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Genetic prostate cancer screening study aims to catch tumors early

NCT ID NCT00261456

Knowledge-focused Sponsor: Institute of Cancer Research, United Kingdom 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

The IMPACT study is an international effort to screen men aged 40-69 who carry BRCA1, BRCA2, or mismatch repair gene mutations, which raise their risk of prostate cancer. Participants receive annual PSA tests and optional biopsies if levels are high. The goal is to learn how often prostate cancer is found in these men compared to those without the mutations, and to improve early detection strategies.

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 study could show that annual PSA screening helps detect prostate cancer earlier in men with certain gene mutations, potentially leading to better outcomes.
What could go wrong
This is an observational screening study, not a treatment trial. It may not prove that screening saves lives, and results may not apply to all men.

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

3,500 people

The number who actually took part.

Start date

Mar 2005

Expected to finish

Mar 2030

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

Any patient that meets the eligibility criteria and maybe attending a genetics clinic at a number of international centres that have gone through ethical approval.

Ages

40 to 69 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: * Male carriers of a known pathogenic BRCA1/2 or Mismatch Repair gene mutations (MSH2, MSH6, MLH1) or men testing negative for a known BRCA1/2/ Mismatch repair mutation (MSH2, MSH6, MLH1) in their family * Aged between 40-69 years old * WHO performance status 0-2 * No previous history of prostate cancer * No previous prostate biopsy for raised PSA * Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule * Fully informed, written consent according to ICH/EU GCP and national/local regulations before subject registration. Exclusion Criteria: * Previous cancer with terminal prognosis of less than 5 years * Previous prostate cancer

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Conditions

The condition(s) this trial relates to.

Colorectal Neoplasms, Hereditary Nonpolyposis inherited disease susceptibility prostate cancer

As listed by the trial registrant

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

BRCA mutation Genetic predisposition to disease Mismatch repair gene mutation Prostate cancer

Contacts and locations

Locations

  • Cancer Genetics Unit, Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT, United Kingdom

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