Trial document




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  DRKS00017242

Trial Description

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Title

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

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Trial Acronym

FOKATU-Pilot

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this pilot study is to evaluate the feasibility, safety and efficacy of MRI-guided transurethral ultrasound ablation for the treatment of focal tumor lesions in early localized prostate cancer with curative intent.

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Brief Summary in Scientific Language

Various therapeutic strategies can be considered for early localized prostate cancer. Radical surgery and primary radiotherapy (percutaneous or as LDR brachytherapy) are established therapeutic options, but involve the risk of chronic life-threatening side effects such as urinary incontinence, erectile dysfunction, proctitis and obstructive symptoms.
New, often still clinically-experimental, therapeutic approaches are therefore directed towards focal therapies for locally limited prostate carcinoma in order to avoid such side effects. Focal therapy is based on the consideration that a lesion limited to a prostate lateral lobe does not require therapy of the entire prostate, but only in the affected area in order to reduce side effects to a minimum.

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Organizational Data

  •   DRKS00017242
  •   2019/05/09
  •   [---]*
  •   yes
  •   Approved
  •   EK392102018, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   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 warming (57°C) ultrasound energy in selected areas of the prostate (sectors) due to MRI thermometry control.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

- 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)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2019/06/01
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   65   Years
  •   80   Years
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Additional 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

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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

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Addresses

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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Mr.  Dr. med.  Tobias  Hölscher 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Mr.  Dr. med.  Tobias  Hölscher 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum (E-Mail: str.studien@uniklinikum-dresden.de)
    • Ms.  Annett  Klöber 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.