Skip to content

Extracorporeal Focused Ultrasound Surgery for Prostate Cancer: a Feasibility and Safety Study

Extracorporeal Focused Ultrasound Surgery for Prostate Cancer: a Feasibility and Safety Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028710
Enrollment
Unknown
Registered
2020-01-01
Start date
2019-12-31
Completion date
Unknown
Last updated
2020-01-06

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

Conditions

Prostate cancer

Interventions

Case series:Focused ultrasound ablation

Sponsors

National Engineering Research Center for Ultrasound Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed low-risk / medium-risk prostate cancer: (1) Gleason score 6 - 7 points (3 + 3, 3 + 4 or 4 + 3); (2) PSA=3 points; 3. Life expectancy is >=10 years. 4. There are indications for radical prostatectomy (RP) for patients with prostate cancer and they are willing and have chosen to receive RP; 5. Safe acoustic path and focus can reach the target area; 6. Target area can be detected by real-time ultrasound.

Exclusion criteria

Exclusion criteria: 1. Prior treatments: endocrine therapy (androgen deprivation therapy (ADT), a reductase inhibitors and / or other hormonal therapy), prostate surgery (transurethral resection of the prostate within 6 months/), radiotherapy / local radioactive particle implantation, other local prostate treatments (including radiofrequency ablation and cryotherapy); 2. Rectal diseases; 3. There are calcifications in the prostate that can affect the energy deposition or safety of ultrasound; 4. Bladder or lower urinary tract stones; 5. Active urinary tract infection; 6. Metal implants / stent in the urethra; 7. Patients cannot keep lithotomy position; 8. Patients with strong requirements of keeping sexual function / fertility; 9. Patients with other malignancies; 10. Contraindications to MRI scans; 11. Cannot understand or refuse to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Coagulative necrosis;

Secondary

MeasureTime frame
prostate specific antigen, PSA;Changes in target blood flow perfusion;

Countries

China

Contacts

Public ContactYong Liang

Zigong Fourth People's Hospital

liangyong6619@126.com+86 13909006619

Outcome results

None listed

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