Clinical trial · Interventional
High-intensity Focused Ultrasound Combined With Novel Hormone Therapy in Advanced Prostate Cancer
An Exploratory Study on the Application of Focal High-intensity Focused Ultrasound (HIFU) Therapy Combined With Systemic Novel Hormone Therapy in Advanced Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to explore the feasibility and the synergistic anti-cancer effect of high-intensity focused ultrasound (HIFU) combined with novel hormone therapy (NHT) in advanced prostate cancer (PCa). The main questions it aims to answer are: (1) whether could HIFU combined with NHT improve the long-term survival of patients with advanced PCa and alleviate local symptoms? (2) Does the synergistic effect of HIFU combined with NHT exist? Researchers will compare HIFU combined with NHT to NHT alone in advanced PCa patients. Participants will receive HIFU before NHT therapy or only receive NHT. In addition, participants are encouraged to record local symptoms condition and conduct regular follow-up.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapy | Combination Product | — | UNRESOLVED |
| Standard novel hormonal therapy only | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combined group
- description
- Participants in this arm will receive HIFU combined with standard NHT therapy
- interventionNames
- Combination Product: focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapy
- type
- OTHER
- label
- Standard treatment group
- description
- Participants in this arm will receive standard NHT
- interventionNames
- Other: Standard novel hormonal therapy only
Primary outcomes (1)
- measure
- progression-free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male patients who are at least 18 years old; 2. The physical condition score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 to 2 points. 3. Newly diagnosed patients with advanced prostate cancer confirmed by PSMA PET/CT (including metastatic hormone-sensitive prostate cancer or inoperable locally advanced prostate cancer); 4. No previous treatments for prostate cancer have been received; 5. After assessment, there was no obvious insufficiency of vital organs. 6. Sign the written informed consent form for this study, indicating that they fully understand the purpose and process of this study and are willing to participate in it. Exclusion Criteria: 1. A history of any other active malignant tumor within 2 years (excluding well-treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other carcinoma in situ currently in complete remission); 2. Prostate biopsy pathology shows sarcomatoid cells, intraductal carcinoma, and neuroendocrine cell components; 3. Accompanied by severe comorbidities, immunosuppression, severe mental illness, severe activity limitation and other conditions that prevent compliance with clinical trials; 4. Currently participating in other clinical trials related to this disease; 5. According to the researcher's judgment, there are relevant evaluations that do not align with the best interests of the subjects' participation in the study (such as affecting the subjects' sense of happiness) or may hinder, restrict or interfere with the research protocol; 6. Concurrent infectious diseases that affect the treatment outcome.
References
Publications (0)
Data not yet available