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New prostate cancer drug tested in small chinese study

NCT ID NCT06136598

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase study tested a new drug called MK-5684 (opevesostat) in 14 Chinese men with a type of advanced prostate cancer that no longer responds to standard hormone therapy. The main goals were to check the drug's safety and how the body processes it. Participants took the drug as tablets, along with other medications to manage side effects.

What this could mean

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

Active substance
Opevesostat (MK-5684) tablets, taken with dexamethasone, fludrocortisone, and possibly hydrocortisone
What this could lead to
If successful, this could point toward a new treatment option for men with advanced prostate cancer that has stopped responding to hormone therapy.
What could go wrong
This is a very early, small Phase 1 study with only 14 participants, focused on safety and drug levels, not effectiveness. The drug may not work or could have side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

Jan 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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.

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology. * Has prostate cancer while receiving androgen deprivation therapy (ADT), or post-bilateral orchiectomy, within 6 months before screening. * Has evidence of progression \>4 weeks since last flutamide treatment or \>6 weeks since last bicalutamide or nilutamide treatment. * Has evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue shown by CT/MRI. * Has disease that progressed during or after treatment with at least 1 line of next-generation hormonal agents (NHAs) for hormone-sensitive prostate cancer (HSPC) or castration-resistant prostate cancer (CRPC) for at least 8 weeks (at least 14 weeks for participants with bone progression). * Has received at least 1 line of taxane-based chemotherapy for HSPC or CRPC and have had progressed disease during or on treatment, or refused or ineligible to receive chemotherapy. * Has a life expectancy of \>3 months. Exclusion Criteria: * Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years. * Has presence of gastrointestinal condition, e.g. malabsorption, that might affect the adsorption of study intervention. * Has a history of pituitary dysfunction. * Has poorly controlled diabetes mellitus. * Has active or unstable cardio/cerebro-vascular disease, including thromboembolic events. * Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 4 weeks of the date of allocation. * Has received an anticancer monoclonal antibody (mAb) within 4 weeks of allocation, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of allocation. * Received prior systemic anticancer therapy including investigational agents within 4 weeks before the date of allocation. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any form of immunosuppressive therapy within 7 days prior to the start of study intervention. * Has a known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has an active autoimmune disease that has required systemic treatment in the past 2 years. * Has a history of or current human immunodeficiency virus (HIV) infection. * Has a concurrent Hepatitis B or Hepatitis C virus infection. * Has a history of allogenic tissue or solid organ transplant.

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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.

Contacts and locations

Locations

  • Peking University First Hospital-Urology ( Site 0001)

    Beijing, Beijing Municipality, 100034, China

  • Sun Yat-sen University Cancer Center-Neurosurgery department ( Site 0003)

    Guangzhou, Guangdong, 510700, China

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 0002)

    Wuhan, Hubei, 430000, China

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