Clinical trial · Interventional
Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer
A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU
NCT00770822CI-TRIAL-00038051SetPaceunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Device | — | UNRESOLVED |
| HIFU (Sonablate® 500) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Device, HIFU
- description
- High Intensity Focused Ultrasound
- interventionNames
- Device: HIFU (Sonablate® 500)
- type
- ACTIVE_COMPARATOR
- label
- Device, brachytherapy
- description
- Brachytherapy
- interventionNames
- Device: Brachytherapy
Primary outcomes (1)
- measure
- The primary endpoint will be the absence of biochemical failure, which is defined as a rise of 2.0 ng/mL or more above the PSA nadir and negative biopsy at 24 months.
- timeFrame
- 24 Months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * T1c or T2a carcinoma of the prostate confirmed by biopsy; * life expectancy of 5(five) years or more; * prostate biopsy with 10(ten) or more core biopsies; * Gleason score of 6(six) or less; * serum Prostate Specific Antigen (PSA) of 10(ten)ng/ml or less; * prostate volume of less than 40(Forty)cc; * distance from the Anterior capsule surface to the Posterior capsule surface (AP Diameter) of 40(Forty)cm or less; * informed consent for the treatment study through 24 months post-treatment follow-up Exclusion Criteria: * men who have had previous definitive treatment for prostate cancer; * evidence of metastatic disease and/or a previous positive bone-scan, previous diagnosis or treatment for cancer within the last 5(five) years; * prior hormonal therapy for prostate cancer (including bilateral orchiectomy); * inability to tolerate a transrectal ultrasound; * active urinary tract infection; * functional bladder problems; * prior significant rectal surgery; * intra-prostatic calcifications greater than 1(One)cm in diameter; * interest in future fertility; * prostatic surgery/procedure (except biopsy) within 1(One) year; * large median lobe of the prostate; * use of medications that can affect PSA within 2(Two) months (e.g. finasteride, saw palmetto); * current bladder cancer, urethral stricture, or bladder neck contracture; * urinary tract and/or rectal fistula; * rectal fibrosis/stenosis; * anomaly of the rectal anatomy or mucus membrane; * prostate seroma/abcess; * prostatitis; * compromised renal function or upper urinary tract disease secondary to urinary obstruction; * bleeding disorders/coagulopathy based on measures of PT and PTT; * implant in the prostate or within 1(One)cm of the prostate; * zip code of the primary residence of the subject is greater than 200(Two hundred) miles from the clinical site or transportation that would hinder the completion of the study
References
Publications (0)
Data not yet available
No reference posted for this study.