Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT07172685

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

Led by Qilu Hospital of Shandong University · Updated on 2025-09-15

116

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 years or older
  • Histologically or cytologically confirmed prostate adenocarcinoma
  • Bone scan, CT, or MRI showing at least 4 bone metastases with at least 1 outside pelvis or spine, or visceral metastases
  • Newly diagnosed or recurrent disease sensitive to androgen deprivation therapy (ADT)
  • Received ADT for 3 months or less without evidence of soft tissue progression or significant PSA increase
  • Planned treatment including docetaxel plus apalutamide and ADT, or apalutamide plus ADT
  • ECOG performance status score of 0 or 1
  • Adequate bone marrow, liver, kidney, and coagulation function as specified
  • Use of effective contraception during the study and for 6 months after last dose
Not Eligible

You will not qualify if you...

  • Lesions at the prostate apex or inaccessible for focal therapy
  • Beaded prostatic calculi or cysts larger than 1 cm in treatment or ultrasound path
  • Urethral stricture or metal/other implants in the urethra
  • Prior rectal surgery or history of rectal fistula
  • Rectal stenosis preventing transrectal ultrasound
  • Rectal invasion
  • Active severe urinary tract infection
  • Severe cardiovascular or cerebrovascular disease affecting anesthesia or surgery
  • Hypersensitivity or intolerance to study drugs
  • Planned concurrent anticancer therapy
  • Prior treatment with second-generation androgen receptor inhibitors, CYP17 inhibitors, chemotherapy, immunotherapy, or adjuvant/neoadjuvant therapy
  • Use of herbal products with anti-prostate cancer or PSA-lowering effects within 4 weeks before treatment
  • History of seizures or conditions predisposing to seizures within 12 months
  • Active cardiac disease within 6 months before treatment
  • Conditions impairing drug absorption
  • Immunodeficiency or organ transplant history
  • Known brain metastases
  • Other malignancies within 5 years except certain cured cancers
  • Participation in another investigational drug/device trial
  • Poor compliance likely to hinder treatment or follow-up
  • Uncontrolled comorbidities compromising safety or study results
  • Any condition deemed unsuitable by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Qilu hospital

Jinan, Shandong, China, 276600

Actively Recruiting

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Research Team

S

Shouzhen Chen, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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