Focal Therapy in Localized Prostate Cancer: a Prospective Registry (JR)

Institut Mutualiste Montsouris

Status: Not yet enrolling

Conditions: Prostate; Prostate Cancer

Treatments: Procedure: Focal Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT06772116

JUPITER2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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)

Trial design

1,000 participants in 1 patient group

Patients with intermediate-risk prostate cancer

Description:

he study includes patients with intermediate-risk prostate cancer (PCa), as defined by the European Association of Urology (EAU) risk groups, and a life expectancy of more than 10 years. Eligible patients must have undergone both targeted and systematic biopsies confirmed through the US-MRI fusion technique. All participants are required to provide informed, written consent before being included in the study.

Treatment:

Procedure: Focal Therapy