Effectiveness of Focal Therapy in Men With Prostate Cancer

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Jan 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called focal therapy for men with prostate cancer. Unlike traditional treatments, which involve removing the entire prostate or using radiation, focal therapy targets only a specific area of the prostate. This method aims to reduce side effects such as urinary incontinence and erectile dysfunction while still effectively treating the cancer. Researchers believe that focal therapy could improve the quality of life for men with intermediate-risk prostate cancer and save significant healthcare costs.

To participate in this trial, men must meet certain criteria, such as having a specific type of prostate cancer with a Gleason score of 7 and a PSA level of 20 ng/ml or lower. They should also be generally healthy and expected to live at least 10 more years. Participants will receive either focal therapy or standard treatment, and the study will carefully track their health outcomes over time. This trial is important because it aims to gather the high-quality evidence needed to potentially make focal therapy a widely accepted treatment option that is covered by health insurance in the Netherlands.

Gender

MALE

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