prostate cancer C61
Conditions
Interventions
Group 1: HIFU (ABLATHERM®) + two years ELIGARD 45mg
A 6-month depot Eligard ® 45 mg administered to patient by injection.
Group 2: two years ELIGARD 45mg
A 6-month depot Eligard ® 45 mg administere
Sponsors
Universitätsklinikum Magdeburg A.ö.R.
Dekan der Medizinische Fakultät
Prof. Dr. Hermann-Josef-Rothkötter
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical recurrence free survival (Phoenix-criteria; Nadir + 2 ng/ml) Time Frames: Visit 1 - Start of trial participation Visit 2 - six months after the start of the study Visits 6 - 8: 30, 36, 42 months after study entry Visit 9 (at Progress or 48 months after baseline) - All visits: control laboratory values ??(PSA, testosterone), upper urinary tract and bladder ultrasonography, transrectal ultrasound | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall survival • Biopsy evidence of local recurrence • Need for an additional or different cancer therapy • Need for TURP (consideration of size, symptoms and echogenicity of the prostate) • Morbidity of therapy (acute and follow-on complications) • Quality of life during therapy: IIEF-5 score, SPSS score, QLQ-C30 score, QLQ-PR 25, RTOG-criteria (immediate and later rectal side effects) Time Frames: Visit 1 - Start of trial participation Visit 2 - six months after the start of the study Visits 6 - 8: 30, 36, 42 months after study entry Visit 9 (at Progress or 48 months after baseline) - 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 | — |
Countries
Germany
Contacts
Public ContactMartin Schostak
Universitätsklinikum Magdeburg A.ö.R. Klinik für Urologie und Kinderurologie
Outcome results
None listed