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A prospective, completely randomized controlled clinical study of H-FIRE combined with endocrine therapy and endocrine therapy alone for prostate cancer

A prospective, completely randomized controlled clinical study of H-FIRE combined with endocrine therapy and endocrine therapy alone for prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089502
Enrollment
Unknown
Registered
2024-09-10
Start date
2023-07-10
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

High frequency irreversible electroporation combined with endocrine therapy:High frequency irreversible electroporation combined with endocrine therapy
Endocrine therapy alone:Endocrine therapy alone

Sponsors

Shanghai East Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Fully understand the treatment plan for irreversible electroporation and sign informed consent; 2. The patient is diagnosed with metastatic prostate cancer and intends to undergo endocrine therapy; 3. Age range of 40-90 years old.

Exclusion criteria

Exclusion criteria: 1. Patients with severe arrhythmia, who are assessed by the anesthesiology department to have contraindications for anesthesia or high-risk intraoperative placement of cardiac pacemakers; 2. Patients with implanted cardiac pacemakers; 3. Other tumors of the urinary system, such as bladder cancer, kidney cancer, and ureteral cancer;Patients with malignant tumors in other parts of the body, for whom researchers cannot assess their long-term survival or whether it is affected;or patients in acute infection period or other severe infection (including active hepatitis B or C virus infection, urinary system infection);Patients with HIV-positive; 4. Patients with a history of epilepsy; 5. Patients with other serious systemic diseases that the researchers believe may interfere with the treatment, evaluation and compliance of this trial; 6. Patients who have participated in other clinical trials within three months; 7. ASA classification of 4 or above, such as patients with malignant hypertension, recent myocardial infarction, active stage of cerebrovascular accident, severe anemia, and other contraindications to elective surgery under general anesthesia; 8. Patients who are judged by the researchers to be unfit for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
PSA progression free survival period;Whole machine stability assessment;

Secondary

MeasureTime frame
Median survival period;Disease progression time;Time-to-Treatment Failure;Adverse event;Combination medication;

Countries

China

Contacts

Public ContactHaifeng Wang

Shanghai East Hospital

446720864@qq.com+86 136 8175 0891

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026