MRI-guided transurethral ultrasound ablation in patients with localized prostate cancer

Not Applicable

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00017242
• Lead Sponsor: niversitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-09
• Study Completion: 2021-10-01
• Results First Posted: 2023-06-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

locally limited unilateral, histologically confirmed prostate carcinoma
- male patients aged > 65 years < 80 years
- patients in good general condition (ECOG 0-1)
- histologically confirmed adenocarcinoma of the prostate (targeted MR-fused biopsy combined with systematic biopsy). Histologic confirmation should be > 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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- PSA-Nadir: Percentage of patients with a PSA decrease of 50% of baseline after 12 months <br>- PSA progression: Proportion of patients without PSA increase by 30% over the nadir within 12 months<br>- Urinary incontinence rate (EPIC item 5 > 1)<br>- Obstruction Rate (IPSS)<br>- Erectile dysfunction (IIEF 5)<br>- Quality of life (EPIC-50)