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New treatment option for Prostate Cancer
Official title Study on Triple Therapy Combined With HIFU for High-Tumor-Burden mHSPC
ClinicalTrials.gov ID: NCT07172685
What this study is testing
What is Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy?
Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single-arm prospective cohort study designed to evaluate the efficacy and safety of triple therapy (ADT + darolutamide + docetaxel) combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy in patients with high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC). A total of 116 high-tumor-burden mHSPC patients will be enrolled and are scheduled to receive the following treatment: Darolutamide + Docetaxel + ADT + Transrectal HIFU Focal Therapy for the Prostate.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Patients who agree to participate in the study and sign the informed consent form.
- Age ≥18 years, male.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Bone scan, CT, or MRI showing ≥4 bone metastases (with ≥1 outside the pelvis or spine) or visceral metastases.
- Newly diagnosed or recurrent disease after local therapy, with sensitivity to androgen deprivation therapy (ADT).
You likely can't join if
- Lesions located at the prostate apex or in areas inaccessible for focal therapy.
- Beaded prostatic calculi or cysts \>1 cm in diameter within the treatment or ultrasound pathway.
- Urethral stricture or presence of metal/other implants in the urethra.
- Prior rectal surgery.
- History of or existing rectal fistula.
- Rectal stenosis preventing transrectal ultrasound.
See the full eligibility criteria
- Patients who agree to participate in the study and sign the informed consent form.
- Age ≥18 years, male.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Bone scan, CT, or MRI showing ≥4 bone metastases (with ≥1 outside the pelvis or spine) or visceral metastases.
- Newly diagnosed or recurrent disease after local therapy, with sensitivity to androgen deprivation therapy (ADT).
- Patients who have received ADT (medical or surgical castration) with or without first-generation antiandrogens for ≤3 months, without evidence of soft tissue disease progression (per RECIST 1.1) or clinically...
- Planned treatment with docetaxel plus apalutamide and ADT, or apalutamide plus ADT.
- ECOG Performance Status (PS) score of 0-1.
- Adequate hematologic and organ function:
- \ \ Bone marrow function (without transfusion or growth factor support):\ \
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (1500/μL)
- Hemoglobin ≥90 g/L (9.0 g/dL)
- Platelet count ≥100 × 10⁹/L (100,000/μL)
- \ \ Liver function:\ \
- Total bilirubin (TBIL) ≤1.5 × ULN
- AST, ALT, and alkaline phosphatase (ALP) ≤2.5 × ULN
- \ \ Renal function:\ \
- Serum creatinine ≤1.5 × ULN \ \ or\ \ calculated creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
- \ \ Coagulation function (without anticoagulation therapy):\ \ INR ≤1.5
- Patients of reproductive potential must use effective contraception during the study and for 6 months after the last dose.
- Lesions located at the prostate apex or in areas inaccessible for focal therapy.
- Beaded prostatic calculi or cysts \>1 cm in diameter within the treatment or ultrasound pathway.
- Urethral stricture or presence of metal/other implants in the urethra.
- Prior rectal surgery.
- History of or existing rectal fistula.
- Rectal stenosis preventing transrectal ultrasound.
- Rectal invasion.
- Active severe urinary tract infection.
- Severe cardiovascular or cerebrovascular disease affecting anesthesia/surgery.
- History of hypersensitivity or intolerance to any study drugs.
- Planned concurrent anticancer therapy during the study.
- Prior treatment with second-generation androgen receptor (AR) inhibitors (e.g., apalutamide, enzalutamide, darolutamide), CYP17 inhibitors (e.g., abiraterone acetate, ketoconazole), chemotherapy, immunotherapy, or...
- Use of herbal products with anti-prostate cancer or PSA-lowering effects (e.g., saw palmetto) within 4 weeks before study treatment.
- History of seizures, medications that lower seizure threshold, or conditions predisposing to seizures within 12 months (including TIA, stroke, or traumatic brain injury with hospitalization).
- Active cardiac disease within 6 months before treatment: severe/unstable angina, myocardial infarction, congestive heart failure (NYHA Class III/IV), or arrhythmia requiring medication.
- Conditions impairing drug absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
- Immunodeficiency (e.g., HIV-positive, congenital/acquired immunodeficiency) or organ transplant history.
- Known brain metastases.
- Other malignancies within 5 years (except cured basal cell carcinoma or cervical carcinoma in situ).
- Concurrent participation in another investigational drug/device trial.
- Poor compliance likely to hinder treatment/follow-up.
- Uncontrolled comorbidities (e.g., hypertension, diabetes, neuropsychiatric disorders) that may compromise safety or confound results, per investigator judgment.
- Any other condition deemed unsuitable for inclusion by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.