ 3 cores; T-stage T1c- T2a); Intermediate risk PCa (defined as Gleason score 7, or prostatic specific antigen (PSA) ≥ 10 ng/ml \& \< 20 ng/ml, or T-stage ≤ T2c) * Eligible for either radical prostatectomy (RP) or definitive radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) * Age \> 18 years * Biopsy specimen available Exclusion Criteria: * Inability to acquire biopsy or prostatectomy tissue * History of prior PCa directed chemotherapy or pelvic irradiation (prior to study enrollment) * Documented distant metastatic disease or pelvic lymphadenopathy * Prior radical prostatectomy (RP) or cryosurgery for prostate cancer or bilateral orchiectomy * Targeted for active surveillance after diagnostic biopsy * Selecting ADT alone after diagnostic biopsy * On active surveillance for \> 6 months after diagnosis

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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

  • Bay Pines VA Health care System

    Bay Pines, Florida, 33744, United States

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • James A. Haley VA Hospital

    Tampa, Florida, 33612, United States

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