HIFU for localized prostate cancer

High-Intensity focused ultrasound for localized prostate cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003781

Enrollment

Registered

2019-04-15

Start date

2019-03-18

Completion date

Unknown

Last updated

2019-04-23

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

Conditions

None listed

Interventions

Medical Device : &lt

Procedure&gt

Patients with localized prostate cancer who met the criteria for selection / exclusion were admitted on the day of the procedure, followed by general anesthesia Only one procedure is performed (estima

Uchida Grade&#39

, tissue monitoring 3. Postoperative - Discharge on the day of surgery - Removal of urethral catheter (1 week) - Bladder washing due to necrotic tissue occlusion and severe hematuria.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - age = 19 - localized prostate cancer (T1/T2, N0, M0) - T2a or T2b - Gleason score = 7 - Prostate specific antigen (PSA) = 15

Exclusion criteria

Exclusion criteria: - If transrectal ultrasonography is not possible. - rectum - if you have an active disease of the anus - If you have undergone pseudoradicular prostate surgery within 2 months - If you have a history of cryotherapy, radiation therapy, hormone therapy, etc. - If anesthesia is not appropriate - If MRI can not be performed with an artificial pacemaker or artificial joint - If there is severe calcification (> 1 cm) that can not be done with focused ultrasound treatment (except when the calcification is removed by performing pseudo-prosthetic surgery before 2 months of focused ultrasound) - For a large prostate larger than 50 cc (if the size of the prostate is reduced by performing pseudo-prostate surgery before 2 months of focused ultrasound) - Latex allergy

Design outcomes

Primary

Measure	Time frame
radiologic recurrence of prostate cancer after HIFU	—

Secondary

Measure	Time frame
Biochemical recurrence of prostate cancer after HIFU;voiding symptom (International Prostate Symptom Score; IPSS);erectile function (International index of erectile function; IIEF);other complications	—

Countries

Korea, Republic of

Contacts

Public ContactKyu Won Lee

The Catholic University of Korea, Seoul St. Mary's Hospital

firss@hanmail.net+82-2-2258-6366

Outcome results