Focal therapy for men with prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of focal therapy as an alternative treatment for men with intermediate-risk prostate cancer, aiming to reduce the side effects associated with traditional radical treatments like prostatectomy and radiotherapy. Focal therapy selectively targets specific areas of the prostate while preserving the surrounding tissue, potentially improving patients' quality of life. The study will involve a multicenter randomized controlled trial with long-term follow-up and predefined assessments of cancer-specific and health-related quality of life outcomes. Economic evaluations will also be conducted to inform policymakers about the cost-effectiveness of this approach.

Why it matters

Who can join: the full rules

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

Where it's running

• Radboud University Medical Centre
  Nijmegen, Gelderland, Netherlands Recruiting
• Hifu kliniek
  Etten-Leur, North Brabant, Netherlands Not yet recruiting
• Amsterdam UMC
  Amsterdam, North Holland, Netherlands Not yet recruiting
• Isala klinieken
  Zwolle, Overijssel, Netherlands Not yet recruiting
• St. Antonius hospital
  Nieuwegein, Utrecht, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Lauren te Molder
• Email: Lauren.teMolder@radboudumc.nl
• Phone: +31243611111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.