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NCT06772116Not yet recruiting

Focal Therapy in Localized Prostate Cancer: a Prospective Registry

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

Source: ClinicalTrials.gov · Last updated 13 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
27 Dec 2024
Start date
Feb 2025
Primary completion date
Feb 2028
Lead sponsor
Institut Mutualiste Montsouris
NCT number
NCT06772116

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From Feb 2025 to the primary completion date, Feb 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with intermediate risk treated with focal therapy without a previous targeted + systematic prostate biopsy with US-MRI fusion technique.
  • Previous treatment of PCa (excluded a period of Active Surveillance)

Other illness

  • Primary focal treatment of PCa ISUP 2 or 3 in areas of prostate without evidence of lesions on MRI (MRI-invisible prostate cancer)
  • Metastatic hormone-sensitive prostate cancer (mHSPC)
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

Age

  • Life expectancy \<10 years

Other

  • 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
  • High risk PCa based on EAU risk groups.
  • Locally advanced PCa

Who the study is looking for

  • 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

Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.