C61
Conditions
Interventions
Group 1: Transurethral ultrasound ablation enables focal therapy of the tumor-carrying sector in localized prostate cancer in a single session. An applicator located in the urethra releases locally wa
Sponsors
Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie
Eligibility
Sex/Gender
Male
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: - locally limited unilateral, histologically confirmed prostate carcinoma - male patients aged > 65 years 6 weeks and < 4 months prior to the planned therapy and should be performed by MR-fused biopsy. - localized unilateral prostate carcinoma with visible lesion in baseline MRI. - maximum stage cT2a, Gleason 3+3=6 with maximum 4 affected cylinders or maximum stage cT2a with Gleason 3+4=7 with maximum 2 affected cylinders and maximum 50% of the punch cylinder surface affected. - initial PSA value <15 ng/ml - prostate volume < 90 ml - general anesthetic ability (ASA category <3) - MRI capability (see exclusion criteria) - ability to consent and written consent of the patient
Exclusion criteria
Exclusion criteria: - Bilateral infestation of the prostate gland - capsule transgression, sphincter infiltration, seminal vesicle infiltration, lymph node infestation, metastases - distance of tumor in baseline MRI more than 30 mm from urethra or within 3 mm around urethra, or in apex within 3 mm from sphincter - Previous transurethral resections of the prostate (TURP-P) or other prostate surgical procedures - Prostate calcifications (> 1 cm) within the sector to be treated (detected in TRUS, possibly in screening CT) - Cysts on the prostate capsule within the area to be treated (baseline MRI) - Clinically relevant prostatitis requiring treatment in the last 6 months prior to planned therapy - Previous operations of the rectum or pelvis - Chronic inflammatory bowel disease or other chronic diseases affecting the rectum, including fistulas and anal stenosis. - Z.n. Radiotherapy of the pelvis - Bladder or urethral dysfunction incl. urethralastricture, bladder diverticula, urethroplasty, fistulas etc. - Patients with an artificial bladder sphincter or penis implant - Severe neurogenic bladder dysfunction - Symptomatic prostate hyperplasia with significant residual urine formation - Untreated bladder stones - Acute urinary retention within the last 12 months - Acute untreated urinary tract infection - Active untreated macrohaematuria - Contraindications for MRT (cardiac pacemakers, defibrillators, non-mR-compatible endoprostheses, insulin pumps, grenade splinters, magnetic or electrically conductive implants, etc.) - Contraindications for the insertion of a suprapubic bladder catheter: pre-surgery in the pelvis, scars in the area of the lower abdomen, vascular Y-prostheses, etc. - Incompatibility/allergy to gadolinium (MRT contrast medium) - Participation of the patient in another clinical trial if this requires further experimental therapy or if the therapies/study protocols are mutually exclusive. - addiction or other illnesses which do not allow the person concerned to assess the nature and extent as well as possible consequences of the clinical trial - Absence of written declaration of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of patients with a complete remission histologically confirmed by a re-biopsy after 12 months a) in the treated area (at least 3 punches) and b) in the entire prostate (12 punches), as well as the frequency of all CTCAE 5.0 > grade 2 side effects within the first 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| - PSA-Nadir: Percentage of patients with a PSA decrease of 50% of baseline after 12 months - PSA progression: Proportion of patients without PSA increase by 30% over the nadir within 12 months - Urinary incontinence rate (EPIC item 5 > 1) - Obstruction Rate (IPSS) - Erectile dysfunction (IIEF 5) - Quality of life (EPIC-50) | — |
Countries
Germany
Contacts
Public ContactAnnett Klöber
Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum (E-Mail: str.studien@uniklinikum-dresden.de)
Outcome results
None listed