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Prospective Real-World Study of Transrectal High-Intensity Focused Ultrasound (HIFU) for the Treatment of Localized Prostate Cancer

Prospective Real-World Study of Transrectal High-Intensity Focused Ultrasound (HIFU) for the Treatment of Localized Prostate Cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105917
Enrollment
Unknown
Registered
2025-07-14
Start date
2025-03-14
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Prostate Cancer

Interventions

Single-Arm HIFU Treatment Group:NA

Sponsors

Cancer Hospital Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. Pathologically confirmed localized prostate cancer (stage T1a-T2cN0M0) by biopsy; 3. No prior history of radical radiotherapy or radical prostatectomy for prostate cancer; 4. Gleason score <= 8; 5. Voluntary participation with signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Lesions located at the apex of the prostate, or lesions that cannot be reached by the focal point, or acoustic pathways obstructed by calcifications, urethral stents, etc. 2. Presence of obvious cystic cavities within the prostate (diameter > 10 mm). 3. Concurrent bladder cancer or active urinary tract infection. 4. Urethral stricture or functional bladder disease. 5. Severe cardiovascular and cerebrovascular diseases affecting anesthesia and surgery. 6. Previous rectal surgery affecting treatment. 7. Inability to undergo transrectal ultrasound. 8. Other conditions deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Failure-Free Survival, FFS;

Secondary

MeasureTime frame
Disease-free survival,DFS;The minimum value and duration of PSA;

Countries

China

Contacts

Public ContactNianzeng Xing

Cancer Hospital Chinese Academy of Medical Sciences

xingnianzeng@126.com+86 10 87787170

Outcome results

None listed

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