Focal Therapy in Localized Prostate Cancer: a Prospective Registry

NCT06772116 | Not Yet Recruiting

• 1 other identifier: JUPITER2024
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate; Prostate Cancer

Keywords

Focal Therapy; HIFU; Cryotherapy; FLA; Focal Brachytherapy; IRE; VTP; RFA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Overall Survival (OS)

  12-, 24-, 36-, 48- and 60-months after FT treatment

• Cancer-Specific Survival (CSS)

  12-, 24-, 36-, 48-, and 60-months after FT treatment

• Metastasis-Free Survival (MFS)

  12-, 24-, 36-, 48-, and 60-months after FT treatment

• FT Impact on Erectile Function

  Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)

• FT Impact on Lower Urinary Tract Symptoms

  Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)

Study Arms (1)

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

Interventions

Focal Therapy PROCEDURE

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.

Also known as: Targeted Therapy for Prostate Cancer, Partial Gland Ablation (PGA), Energy-Based Ablative Therapy

Patients with intermediate-risk prostate cancer

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead
• European Association of Urology Research Foundation: collaborator

Related Publications (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.

  PMID: 32532513 BACKGROUND

• 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.

  PMID: 35144260 BACKGROUND

• 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.

  PMID: 34489140 BACKGROUND

• 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.

  PMID: 29373215 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Eric Barret, MD, PhD

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

• Juan I Martinéz-Salamanca, MD, PhD

  Lyx Institute of Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Maiolino, MD

CONTACT

+39 3204066478; jupiter.registry@gmail.com

Andrea Rodríguez Serrano, MD

CONTACT

+34 609 10 60 08; andrearodriguezserrano@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 13, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2032
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share