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Can a standardized Watch-and-Wait plan reduce prostate cancer overtreatment?

NCT ID NCT02914873

Disease control Sponsor: Uppsala University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a standardized active surveillance protocol to usual care for men with low-risk prostate cancer. The goal is to see if a clear set of rules for when to start treatment can reduce unnecessary treatments and side effects without raising the risk of cancer spread. About 2008 men will take part across multiple centers.

What this could mean

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

Active substance
active surveillance (monitoring with delayed treatment if needed)
What this could lead to
If successful, this could help many men with low-risk prostate cancer avoid unnecessary treatments and side effects while staying safe.
What could go wrong
This is a large but early-stage comparison study; the standardized protocol may not prove better than current practice, and some men might still face disease progression.

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

2,008 people

The number who actually took part.

Started

Oct 2016

Expected to finish

Dec 2034

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Recently (within 12 months) diagnosed adenocarcinoma of the prostate * Tumor stage less than or equal to T2a, NX, M0 * PSA less than 15 ng/ml, PSA density less than or equal to 0.20 ng/ml/cc * Gleason pattern 3+3=6 (any number of cores, any cancer involvement) * Gleason pattern 3+4=7 (less than 3 cores (or less than 30% of cores if more than 10 cores are taken), less than 10 mm cancer in one core) * Life expectancy more than 10 years with no upper age limit * Candidate for curative treatment if progression occurs * Signed written informed consent Exclusion Criteria: * none

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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

  • Akademiska University Hospital

    Uppsala, Sweden

  • Bedford Hospital

    Bedford, United Kingdom

  • Croydon University Hospital

    Croydon, United Kingdom

  • Epsom and St Helier Hospital

    London, United Kingdom

  • Guy's Hospital

    London, United Kingdom

  • Helsinki University Hospital

    Helsinki, Finland

  • Hospital of Vestfold

    Tønsberg, Norway

  • Linköping University Hospital

    Linköping, Sweden

  • Odense University Hospital

    Odense, Denmark

  • Oslo University Hospital

    Oslo, Norway

  • Queen Elisabeth Hospital

    London, United Kingdom

  • Rigshospitalet

    Copenhagen, Denmark

  • Royal Marsden Hospital

    London, United Kingdom

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

  • Seinäjoki Central Hospital

    Tampere, Finland

  • St Olavs University Hospital

    Trondheim, Norway

  • Sunderby Regional Hospital

    Luleå, Sweden

  • Sundsvall Regional Hospital

    Sundsvall, Sweden

  • Umeå University Hospital

    Umeå, Sweden

  • University Hospital of North Norway

    Tromsø, Norway

  • Växjö Hospital

    Vaxjo, Sweden

  • Ålesund Regional Hospital

    Ålesund, Norway

  • Örebro University Hospital

    Örebro, Sweden

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