NCT06772116

Focal Therapy in Localized Prostate Cancer: a Prospective Registry

Jupiter Registry: Prospective Registry for Patients Undergoing Focal Therapy for Localized Prostate Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Institut Mutualiste Montsouris · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Focal Therapy has been introduced and evaluated as a minimally invasive treatment aimed at improving management strategies for localized prostate cancer. This technique consists of ablating the dominant lesion while preserving as much of the non-cancerous tissue as possible, and treating only the areas that require intervention. The aim of the Jupiter Registry is to establish a registry for patients with intermediate-risk prostate cancer undergoing FT. The registry will prospectively gather standardized data from multiple European centers. The goal is to collect data from as many centers as possible over a 5-year follow-up period to inform clinical practices on FT indications, energy type selection, and patient outcomes, including efficacy, complications, and quality of life. This Europe-wide, reliable data will help develop national and international recommendations and guidelines to improve patient care. This registry will subsequently enable the development of Jupiter Studies, a series of registry-based studies designed to analyze specific research questions regarding focal therapy in patients with intermediate-risk prostate cancer. The aim is to generate robust evidence on various aspects (efficacy, safety, functional impact, oncological impact) of focal therapy in a real-world evidence context. Data such as PSA levels, MRI results, and biopsy outcomes will be collected during patient follow-up. Additionally, data on salvage treatments will be documented, including the type and complications of any salvage treatments performed during follow-up up to 60 months post-FT. Although the registry provides a uniform data collection on the population of patients with intermediate-risk localized prostate cancer who have undergone FT in accordance with EMA recommendations (Guideline on registry-based studies EMA/426390/2021), the principal and secondary aims defined below will subsequently enable the realization of the Jupiter Studies.

Conditions

• Prostate
• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Focal Therapy	Primary 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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2028-02-01
• Completion: 2032-02-01
• First posted: 2025-01-13
• Last updated: 2025-01-13