ProstateJRNCT06772116
Focal Therapy in Localized Prostate Cancer: a Prospective Registry
An observational study of Prostate and Prostate Cancer, run by Institut Mutualiste Montsouris.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate, Prostate Cancer
- What is being tested?
- Focal Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Feb 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate, Prostate Cancer
- Being tested
- Focal Therapy
- Keywords
- Focal Therapy, HIFU, Cryotherapy, FLA, Focal Brachytherapy, IRE, VTP, RFA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal TherapyProcedure or surgery
Also called Targeted Therapy for Prostate Cancer, Partial Gland Ablation (PGA), Energy-Based Ablative 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Focal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (13)
Overall Survival (OS)
Time from the date of focal therapy (FT) to the date of death from any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: at 3, 6, 9, and 12 months, and then annually until 60 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Collaborators
- European Association of Urology Research Foundation
- Responsible party
- Sponsor
- Investigators
- Eric Barret, MD, PhD, Principal investigator, Institut Mutualiste MontsourisJuan I Martinéz-Salamanca, MD, PhD, Principal investigator, Lyx Institute of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772116
- Sponsor's protocol ID
- JUPITER2024
- Acronym
- JR
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32532513Borkowetz 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.
PubMed 35144260Hopstaken 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.
PubMed 34489140van 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.
PubMed 29373215
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jupiter Registry: Prospective Registry for Patients Undergoing Focal Therapy for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT06772116
- Acronym / sponsor ID
- JR / JUPITER2024
- Conditions
- Prostate, Prostate Cancer
- Keywords
- Focal Therapy, HIFU, Cryotherapy, FLA, Focal Brachytherapy, IRE, VTP, RFA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Collaborators
- European Association of Urology Research Foundation
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with intermediate-risk prostate cancer | – | Procedure: Focal Therapyhe 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focal TherapyAlso: Targeted Therapy for Prostate Cancer, Partial Gland Ablation (PGA), Energy-Based Ablative TherapyPrimary 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. | Procedure or surgery | Patients with intermediate-risk prostate cancer |
Primary outcome
Rate of Negative Histological Findings for Prostate Cancer (PCa) on Target-Guided Biopsy of the Treated Area
Time frame: 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.
13 secondary outcomes
Overall Survival (OS)
Time frame: 12-, 24-, 36-, 48- and 60-months after FT treatment
Cancer-Specific Survival (CSS)
Time frame: 12-, 24-, 36-, 48-, and 60-months after FT treatment
Metastasis-Free Survival (MFS)
Time frame: 12-, 24-, 36-, 48-, and 60-months after FT treatment
FT Impact on Erectile Function
Time frame: Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
FT Impact on Lower Urinary Tract Symptoms
Time frame: Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
FT impact on Ejaculatory Function
Time frame: Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
FT impact on Quality of Life
Time frame: Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment)
Complications
Time frame: at 3, 6, 9, and 12 months, and then annually until 60 months after treatment.
Prostate Failure-Free Survival (pFFS)
Time frame: 12-, 24-, 36-, 48- and 60-months after FT treatment
Area Treated Failure-Free Survival (aFFS)
Time frame: 12-, 24-, 36-, 48- and 60-months after FT treatment
Progression free survival (PFS)
Time frame: 12-, 24-, 36-, 48- and 60-months after FT treatment
Salvage Treatments Rate
Time frame: 12-, 24-, 36-, 48- and 60-months after FT treatment
Rate of complications associated with Salvage Treatments
Time frame: at 3, 6, 9, and 12 months, and then annually until 60 months after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Background: PubMed 32532513Lebastchi 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.
- Background: PubMed 35144260Borkowetz 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.
- Background: PubMed 34489140Hopstaken 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.
- Background: PubMed 29373215van 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Barret, MD, PhD principal investigator
Institut Mutualiste Montsouris
Juan I Martinéz-Salamanca, MD, PhD principal investigator
Lyx Institute of Urology
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate and Prostate Cancer, run by Institut Mutualiste Montsouris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Maiolino, MD (+39 3204066478, jupiter.registry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Negative Histological Findings for Prostate Cancer (PCa) on Target-Guided Biopsy of the Treated Area (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06772116, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.