Focal Therapy in Localized Prostate Cancer: a Prospective Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorInstitut Mutualiste Montsouris
About this trial
The principal aim of the registry is to collect data on focal therapy (FT) for the treatment of intermediate-risk prostate cancer across Europe. Data will be gathered on cancer absence following treatment, survival rates, and the absence of disease failure or progression. Information will be collected from as many centers as possible over the next 5 years to enhance understanding of when focal therapy should be used, which energy types are most effective, and how patients respond to treatment, including its side effects and impact on quality of life.
This Europe-wide data collection will contribute to improving care by informing the development of enhanced national and international guidelines for prostate cancer treatment with focal therapy.
Eligibility criteria
Qualifiers
Patients with intermediate risk PCa based on EAU risk groups with life expectancy > 10 years
Prior targeted + systematic biopsy using US-MRI fusion technique
Primary focal treatment (targeted or partial gland ablation) of PCa lesion(s) detected on mpMRI, where PCa ISUP 2 or 3 has been identified. PCa ISUP 1 outside the treatment areas is acceptable, regardless of volume.
Focal treatment was performed using one of the following energies: high-intensity focused ultrasound (HIFU), cryotherapy (CRYO), brachytherapy (BT), irreversible electroporation (IRE), focal laser ablation (FLA), vascular-targeted Photodynamic (VTP) and radiofrequency ablation (RFA) according to the country rules, approvals, and regulations of each country in which they are applied. The registry cannot be used as a clinical trial or post-marketing surveillance study of the technologies applied.
Disqualifiers
Patients with intermediate risk treated with focal therapy without a previous targeted + systematic prostate biopsy with US-MRI fusion technique.
Primary focal treatment of PCa ISUP 2 or 3 in areas of prostate without evidence of lesions on MRI (MRI-invisible prostate cancer)
Patients with histological diagnosis of PCa with ISUP > 1 outside the areas of treatment
Primary whole gland treatments using ablative energy HIFU, cryotherapy, IRE, FLA, VTP and/or RFA
Trial design
Treatments tested in this trial
- Focal Therapy
Treatment groups
1,000 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Institut Mutualiste Montsouris
Lead sponsor
European Association of Urology Research Foundation
Collaborator
Source ClinicalTrials.gov