NCT07126093Not yet recruiting
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 · Last updated 17 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 8 Aug 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Prostate cancer
- NCT number
- NCT07126093
What you commit to
- Study type: Interventional
- Planned participants: 134
- From 1 Oct 2025 to the primary completion date, 31 Oct 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent infectious diseases that affect the treatment outcome.
Other illness
- 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);
- Accompanied by severe comorbidities, immunosuppression, severe mental illness, severe activity limitation and other conditions that prevent compliance with clinical trials;
- Currently participating in other clinical trials related to this disease;
Other
- Prostate biopsy pathology shows sarcomatoid cells, intraductal carcinoma, and neuroendocrine cell components;
- 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;
Who the study is looking for
- Male patients who are at least 18 years old;
- The physical condition score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 to 2 points.
- Newly diagnosed patients with advanced prostate cancer confirmed by PSMA PET/CT (including metastatic hormone-sensitive prostate cancer or inoperable locally advanced prostate cancer);
- No previous treatments for prostate cancer have been received;
- After assessment, there was no obvious insufficiency of vital organs.
- 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.
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.