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Effectiveness of Focal Therapy in Men With Prostate Cancer

RecruitingNAAges 45 Years - anyMaleRadboud University Medical Center
NCT06223295 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In the Netherlands, most men with prostate cancer (PCa) are treated with radical whole-gland treatment, i.e. prostatectomy or radiotherapy. The burden of complications such as incontinence and erectile dysfunction associated with radical treatment is considerable. A recent systematic review by our group has shown that focal therapy of PCa seems to reduce the burden of treatment side-effects in men with intermediate-risk disease, maintaining their quality of life without compromising oncological effectiveness. The costs of side effects that can be prevented are estimated at €5456 per patient, resulting in total expected cost savings of about €22 million per year in The Netherlands. Furthermore, exploration of the benefit-risk balance under patients showed that they are willing to sacrifice some survival for an improvement in quality of life (QoL). Focal therapy comprises a modern alterna

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📋 Eligibility rules (as published)
Inclusion Criteria: * Gleason score of 7 (3 + 4 or 4 + 3; ISUP grade 2/3) * PSA level of ≤ 20 ng/ml * Clinical stage ≤ T2b disease * Life expectancy of ≥ 10 years * Men with a prostate size ≤ 5 cm in sagittal length and ≤ 6 cm in axial length * Fit, eligible, and normally destined for radical surgery or radiotherapy * No concomitant cancer * No previous treatment of their prostate * An understanding of the Dutch language sufficient to receive written and verbal information about the trial, its consent process and the study questionnaires Exclusion Criteria: * Unfit for general anesthesia or radical surgery * Low volume low-risk disease (≤4mm Gleason score of ≤ 6 / ISUP grade 1) * High-risk disease (Gleason score of ≥ 8 / ISUP grade \>3) * Clinical T3 disease (extracapsular PCa) * Men who have received previous active therapy for PCa. * Men with evidence of extraprostatic disease. * Men with an inability to tolerate a transrectal ultrasound. * Cardiac pacemaker * Metal implants/stents in the urethra or prostate. * ASA ≥4 * Prostatic calcification/cysts that interfere with effective delivery of TULSA/HIFU based on MRCT. * Men with renal impairment and a glomerular filtration rate (GFR) of \< 30 ml/minute/1.73 m2. * Unable to give consent to participate in the trial, as judged by the attending clinicians
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What it tests

  • Focal therapy
  • Usual care
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Where

5 sites
Radboud University Medical Centre
Nijmegen, Netherlands
Hifu kliniek
Etten-Leur, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
Isala klinieken
Zwolle, Netherlands
St. Antonius hospital
Nieuwegein, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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