Clinical trial NCT06772116: Focal Therapy in Localized Prostate Cancer: a Prospective Registry
Official title: Jupiter Registry: Prospective Registry for Patients Undergoing Focal Therapy for Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate
Prostate Cancer
Keywords: Focal Therapy
HIFU
Cryotherapy
FLA
Focal Brachytherapy
IRE
VTP
RFA
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
Collaborators: name: European Association of Urology Research Foundation
First posted: 2025-01-13
Enrollment: 1000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of Negative Histological Findings for Prostate Cancer (PCa) on Target-Guided Biopsy of the Treated Area
timeFrame: 12 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 12-, 24-, 36-, 48- and 60-months after FT treatment
measure: Cancer-Specific Survival (CSS)
timeFrame: 12-, 24-, 36-, 48-, and 60-months after FT treatment
measure: Metastasis-Free Survival (MFS)
timeFrame: 12-, 24-, 36-, 48-, and 60-months after FT treatment
measure: FT Impact on Erectile Function
timeFrame: Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
measure: FT Impact on Lower Urinary Tract Symptoms
timeFrame: Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
measure: FT impact on Ejaculatory Function
timeFrame: Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
measure: FT impact on Quality of Life
timeFrame: Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
measure: Complications
timeFrame: at 3, 6, 9, and 12 months, and then annually until 60 months after treatment.
measure: Prostate Failure-Free Survival (pFFS)
timeFrame: 12-, 24-, 36-, 48- and 60-months after FT treatment
measure: Area Treated Failure-Free Survival (aFFS)
timeFrame: 12-, 24-, 36-, 48- and 60-months after FT treatment
measure: Progression free survival (PFS)
timeFrame: 12-, 24-, 36-, 48- and 60-months after FT treatment
measure: Salvage Treatments Rate
timeFrame: 12-, 24-, 36-, 48- and 60-months after FT treatment
measure: Rate of complications associated with Salvage Treatments
timeFrame: at 3, 6, 9, and 12 months, and then annually until 60 months after treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Eric Barret, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lyx Institute of Urology
name: Juan I Martinéz-Salamanca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.