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MRI Guided Transurethral HIFU for Various Prostate Diseases

NCT03350529 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2024-11-25

No results posted yet for this study

Summary

This study assesses feasibility and safety, the primary outcomes, of MRI guided transurethral high intensity focused ultrasound (HIFU) ablation for prostate diseases (PD). We will enrol 10 patients to each group with criteria as follows: localised prostate cancer (PC); locally advanced PC; locally recurrent PC after external beam radiation therapy (EBRT); benign prostatic hyperplasia (BPH). Secondary outcomes are both oncologic and functional outcomes and imaging based follow up after HIFU therapy will be also assessed.

Conditions

  • Localised Prostate Cancer
  • Locally Advanced Prostate Cancer
  • Locally Recurrent Prostate Cancer
  • Benign Prostatic Hyperplasia

Interventions

DEVICE

MRI guided transurethral HIFU ablation of prostatic tissue

The technology is developed to ablate targeted benign and malignant prostate tissue through transurethrally inserted probe that transmit ultrasound energy under MRI guidance and control. The therapeutic endpoint of this method is thermal coagulation of prostate tissue.

Sponsors & Collaborators

  • University of Turku

    collaborator OTHER

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Peter Boström, M.D.Ph.D · Department of Urology, VSSHP, University of Turku

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-24
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350529 on ClinicalTrials.gov