Clinical trial · Interventional
Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
Feasibility Study for Locally Recurrent Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
NCT00318240CI-TRIAL-00029285completedN/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 is a feasibility study to determine safety and the ability of HIFU (High Intensity Focused Ultrasound)to selectively destroy prostate cancer tissue in men who demonstrate local recurrence of prostate cancer following radiation treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Intensity Focused Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- High Intensity Focused
- interventionNames
- Device: High Intensity Focused Ultrasound
Primary outcomes (1)
- measure
- To determine the efficacy of HIFU in men with local recurrent prostate cancer following radiation therapy.
- timeFrame
- ongoing
Secondary outcomes (2)
- measure
- Destruction of prostate cancer tissue.
- timeFrame
- ongoing
- measure
- Safety of repeating procedure in patients who do not respond adequately.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * · Male patients with an initial presentation of organ confined recurrent prostate cancer (clinical Stages T1 and T2 only) who have been treated with external beam radiation therapy or brachytherapy and subsequently has biopsy-proven local recurrence. * Age \> 40 years through \<80 years. * Anesthesia Surgical Assignment (ASA) categories I, II or III only. * Negative radionuclide bone scan within 3 months prior to HIFU treatment to rule out the possibility of metastases. * PSA levels \>0.5ng/ml and \<10ng/ml. * Pre-radiation Gleason score \< 8 * Clearly imageable prostate on TRUS * Written informed consent. Exclusion Criteria: * · T3 or T4 prostate cancer. * Age \<40 years. or \>80 years. * ASA of IV and higher. * Gleason score\>8. * PSA \<0.5ng/ml or \>10ng/ml. * Prostate size \> 40 grams as determined by transrectal ultrasound * Large calcification in the area to be treated (\>5mm). * Bleeding disorder as determined by abnormal prothrombin time (INR)and partial thromboplastin time (PTT). * Patient on Coumadin or any other anticoagulant, unless their anticoagulation can be temporarily reversed or stopped. * Urinary tract infection unless treated satisfactorily by antibiotics and documented by a sterile urine culture. * Interest in future fertility. * History of allergy to latex. * Inability to visualize the prostatic tissue adequately on transrectal ultrasound imaging. * Currently on hormonal therapy for prostate cancer (patients can be enrolled if they come off hormone therapy for 3 months). * History of treatment for prostate cancer, other than brachytherapy or external beam radiation. * History of TURP, thermotherapy or urethral stent. * History of any major rectal surgery. * History of inflammatory bowel disease. * History of urinary bladder neck contracture. * History of any other malignancy other than skin cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.