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Prostate CancerPhase 2NCT07730151

Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer.

A Phase 2 study testing Darolutamide, docetaxel and ADT in people with Prostate Cancer and Prostate, run by RenJi Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this study is to evaluate the efficacy and safety of darolutamide combined with docetaxel and ADT compared to docetaxel combined with ADT in treating locally advanced prostate cancer patients scheduled for radical prostatectomy. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
What is being tested?
Darolutamide, docetaxel and ADT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 31 Dec 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male, age >= 18 years and <= 75 years at the time of signing the informed consent form;
  • Confirmed as prostate cancer by histological or cytological examination, and planned for radical prostatectomy;
  • 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);
  • Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1;
  • Expected lifespan >= 10 years;
  • 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;
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  • No difficulty in swallowing (can take the medicine in whole), chronic diarrhea, intestinal obstruction or other factors affecting drug administration and absorption;
  • No use of opioid analgesics (including codeine, oxycodone, etc.) to relieve cancer pain;
  • 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;
  • 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.

Who cannot join

  • Pathological diagnosis of neuroendocrine prostate cancer, including small cell carcinoma;
  • Prior local or systemic treatment for prostate cancer, including but not limited to radiotherapy, chemotherapy, or endocrine therapy;
  • Confirmed bone metastasis, hepatic metastasis, brain metastasis, or other visceral metastases on imaging;
  • Known hypersensitivity to the study drugs (active ingredients or excipients) or drugs of the same class;
  • Contraindications to prednisone acetate or docetaxel, such as active infection, allergy, or other conditions;
  • 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);
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  • Poorly controlled hypertension despite medication (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg);
  • Active or symptomatic viral hepatitis or other chronic liver disease; known human immunodeficiency virus (HIV) infection;
  • History of pituitary or adrenal dysfunction;
  • Active autoimmune disease requiring hormonal therapy;
  • 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;
  • History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Grade ≥2 peripheral sensory or motor neuropathy;
  • Other malignancies occurring within the past 2 years or currently concurrent malignancies;
  • Major surgery requiring general anesthesia within 28 days before the first dose;
  • 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;
  • History of epilepsy;
  • Alcohol or drug abuse or dependence;
  • Participation in another therapeutic clinical study within 1 month before the start of study treatment;
  • Any other condition that the investigator considers unsuitable for participation in this study;

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xiaoguang Shao contact

+(86)021-1234567

shaoxgg@163.com

About this study

Official title: Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer: A Multicenter, Prospective, Randomized Controlled Study

The goal of this study is to evaluate the efficacy and safety of darolutamide combined with docetaxel and ADT compared to docetaxel combined with ADT in treating locally advanced prostate cancer patients scheduled for radical prostatectomy. The participant population includes adult males with locally advanced prostate cancer (cT3b-cT4, N0, M0 or any cT, N1, M0). The main questions it aims to answer are:

Does the combination of darolutamide, docetaxel, and ADT improve treatment outcomes compared to docetaxel combined with ADT? What are the safety profiles and adverse effects associated with each treatment group? Researchers will compare the control group (docetaxel combined with ADT) to the experimental group (darolutamide combined with docetaxel and ADT) to see if the experimental treatment is more effective.

Read more

Participants will:

Receive either docetaxel combined with ADT or darolutamide combined with docetaxel and ADT for 4 cycles (16 weeks) as neoadjuvant treatment.

Undergo radical prostatectomy after completing the neoadjuvant treatment. Be followed up for 36 months post-surgery to assess treatment efficacy and safety.

Being tested
Darolutamide, docetaxel, ADT
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DarolutamideDrug

    Darolutamide: oral administration, 600 mg per dose, twice daily, taken with food.

  • docetaxelDrug

    Docetaxel: intravenous injection, 75 mg/m², once every 3 weeks, for a total of 4 doses/cycles. (Oral prednisone acetate should be started 14 days before docetaxel chemotherapy at 5 mg twice daily and discontinued 3 weeks after the last chemotherapy cycle.)

  • ADTDrug

    ADT: leuprorelin, goserelin, or triptorelin, selected by the investigator according to the patient's condition, administered by subcutaneous or intramuscular injection, using a once-monthly formulation uniformly.

Study groups in NCT07730151
Study groupRoleWhat they receive
Darolutamide + docetaxel + ADTExperimentalAdopting the triple neoadjuvant treatment regimen of Darolutamide + docetaxel + ADT
Receives: Drug: Darolutamide; Drug: docetaxel; Drug: ADT
Docetaxel + ADTActive comparatorAdopting the dual neoadjuvant treatment regimen of docetaxel + ADT
Receives: Drug: docetaxel; Drug: ADT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year biochemical progression-free survival (bPFS)

    Measured: Every 3 months (±14 days) up to 36 months after surgery

Secondary outcomes (13)

  1. Pathological Downstaging Rate after Radical Prostatectomy

    Measured: On Surgery day

  2. Incidence of Treatment-Related Adverse Events

    Measured: From screening visit to 30 days after the last neoadjuvant dose or start of new anticancer therapy

  3. Time to Castration-Resistant Prostate Cancer (CRPC) at 3 Years

    Measured: every 3 months PSA tests and every 6 months imaging assessments up to 36 months after surgery

  4. Objective Response Rate (ORR)

    Measured: 2-4 weeks after completion of neoadjuvant therapy

  5. 3-year Radiographic Progression-Free Survival (rPFS)

    Measured: Every 6 months (±1 month) post-surgery until 36 months post-surgery (months 6, 12, 18, 24, 30, 36)

  6. Undetectable PSA Rate post-Radical Prostatectomy

    Measured: 6 weeks post-surgery (±7 days)

  7. Subject Quality of Life as assessed by FACT-P( Functional Assessment of Cancer Therapy - Prostate) scale

    The FACT-P(Functional Assessment of Cancer Therapy - Prostate) scale will be used to assess the quality of life of subjects. The total score is calculated from the general functional and prostate cancer-specific subscale scores, with a total score range of 0 to 156, where higher scores indicate better functional status. Changes in the total score and individual domain scores will be analyzed.

    Measured: Baseline (V0), post-neoadjuvant/pre-surgery (V5), and at 6, 12, 24, 36 months post-surgery (±14 days)

  8. Perioperative Complications

    Measured: From surgery date through 90 days post-surgery

  9. Positive Surgical Margin Rate after Radical Prostatectomy

    Measured: On surgery day

  10. 3-year biochemical progression-free survival (bPFS)

    Measured: Every 3 months (±14 days) up to 36 months after surgery

  11. Time to Castration-Resistant Prostate Cancer (CRPC) at 3 Years

    Measured: PSA tests every 3 months and imaging assessments every 6 months up to 36 months post-surgery

  12. Pathological Complete Response (pCR) or Minimal Residual Disease (MRD) Rate

    Measured: On surgery day

  13. 3-year Overall Survival (OS)

    Measured: Every 3 months (+/-1 month) post-surgery until 36 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07730151
Sponsor's protocol ID
23233
Status last verified
Jul 2026
First submitted
7 Jul 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Darolutamide, docetaxel and ADT in people with Prostate Cancer and Prostate, run by RenJi Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaoguang Shao (+(86)021-1234567, shaoxgg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year biochemical progression-free survival (bPFS) (time frame: Every 3 months (±14 days) up to 36 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07730151.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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