Focal Therapy in Localized Prostate Cancer: a Prospective Registry

Not yet recruiting

• Conditions: Prostate; Prostate Cancer

• Registration Number: NCT06772116
• Lead Sponsor: Institut Mutualiste Montsouris

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-27
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-02
• Primary Completion: 2028-02
• Study Completion: 2032-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 1000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Negative Histological Findings for Prostate Cancer (PCa) on Target-Guided Biopsy of the Treated Area	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	12-, 24-, 36-, 48- and 60-months after FT treatment	Time from the date of focal therapy (FT) to the date of death from any cause.
Cancer-Specific Survival (CSS)	12-, 24-, 36-, 48-, and 60-months after FT treatment	The time from the date of focal therapy (FT) to the date of death due to prostate cancer.
Metastasis-Free Survival (MFS)	12-, 24-, 36-, 48-, and 60-months after FT treatment	The time from the date of focal therapy (FT) to the date of the first imaging-confirmed distant metastasis.
FT Impact on Erectile Function	Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)	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.
FT Impact on Lower Urinary Tract Symptoms	Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)	Changes from baseline to 12 months after FT in urinary symptoms, as measured by the International Prostate Symptoms Score (IPSS). IPSS is a validated 7-item questionnaire with a total score ranging from 0 to 35, where higher scores indicate more severe urinary symptoms.; The questionnaire is included in the "Functional Assessment" (FA) and will be administered throughout the entire follow-up period.
FT impact on Ejaculatory Function	Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)	Changes from baseline to 12 months after FT in ejaculatory function, as measured by the 1st and 4th items of the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form (MSHQ-EjD SF). Scores for the 1st item range from 0 to 5, with higher scores indicating better ejaculatory function. Scores for the 4th item range from 0 to 5, with higher scores indicating greater bother related to ejaculatory dysfunction as perceived by the patient.; The questionnaire is in included in the "Functional Assessment" (FA) and will be used during the whole follow-up.
FT impact on Quality of Life	Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)	Changes from baseline to 12 months after FT in quality of life related to prostate cancer, as measured by the Overall Prostate Cancer QoL Score of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP). Scores range from 0 to 100, with higher scores indicating worse quality of life.; The questionnaire is in included in the "Functional Assessment" (FA) and will be used during the whole follow-up.
Complications	at 3, 6, 9, and 12 months, and then annually until 60 months after treatment.	Complications related to the FT treatments will be recorded using a text-free module that includes the option to select specific types of common complications (e.g., untreated bacteriuria, urinary tract infection (UTI) treated with antibiotics, acute urinary retention, bleeding, pain not relieved by common painkillers, or severe hematoma). In all cases, the Clavien-Dindo classification will be applied to categorize any post-operative complications recorded.
Prostate Failure-Free Survival (pFFS)	12-, 24-, 36-, 48- and 60-months after FT treatment	Time from the date of focal therapy until the occurrence of an ISUP 2 PCa or higher in the treated area and/or untreated area found during the follow up.; The success of FT is evaluated based on the absence of clinically significant prostate cancer throughout the entire prostate (prostate-based approach). The presence of clinically significant prostate cancer in either the untreated and/or treated areas will be considered a failure.
Area Treated Failure-Free Survival (aFFS)	12-, 24-, 36-, 48- and 60-months after FT treatment	"Time from the date of focal therapy until the occurrence of an ISUP 2 PCa or higher in the treated area, as identified during follow-up. The success of FT is evaluated based solely on the treated area (area-treated-based approach), and only the presence of clinically significant prostate cancer within the treated area will be considered a failure.
Progression free survival (PFS)	12-, 24-, 36-, 48- and 60-months after FT treatment	Will be calculated using the time from the date of focal therapy (FT) to the date progression is reported. Progression is defined as the requirement for whole-gland treatments, including salvage radical prostatectomy, salvage external beam radiotherapy, salvage brachytherapy, salvage whole gland ablation, and systemic therapy (androgen deprivation therapy, chemotherapy, anti-androgens, PARP inhibitors, AKT inhibitors, immune checkpoint inhibitors, and radiopharmaceutical therapy).
Salvage Treatments Rate	12-, 24-, 36-, 48- and 60-months after FT treatment	The rate of salvage treatments, including Active Surveillance, Watchful Waiting strategy, Salvage Radical Prostatectomy, Salvage External Beam Radiotherapy, Salvage Brachytherapy, Salvage Whole Gland Ablation, and Systemic Therapies (e.g., androgen deprivation therapy, chemotherapy, anti-androgens, PARP inhibitors, AKT inhibitors, immune checkpoint inhibitors, and radiopharmaceutical therapy), will be recorded for each patient.
Rate of complications associated with Salvage Treatments	at 3, 6, 9, and 12 months, and then annually until 60 months after treatment.	Complications associated with Salvage Treatments will be recorded using a text-free module that includes the option to select specific types of common complications (e.g., untreated bacteriuria, urinary tract infection (UTI) treated with antibiotics, acute urinary retention, bleeding, pain not relieved by common painkillers, or severe hematoma). In all cases, the Clavien-Dindo classification will be applied to categorize any post-operative complications recorded.