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Can surgery boost survival in metastatic prostate cancer?

NCT ID NCT03456843

Disease control Sponsor: Yale 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study looks at whether surgically removing the prostate, along with hormone therapy and possibly chemotherapy, can help men whose prostate cancer has already spread. About 190 men with newly diagnosed stage IV prostate cancer will be randomly assigned to get either standard drug therapy alone or standard drug therapy plus surgery. The goal is to see if adding surgery delays cancer progression and improves quality of life.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2018

Expected to finish

Mar 2027

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

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: * Histologically proven adenocarcinoma of the prostate * Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation * Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis. * If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET \[positron emission tomography\], bone scan and MRI, modality at the discretion of the treating physician) * No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy, etc.) * Give informed consent * Prostate deemed resectable by surgeon * Plans to start or has already started ADT no longer than 6 months prior to consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Hemoglobin (HgB) \>= 9 g/dL compatible for surgery * Platelets \> 80,000/mcL compatible for surgery * Aspartate aminotransferase (AST) =\< 2x upper limit of normal (ULN) compatible for surgery * Alanine aminotransferase (ALT) =\< 2x upper limit of normal (ULN) compatible for surgery Exclusion Criteria: * Refuses to give informed consent * Deemed to have unresectable disease by surgeon * Received ADT for more than 6 months prior to consent * Life expectancy of less than 6 months prior to consent * Active spinal cord compression * Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent * Previous local therapy for prostate cancer * Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate adenocarcinoma

As listed by the trial registrant

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

Stage IV prostate adenocarcinoma ajcc V7

Contacts and locations

Locations

  • Akita University

    Akita, Japan

  • Chinese University of Hong Kong

    Hong Kong, China

  • City of Hope

    Duarte, California, 91010, United States

  • Epworth Healthcare

    East Melbourne, Australia, 9084, Australia

  • Juntendo University

    Tokyo, Japan

  • Kindai University

    Ōsaka-sayama, Osaka, 589-8511, Japan

  • National Cancer Center

    Goyang-si, South Korea

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903, United States

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Gyeonggi-do, South Korea

  • Swedish Medical Services

    Seattle, Washington, 98104, United States

  • University of California, Irvine

    Irvine, California, 92697, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • Yale University

    New Haven, Connecticut, 06519, United States

More trials for these conditions

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