Effectiveness of Focal Therapy in Men With Prostate Cancer
Recruiting · NCT06223295 · Interventional (participants receive a specific treatment) · Lead sponsor: Radboud University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 alternative to selectively treat a specific part of the prostate while preserving the rest of the gland. There is, however, a lack of high-quality evidence, and numerous papers therefore recommend to perform a multicenter randomized controlled trial (RCT). The RCT should have long-term follow-up, predefined assessment of cancer-specific and health-related QoL outcome measures, and economic evaluations to inform policymakers regarding cost-effectiveness. This RCT on focal therapy versus usual care is urgently needed to enable focal therapy to overgrow the experimental status, provide the evidence needed for guidelines, and make this available for selected patients who benefit from this strategy. Because of its promising results in other countries, focal therapy is increasingly requested by patients, but due to the lack of high-quality evidence, it is not reimbursed yet. This has been designated by both the PCa patient support group and physicians as a failure of both the market and the funding agencies. The investigators, therefore, aim to perform a high-quality multi-center RCT to provide the evidence needed to decide on reimbursement and implementation of focal therapy in patients with intermediate-risk, unilateral clinically localized PCa in the Netherlands.
Who can take part
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 is running
5 locations listed.
- Radboud University Medical Centre - Nijmegen, Gelderland, Netherlands
- Hifu kliniek - Etten-Leur, North Brabant, Netherlands
- Amsterdam UMC - Amsterdam, North Holland, Netherlands
- Isala klinieken - Zwolle, Overijssel, Netherlands
- St. Antonius hospital - Nieuwegein, Utrecht, Netherlands