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New hope for advanced prostate cancer: drug cocktails enter human trials

NCT ID NCT07230106

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase II study tests two experimental drugs, HS-20093 and SHR2554, combined with standard hormone therapies in 218 men with metastatic prostate cancer. The goal is to see if these combos are safe and can lower PSA levels or slow the cancer's spread. Participants must have adenocarcinoma and be in good overall health.

What this could mean

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

Active substance
HS-20093, SHR2554, abiraterone, enzalutamide, darotamine
What this could lead to
If successful, this could lead to new combination treatments that better control metastatic prostate cancer and delay disease progression.
What could go wrong
This is an early phase II trial with a small number of participants, so results may not apply to all patients. The combinations may cause side effects or fail to improve outcomes.

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 218 people

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

Started

Dec 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

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 to 80 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: 1. Voluntarily participate in this clinical study, understand the research procedures, and are able to provide written informed consent. 2. Aged 18 to 80 years (inclusive), male. 3. ECOG performance status of 0 or 1. 4. Expected survival time ≥12 weeks. 5. Histologically or cytologically confirmed prostate adenocarcinoma, with no features of neuroendocrine carcinoma or small cell carcinoma. 6. Able to provide sufficient tumor tissue samples for retrospective genetic testing. 7. Ongoing Androgen Deprivation Therapy (ADT) throughout the study period, i.e., continuous treatment with a GnRH agonist or antagonist (chemical castration) or prior bilateral orchiectomy (surgical castration). 8. PSA level ≥1 ng/ml at screening. 9. Adequate organ function levels at baseline assessment. 10. Male participants with female partners of childbearing potential must agree to refrain from sperm donation and use effective contraception from the time of signing the informed consent form until 4.5 months after the last dose of HS-20093 or 3 months after the last dose of other study treatments, whichever is later. Exclusion Criteria: 1. Known hypersensitivity or intolerance to the investigational drug(s) or their excipients. 2. Adverse events from prior anti-tumor therapy have not recovered to Grade ≤1 as per CTCAE v5.0. 3. Administration of estrogen, progesterone, or 5-alpha reductase inhibitors within 28 days prior to enrollment. 4. Administration of herbal medicines known to have anti-prostate cancer or PSA-lowering effects within 14 days prior to enrollment. 5. Major surgery within 28 days prior to enrollment; palliative radiotherapy within 14 days prior to enrollment; or traumatic minor surgery within 7 days prior to enrollment. 6. Pathological fractures in critical locations, spinal cord compression, etc., within the recent 6 months. 7. Non-healing wounds, untreated fractures, or severe bone damage due to metastatic disease. 8. Poorly controlled tumor-related pain. 9. Dysphagia or other conditions significantly affecting drug absorption. 10. Known central nervous system metastases or primary brain tumors. 11. Significant pericardial, pleural, or peritoneal effusion requiring intervention. 12. Severe cardiovascular or cerebrovascular diseases. 13. Moderate to severe pulmonary disease significantly affecting respiratory function. 14. Poorly controlled diabetes. 15. Serious active infections within 14 days prior to enrollment. 16. Active Hepatitis B, Hepatitis C, HIV, or immunodeficiency diseases. 17. History of other malignancies within 5 years prior to enrollment. 18. Any other condition deemed by the investigator to potentially affect the study.

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

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