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Study on Triple Therapy Combined With HIFU for High-Tumor-Burden mHSPC

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About this study

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.

Condition
Prostate Cancer
Tested
Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy
Sponsor
Qilu Hospital of Shandong University

Who can join

Age
18 years and older
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 23

  • Minimum age: 18 years
  • Eligible sex: Male
  • Study condition: Prostate Cancer
  • 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 significant PSA progression (≥50% increase from nadir with serum testosterone at castrate levels).
  • 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.

Exclusion 23

  • 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 adjuvant/neoadjuvant therapy.
  • 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.

Where

1 site, 1 recruiting

Qilu hospital

Jinan, Shandong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.