Prostate CancerHIFU NHT PCaNCT07126093
High-intensity Focused Ultrasound Combined With Novel Hormone Therapy in Advanced Prostate Cancer
A study testing focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapy and Standard novel hormonal therapy only in people with Prostate Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapy and Standard novel hormonal therapy only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
- Prostate biopsy pathology shows sarcomatoid cells, intraductal carcinoma, and neuroendocrine cell components;
- 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;
- 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;
- Concurrent infectious diseases that affect the treatment outcome.
About this study
Official title: An Exploratory Study on the Application of Focal High-intensity Focused Ultrasound (HIFU) Therapy Combined With Systemic Novel Hormone Therapy in Advanced Prostate Cancer
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.
Read the detailed description
An RCT study is conducted to include patients with advanced prostate cancer, who are randomly divided into two groups: the NHT alone group and the HIFU combined with NHT group. We compare the PFS after treatment to explore whether HIFU plus NHT improve the long-term survival and postpone progression. All patients will sign the informed consent form before enrollment and will be taken good care during study period. Patients will be screened according to the inclusion and exclusion criteria and will be given therapy according to randomization. Research data will be analyzed by a professional statistics team. The completion of the research will facilitate the expansion of HIFU into the comprehensive treatment of advanced PCa and will help improve the survival of such patients.
- Conditions
- Prostate Cancer
- Being tested
- focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapy, Standard novel hormonal therapy only
- Keywords
- prostate cancer, HIFU, NHT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapyCombination product
The participants in the intervention arm will receive HIFU combined with standard NHT. Depending on the location of the lesion, tumor load and the pathological conditions, hemicglandular ablation or focal ablation was selectively administered. The safe boundary was set at 3mm, with a power of 300W and a pulse width of 30ms. Novel endocrine therapy was given after HIFU treatment
Standard novel hormonal therapy onlyOther
Participants in the control arm will receive standard NHT.
| Study group | Role | What they receive |
|---|---|---|
| Combined group | Experimental | Participants in this arm will receive HIFU combined with standard NHT therapy Receives: Combination Product: focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapy |
| Standard treatment group | Other | Participants in this arm will receive standard NHT Receives: Other: Standard novel hormonal therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
PFS refers to the time from the start of randomization to disease progression. Disease progression includes biochemical progression, clinical progression and imaging progression. Biochemical progression is defined as a PSA increase of more than 25% and an absolute increase of 2ng/ml compared to the baseline/minimum value. The definition of clinical progression is the emergence of any new clinical symptoms related to the primary disease and metastases of prostate cancer. The definition of imaging progression in imaging is the appearance of any new metastatic lesions.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 80 months
Secondary outcomes (2)
overall survival (OS)
It refers to the time from the start of randomization to death for any reason
Measured: From date of randomization until the date of death from any cause, assessed up to 80 months
Time to castration resistance
Castration resistance is defined as : serum testosterone <50 ng/dL or 1.7 nmol/L plus any one of the following: ① Biochemical progression: Three consecutive increases in PSA (at least one week apart), with two increases of 50% compared to the lowest value, and the absolute value >2 ng/mL; ② Radiological progress: Two or more new bone metastases are found in imaging examinations such as bone scans, PET/CT, or one or more soft tissue lesions evaluated by the solid tumor response assessment criteria (RECIST 1.1 criteria, Appendix 1);
Measured: the time from the start of randomization to the occurrence of castration resistance, assessed up to 80 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Yu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126093
- Sponsor's protocol ID
- HIFUNHT20250808
- Acronym
- HIFU NHT PCa
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: While supporting data sharing principles, individual participant data (IPD) from this trial cannot be shared due to its proprietary nature and the need to protect individual information and intellectual property. Aggregate results will be published according to regulatory requirements and made available through standard reporting channels.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Application of Focal High-intensity Focused Ultrasound (HIFU) Therapy Combined With Systemic Novel Hormone Therapy in Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT07126093
- Acronym / sponsor ID
- HIFU NHT PCa / HIFUNHT20250808
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, HIFU, NHT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An RCT study is conducted to include patients with advanced prostate cancer, who are randomly divided into two groups: the NHT alone group and the HIFU combined with NHT group. We compare the PFS after treatment to explore whether HIFU plus NHT improve the long-term survival and postpone progression. All patients will sign the informed consent form before enrollment and will be taken good care during study period. Patients will be screened according to the inclusion and exclusion criteria and will be given therapy according to randomization. Research data will be analyzed by a professional statistics team. The completion of the research will facilitate the expansion of HIFU into the comprehensive treatment of advanced PCa and will help improve the survival of such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined group | Experimental | Combination Product: focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapyParticipants in this arm will receive HIFU combined with standard NHT therapy |
| Standard treatment group | Other | Other: Standard novel hormonal therapy onlyParticipants in this arm will receive standard NHT |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
- Prostate biopsy pathology shows sarcomatoid cells, intraductal carcinoma, and neuroendocrine cell components;
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapyThe participants in the intervention arm will receive HIFU combined with standard NHT. Depending on the location of the lesion, tumor load and the pathological conditions, hemicglandular ablation or focal ablation was selectively administered. The safe boundary was set at 3mm, with a power of 300W and a pulse width of 30ms. Novel endocrine therapy was given after HIFU treatment | Combination product | Combined group |
| Standard novel hormonal therapy onlyParticipants in the control arm will receive standard NHT. | Other | Standard treatment group |
Primary outcome
progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 80 months
PFS refers to the time from the start of randomization to disease progression. Disease progression includes biochemical progression, clinical progression and imaging progression. Biochemical progression is defined as a PSA increase of more than 25% and an absolute increase of 2ng/ml compared to the baseline/minimum value. The definition of clinical progression is the emergence of any new clinical symptoms related to the primary disease and metastases of prostate cancer. The definition of imaging progression in imaging is the appearance of any new metastatic lesions.
2 secondary outcomes
overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 80 months
Time to castration resistance
Time frame: the time from the start of randomization to the occurrence of castration resistance, assessed up to 80 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No. While supporting data sharing principles, individual participant data (IPD) from this trial cannot be shared due to its proprietary nature and the need to protect individual information and intellectual property. Aggregate results will be published according to regulatory requirements and made available through standard reporting channels.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapy and Standard novel hormonal therapy only in people with Prostate Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 80 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.