High intensity focused ultrasound (HIFU) and Eligard in patients with high risk prostate cancer
- Conditions
- prostate cancerC61Malignant neoplasm of prostate
- Registration Number
- DRKS00005179
- Lead Sponsor
- niversitätsklinikum Magdeburg A.ö.R.Dekan der Medizinische FakultätProf. Dr. Hermann-Josef-Rothkötter
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 60
• Prostate cancer, classification by D´Amico High Risk”, meaning PSA > 20 ng/mL and/or
Gleason-Score = 8 and/or
cT-Kategorie = 2c
• Clinical tumor stadium cT1c to cT3
• Life expectancy of at least 10 years
• Patients for whom radical prostatectomy is not an option or who re-fuse this procedure
• Patients for whom radiotherapy is not an option or who refuse this procedure.
• Normal anatomy of rectum and rectal wall
• ASA classification of 1, 2 or 3 with good general health and life expectancy of at least 10 years
• Karnofsky index = 80%
• Patient must be mentally competent and able to complete the various questionnaires on symptoms and quality of life in their entirety
• Patient must be willing to leave the choice between the two therapies to chance
• Intention and possibility to attend all necessary follow-up appoint-ments and submit to all necessary study procedures
• Voluntary consent to study participation after complete disclosure of the nature and purpose of the study, confirmed by signature on the consent document.
• Neuroendocrine classification of prostate cancer
• Clinical T4 tumor in rectal area (digital examination)
• Previous radical treatment of prostate cancer
• Previous hormone therapy for prostate cancer
• Seed implants (brachytherapy)
• Shadow-producing calcification in the prostate that can significantly disturb treatment (inclusion possible after TURP)
• Pre-existing urethral strictures or bladder neck spasm (the patient may be included after treatment has been carried out)
• Pre-existing urinary infections or prostatitis (the patient may be in-cluded after the infection has been treated)
• Reduced kidney function (creatinine > 160 mmol/L)
• Rectal fistula
• Patients with intraprostatic implants, such as stents or catheters, or any type of prosthesis or implant with the exception of a suprapubic catheter for urinary diversion
• Thermotherapy or hyperthermia treatment within the past 3 months
• Patients interested in retaining their fertility
• Patients who have participated in other clinical or pharmacological studies in the past 30 days
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemical recurrence free survival (Phoenix-criteria; Nadir + 2 ng/ml)<br><br>Time Frames:<br><br>Visit 1 - Start of trial participation<br><br>Visit 2 - six months after the start of the study<br><br>Visits 6 - 8: 30, 36, 42 months after study entry<br><br>Visit 9 (at Progress or 48 months after baseline)<br><br>- All visits: control laboratory values ??(PSA, testosterone), upper urinary tract and bladder ultrasonography, transrectal ultrasound
- Secondary Outcome Measures
Name Time Method • Overall survival <br>• Biopsy evidence of local recurrence<br>• Need for an additional or different cancer therapy<br>• Need for TURP (consideration of size, symptoms and echogenicity of the prostate)<br>• Morbidity of therapy (acute and follow-on complications)<br>• Quality of life during therapy: IIEF-5 score, SPSS score, QLQ-C30 score, QLQ-PR 25, RTOG-criteria (immediate and later rectal side effects)<br><br>Time Frames:<br><br>Visit 1 - Start of trial participation<br><br>Visit 2 - six months after the start of the study<br><br>Visits 6 - 8: 30, 36, 42 months after study entry<br><br>Visit 9 (at Progress or 48 months after baseline)<br><br>- At each visit assessment of quality of life sheets, as well as control laboratory values ??(PSA, testosterone), upper urinary tract and bladder ultrasonography, transrectal ultrasound