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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer; Prostate
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Giuseppe Maiolino, MD; Phone Number: +39 3204066478; Email: jupiter.registry@gmail.com
• Study Contact Backup: Name: Andrea Rodríguez Serrano, MD; Phone Number: +34 609 10 60 08; Email: andrearodriguezserrano@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with intermediate-risk prostate cancer; 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.

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.; Other Names: Targeted Therapy for Prostate Cancer; Partial Gland Ablation (PGA); Energy-Based Ablative Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time from the date of focal therapy (FT) to the date of death from any cause.	12-, 24-, 36-, 48- and 60-months after FT treatment
Cancer-Specific Survival (CSS)	The time from the date of focal therapy (FT) to the date of death due to prostate cancer.	12-, 24-, 36-, 48-, and 60-months after FT treatment
Metastasis-Free Survival (MFS)	The time from the date of focal therapy (FT) to the date of the first imaging-confirmed distant metastasis.	12-, 24-, 36-, 48-, and 60-months after FT treatment
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.	Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
FT Impact on Lower Urinary Tract Symptoms	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.	Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
FT impact on Ejaculatory Function	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.	Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
FT impact on Quality of Life	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.	Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
Complications	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.	at 3, 6, 9, and 12 months, and then annually until 60 months after treatment.
Prostate Failure-Free Survival (pFFS)	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.	12-, 24-, 36-, 48- and 60-months after FT treatment
Area Treated Failure-Free Survival (aFFS)	"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.	12-, 24-, 36-, 48- and 60-months after FT treatment
Progression free survival (PFS)	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).	12-, 24-, 36-, 48- and 60-months after FT treatment
Salvage Treatments Rate	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.	12-, 24-, 36-, 48- and 60-months after FT treatment
Rate of complications associated with Salvage Treatments	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.	at 3, 6, 9, and 12 months, and then annually until 60 months after treatment.

Collaborators and Investigators

• Sponsor: Institut Mutualiste Montsouris
• Collaborators: European Association of Urology Research Foundation
• Investigators: Principal Investigator: Eric Barret, MD, PhD, Institut Mutualiste Montsouris; Principal Investigator: Juan I Martinéz-Salamanca, MD, PhD, Lyx Institute of Urology

Publications and helpful links

General Publications

• Hopstaken JS, Bomers JGR, Sedelaar MJP, Valerio M, Futterer JJ, Rovers MM. An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years? Eur Urol. 2022 Jan;81(1):5-33. doi: 10.1016/j.eururo.2021.08.005. Epub 2021 Sep 4.
• Lebastchi AH, George AK, Polascik TJ, Coleman J, de la Rosette J, Turkbey B, Wood BJ, Gorin MA, Sidana A, Ghai S, Tay KJ, Ward JF, Sanchez-Salas R, Muller BG, Malavaud B, Mozer P, Crouzet S, Choyke PL, Ukimura O, Rastinehad AR, Pinto PA. Standardized Nomenclature and Surveillance Methodologies After Focal Therapy and Partial Gland Ablation for Localized Prostate Cancer: An International Multidisciplinary Consensus. Eur Urol. 2020 Sep;78(3):371-378. doi: 10.1016/j.eururo.2020.05.018. Epub 2020 Jun 10.
• Borkowetz A, Blana A, Bohmer D, Cash H, Ehrmann U, Franiel T, Henkel TO, Hocht S, Kristiansen G, Machtens S, Niehoff P, Penzkofer T, Pinkawa M, Radtke JP, Roth W, Witzsch U, Ganzer R, Schlemmer HP, Grimm MO, Hakenberg OW, Schostak M. German S3 Evidence-Based Guidelines on Focal Therapy in Localized Prostate Cancer: The First Evidence-Based Guidelines on Focal Therapy. Urol Int. 2022;106(5):431-439. doi: 10.1159/000521882. Epub 2022 Feb 10.
• van der Poel HG, van den Bergh RCN, Briers E, Cornford P, Govorov A, Henry AM, Lam TB, Mason MD, Rouviere O, De Santis M, Willemse PM, van Poppel H, Mottet N. Focal Therapy in Primary Localised Prostate Cancer: The European Association of Urology Position in 2018. Eur Urol. 2018 Jul;74(1):84-91. doi: 10.1016/j.eururo.2018.01.001. Epub 2018 Jan 17.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2032

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: HIFU; Cryotherapy; RFA; IRE; Focal Therapy; VTP; Focal Brachytherapy; FLA
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: JUPITER2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Local Research Institutions may also use the data that entered in the database for further research, if their research project has been validated by the Scientific Committee. Local Research Institutions may export their data themselves using the exporting tool in Excel, CSV or SPSS format for data. In this case, Research Institutions access the data in the database and undertake to only use these data for the purposes of the research project that has been validated.

During the entire duration of the Jupiter Registry the data will remain pseudonymized in Castor EDC (cool-down period). During this timeframe data is kept in a protected state or with restricted access before it is made available for further analysis or actions such as anonymization or permanent deletion.

At the end of Jupiter registry, EAU-RF will anonymize the Study Data according to Regulations and to actual official European guidelines and create a "Data haven" ensuring that it is impossible to re-identify the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No