Exploratory Study on the Efficacy and Safety of Triple Therapy (ADT + Darolutamide + Docetaxel Chemotherapy) Combined With Transrectal High-Intensity Focused Ultrasound Focal Therapy in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) With High Tumor Burden

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Qilu hospital
RECRUITING
Jinan
Contact Information
Primary
Shouzhen Chen, Dr.
chensz@mail.sdu.edu.cn
18560089085
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 116
Treatments
Experimental: Experimental Arm
The study plans to enroll 116 patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) who will receive the following treatment regimen: Darolutamide , Docetaxel , ADT and transrectal high-intensity focused ultrasound (HIFU) focal therapy for the prostate. Patients will receive each drug according to the prescribing information, with dose adjustments based on adverse reactions (as per the prescribing guidelines).
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov