NCT07172685 Study on Triple Therapy Combined With HIFU for High-Tumor-Burden mHSPC

Trial Parameters

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Brief 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 Criteria

Inclusion Criteria: 1. Patients who agree to participate in the study and sign the informed consent form. 2. Age ≥18 years, male. 3. Histologically or cytologically confirmed prostate adenocarcinoma. 4. Bone scan, CT, or MRI showing ≥4 bone metastases (with ≥1 outside the pelvis or spine) or visceral metastases. 5. Newly diagnosed or recurrent disease after local therapy, with sensitivity to androgen deprivation therapy (ADT). 6. 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). 7. Planned treatment with docetaxel plus apalutamide and ADT, or apalutamide plus ADT. 8. ECOG Performance Status (PS) score of 0-1. 9. Adequate hematologic and organ function: * \*\*Bone marrow function (without transfusion or growth factor support):\*\* *

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