Focal Therapy in Localized Prostate Cancer: a Prospective Registry

Launched by INSTITUT MUTUALISTE MONTSOURIS · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how effective focal therapy (FT) is for treating intermediate-risk prostate cancer. Focal therapy is a targeted treatment that aims to destroy cancerous tissue while preserving as much healthy tissue as possible. The researchers will collect important information over the next five years from various medical centers across Europe. They want to find out how well this treatment works, how long patients live after treatment, and any side effects they may experience. The goal is to improve prostate cancer care by helping develop better guidelines for using focal therapy.

To be eligible for this study, patients must have intermediate-risk prostate cancer and a life expectancy of over 10 years. They should have undergone a specific type of biopsy to locate the cancer and will receive focal treatment for detected lesions. However, patients who have had previous prostate cancer treatments or have more advanced cases of cancer will not be included. Participants can expect to contribute to valuable research that may help improve future prostate cancer treatments while being monitored for their health outcomes and quality of life during and after the treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • Free, informed and written consent
• Exclusion Criteria:
• • 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
• • Primary subtotal/total treatments using ablative energy HIFU, cryotherapy, IRE, FLA, VTP and/or RFA
• • Life expectancy \<10 years
• • Previous treatment of PCa (excluded a period of Active Surveillance)
• • High risk PCa based on EAU risk groups.
• • Locally advanced PCa
• • Metastatic hormone-sensitive prostate cancer (mHSPC)
• • Metastatic castration-resistant prostate cancer (mCRPC)
• • Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)