Can a Triple-Drug cocktail before surgery curb prostate Cancer's return?
NCT ID NCT07730151
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
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.
- Ages
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18 to 75 years
- 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: 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.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
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- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?