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Can a Triple-Drug cocktail before surgery curb prostate Cancer's return?

NCT ID NCT07730151

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests whether adding darolutamide to standard chemotherapy and hormone therapy before prostate removal can improve long-term outcomes for men with locally advanced prostate cancer. Participants receive either the triple combination or the standard two-drug regimen for 16 weeks before surgery, then are followed for three years. The study aims to see if the extra drug delays cancer recurrence and reduces the chance of the cancer becoming resistant to treatment.

What this could mean

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

Active substance
darolutamide, docetaxel, and ADT (androgen deprivation therapy)
What this could lead to
If successful, this combination could become a standard pre-surgery treatment to reduce cancer recurrence in locally advanced prostate cancer.
What could go wrong
This is a Phase 2 trial with a moderate sample size, so results may not be definitive. Adding darolutamide could increase side effects like fatigue, hot flashes, or liver issues.

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 200 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

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 to 75 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. Male, age \>= 18 years and \<= 75 years at the time of signing the informed consent form; 2. Confirmed as prostate cancer by histological or cytological examination, and planned for radical prostatectomy; 3. Clinical stage conforms to the definition of locally advanced prostate cancer: cT3b-cT4, N0, M0 or any cT, N1, M0 (based on PSMA-PET/CT examination); 4. Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1; 5. Expected lifespan \>= 10 years; 6. Important laboratory indicators meet the following requirements: a. Hemoglobin \>= 90 g/L b. Serum total bilirubin \<= 1.5 times the upper limit of normal value, transaminase (AST/ALT) \<= 2.5 times the upper limit of normal value c. Serum albumin \>= 30 g/L d. Serum creatinine \<= 1.5 times the upper limit of normal value e. Absolute neutrophil count \>= 1.5 x 10\^9/L, platelet count \>= 100 x 10\^9/L; 7. No difficulty in swallowing (can take the medicine in whole), chronic diarrhea, intestinal obstruction or other factors affecting drug administration and absorption; 8. No use of opioid analgesics (including codeine, oxycodone, etc.) to relieve cancer pain; 9. If the spouse is a fertile female, the subject consents to take effective contraceptive measures during the treatment period and for 4 months after the surgery; 10. The subject voluntarily participates in this trial, signs the informed consent form, and is willing to comply with the requirements of the research protocol throughout the study period. Exclusion Criteria: 1. Pathological diagnosis of neuroendocrine prostate cancer, including small cell carcinoma; 2. Prior local or systemic treatment for prostate cancer, including but not limited to radiotherapy, chemotherapy, or endocrine therapy; 3. Confirmed bone metastasis, hepatic metastasis, brain metastasis, or other visceral metastases on imaging; 4. Known hypersensitivity to the study drugs (active ingredients or excipients) or drugs of the same class; 5. Contraindications to prednisone acetate or docetaxel, such as active infection, allergy, or other conditions; 6. Chronic disease requiring prednisone acetate at doses exceeding those specified in the protocol (5 mg orally twice daily, starting 14 days before docetaxel chemotherapy and stopping 3 weeks after the last chemotherapy cycle); 7. Poorly controlled hypertension despite medication (systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=95 mmHg); 8. Active or symptomatic viral hepatitis or other chronic liver disease; known human immunodeficiency virus (HIV) infection; 9. History of pituitary or adrenal dysfunction; 10. Active autoimmune disease requiring hormonal therapy; 11. Major cardiovascular or cerebrovascular disease within 6 months prior to the start of study treatment, including: severe/unstable angina, myocardial infarction, congestive heart failure \[New York Heart Association (NYHA) class III or above\], cerebrovascular accident, or arrhythmia requiring pharmacological treatment; 12. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 13. Grade ≥2 peripheral sensory or motor neuropathy; 14. Other malignancies occurring within the past 2 years or currently concurrent malignancies; 15. Major surgery requiring general anesthesia within 28 days before the first dose; 16. Treatment with strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ketoconazole) or strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, phenobarbital, St. John's wort) that cannot be discontinued, and have not been stopped for at least 7 days before randomization; 17. History of epilepsy; 18. Alcohol or drug abuse or dependence; 19. Participation in another therapeutic clinical study within 1 month before the start of study treatment; 20. Any other condition that the investigator considers unsuitable for participation in this 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 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 ↗

  2. A doctor treating you

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More trials for these conditions

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