Jupiter Registry: Prospective Registry for Patients Undergoing Focal Therapy for Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Rate of Negative Histological Findings for Prostate Cancer (PCa) on Target-Guided Biopsy of the Treated Area
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Rate of Negative Histological Findings for Prostate Cancer (PCa) on Target-Guided Biopsy of the Treated Area
时间窗: 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.
次要结局
- 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))
- FT impact on Ejaculatory Function(Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment))
- FT impact on Quality of Life(Baseline and at 12 months after FT treatment (optional: every 12 months until 60 months post-treatment))
- Complications(at 3, 6, 9, and 12 months, and then annually until 60 months after treatment.)
- Prostate Failure-Free Survival (pFFS)(12-, 24-, 36-, 48- and 60-months after FT treatment)
- Area Treated Failure-Free Survival (aFFS)(12-, 24-, 36-, 48- and 60-months after FT treatment)
- Progression free survival (PFS)(12-, 24-, 36-, 48- and 60-months after FT treatment)
- Salvage Treatments Rate(12-, 24-, 36-, 48- and 60-months after FT treatment)
- Rate of complications associated with Salvage Treatments(at 3, 6, 9, and 12 months, and then annually until 60 months after treatment.)