Back to Search Results- Recruiting
- Treatment
- Interventional
- Randomized
- Procedure
- Radboud University Medical Center
- 45 Years -
Study Purpose
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.
Intervention
Procedure : Focal therapy
Procedure : Usual care
Eligibility Requirements
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
Minimum age: 45
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
Recruiting status
Recruiting
Estimated enrollment
356
Study start date
Feb 01, 2024
Study end date
Feb 28, 2031
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Procedure
Study phase
NA
Allocation
Randomized
Sponsor:
Radboud University Medical Center
Collaborator:
Isala
Amsterdam UMC, location VUmc
St. Antionius Hospital
Hifu kliniek
Dutch National Health Care Institute
ZonMw: The Netherlands Organisation for Health Research and Development
Nederlandse Vereniging voor Radiotherapie en Oncologie
Wetenschapscommissie interventieradiologie/Nederlandse vereniging voor interventieradiologie
Inspire2live
Prostaatkankerstichting
Nederlandse Vereniging voor Urologie
Investigator:
N/A
N/A
Publications
Websites
N/A
NCT06223295
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