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
This trial does not accept healthy volunteersQualifiers
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 population
The study includes patients with intermediate-risk prostate cancer (PCa), as defined by the European Association of Urology (EAU) risk groups, with a life expectancy of more than 10 years. The criteria for intermediate-risk PCa are: PSA 10-20 ng/mL or GS 7 (ISUP grade 2/3) or cT2b (based on digital rectal examination). According to the latest EAU guidelines, patients with low-risk localized prostate cancer (PCa) should be offered active surveillance, while those with high-risk localized PCa should receive multimodal treatment. For intermediate-risk patients, alongside prostatectomy and radiotherapy, the EAU guidelines strongly recommend "focal ablative therapy within clinical trials or registries." The indication for treatment with focal therapy is entrusted to the clinicians of each center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Focal Therapy
Procedure/SurgeryPrimary focal treatment (targeted or partial gland ablation) of PCa lesion(s) detected on mpMRI, where a PCa ISUP 2 or 3 has been identified (PCa ISUP 1 outside the treatment areas is acceptable, regardless of volume). Focal treatment will be performed using one of the following energy-based techniques: high-intensity focused ultrasound (HIFU), cryotherapy (CRYO), brachytherapy (BT), irreversible electroporation (IRE), focal laser ablation (FLA), vascular-targeted photodynamic therapy (VTP), or radiofrequency ablation (RFA). The specific technique will depend on the rules, approvals, and regulations of the country where the treatment is performed.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Patients with intermediate-risk prostate cancer1 intervention
Trial outcomes
Primary outcomes
1
Rate of Negative Histological Findings for Prostate Cancer (PCa) on Target-Guided Biopsy of the Treated Area
The rate of negative histological findings for PCa (any ISUP grade) on target-guided biopsy of the treated area at 12 months post-FT (target or partial gland ablation) among patients who underwent biopsy (for any reason) among the cohort of 1,000 patients with intermediate-risk PCa enrolled.
Time frame
12 monthsSecondary outcomes
1
Overall Survival (OS)
Time from the date of focal therapy (FT) to the date of death from any cause.
Time frame
12-, 24-, 36-, 48- and 60-months after FT treatment2
Cancer-Specific Survival (CSS)
The time from the date of focal therapy (FT) to the date of death due to prostate cancer.
Time frame
12-, 24-, 36-, 48-, and 60-months after FT treatment3
Metastasis-Free Survival (MFS)
The time from the date of focal therapy (FT) to the date of the first imaging-confirmed distant metastasis.
Time frame
12-, 24-, 36-, 48-, and 60-months after FT treatment4
FT Impact on Erectile Function
Changes from baseline to 12 months after FT in erectile function, as measured by the Sexual Health Inventory for Men (SHIM). SHIM is a validated 5-item questionnaire with a total score ranging from 1 to 25, where higher scores indicate better erectile function. The questionnaire is included in the "Functional Assessment" (FA) and will be administered throughout the entire follow-up period.
Time frame
Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut Mutualiste Montsouris
Lead sponsor
European Association of Urology Research Foundation
Collaborator
Source ClinicalTrials.gov
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