Focal therapy for men with prostate cancer

Effectiveness of Focal Therapy in Men With Prostate Cancer

This study is testing a new treatment called focal therapy for men with intermediate-risk prostate cancer to see if it can reduce side effects and improve their quality of life compared to traditional treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 356 (estimated)
• Ages: 45 Years and up
• Sex: Male
• Sponsor: Radboud University Medical Center (other)
• Locations: 5 sites (Nijmegen, Gelderland and 4 other locations)
• Trial ID: NCT06223295 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men with intermediate-risk prostate cancer, specifically those with a Gleason score of 7 and a PSA level of ≤ 20 ng/ml.

Not a fit: Patients with low-risk or high-risk prostate cancer, or those who have previously received treatment for prostate cancer, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce treatment-related complications and improve the quality of life for men with prostate cancer.

How similar studies have performed: Previous studies have suggested the potential benefits of focal therapy, but this approach is still considered novel and requires further high-quality evidence.

Eligibility criteria

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 this trial is running

Nijmegen, Gelderland and 4 other locations

• 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

Conditions: Prostate Cancer, Prostate Neoplasm, prostate neoplasm, focal therapy, prostate cancer