Can we tell which prostate cancers are dangerous? new study aims to find out.
NCT ID NCT00756665
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This study follows 3,000 men with early-stage prostate cancer who have chosen active surveillance (close monitoring instead of immediate treatment). The goal is to discover biological markers that can tell apart aggressive cancers from slow-growing ones. Researchers hope this will help men avoid unnecessary treatments while catching dangerous cancers early.
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
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About 3,000 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Jul 2008
- Expected to finish
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Sep 2032
An estimate. End dates often move.
- Lead sponsor
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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
Urology Clinic
- Ages
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21 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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: * Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy. * Clinically localized prostate cancer: T1-2, NX or N0, MX or M0. * No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy). * ECOG Performance Status 0 or 1. * Patient has elected Active Surveillance as preferred management plan for prostate cancer. * Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens. * Patient is accessible and compliant for follow-up. * Prostate cancer diagnosis cannot be more than 3 years prior to baseline visit date. * No more than two prostate biopsies including the initial biopsy in which cancer was diagnosed. * If cancer diagnosis is more than one year before enrollment, there must be two prostate biopsies including the initial biopsy in which cancer was diagnosed and a subsequent biopsy. The subsequent biopsy may occur on the same day as the baseline visit. * Biopsies must have at least 10 cores. Exclusion Criteria: * Unwillingness or inability to undergo serial prostate biopsy. * History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for \> 5 years.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center/Harvard Medical School
RECRUITINGBoston, Massachusetts, 02215, United States
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Eastern Virginia Medical School
RECRUITINGNorfolk, Virginia, 23502, United States
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Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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Stanford University
RECRUITINGStanford, California, 94305, United States
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University of British Columbia
RECRUITINGVancouver, British Columbia, V5Z 1M9, Canada
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University of California, San Francisco
RECRUITINGSan Francisco, California, 94143, United States
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48105, United States
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University of Texas Health Science Center, San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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University of Washington
RECRUITINGSeattle, Washington, 98195, United States
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Veterans Affairs Puget Sound Health Care System
RECRUITINGSeattle, Washington, 98108, United States
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Veterans Affairs San Francisco Health Care System
RECRUITINGSan Francisco, California, 94121, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Radiation boost may extend Drug-Free time in prostate cancer recurrence
- Can a smart drug deliver a toxic payload to prostate cancer cells?
- Can AI outthink cancer experts? a landmark trial pits five AIs against tumor boards
- Hormone therapy showdown: can an oral pill beat the shot for prostate cancer patients?