Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

NCT04582656 | Unknown

• 2 other identifiers: VIOLETTE2019-A00803-54
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 7

Brief Summary

Multicenter, prospective, European, single-arm, open-label, 12-month follow-up clinical trial. The purpose of this study is to evaluate the efficacy of a 3D cartography-based targeted microwave ablation for the treatment of the index lesion in patients with intermediate risk prostate cancer.

Conditions

Prostate Cancer

Keywords

Cancer; Prostate; Targeted treatment; Microwave

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with no evidence of cancer on targeted biopsy

  The proportion of patients with no evidence of cancer on targeted biopsy at 12 months, defined by a minimum of 2 targeted core biopsies taken from the index tumor site treated with microwave ablation for focal treatment of intermediate risk prostate cancer

  12 months

Secondary Outcomes (17)

• Proportion of radical salvage treatment

  12 months

• Time to radical salvage treatment

  12 months

• Proportion of patients with any cancer in the untreated area

  12 months

• Proportion of patients undergoing treatment for cancer in the untreated area

  12 months

• IPSS questionnaire

  7 days and 1, 6 and 12 months

Study Arms (1)

Targeted microwave ablation

EXPERIMENTAL

Targeted microwave transrectal or transperineal ablation of the prostatic index tumor using MRI-transrectal image registration and OBT fusion

Device: Targeted microwave ablation

Interventions

Targeted microwave ablation DEVICE

Targeted ablation of the index tumor with microwaves, by using either a transperineal or a transrectal approach

Targeted microwave ablation

Eligibility Criteria

• Age: 45 Years - 76 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged from 45 to 76 years old
• Patient diagnosed with an intermediate-risk prostate cancer, defined by:
• A T1c or T2a clinical stage
• A unique cancer focus of Gleason (3+4) (Grade Group 2)
• A PSA level \<20 ng/mL
• Patient suitable for IV sedation or general anesthesia and focal microwave ablation
• No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
• Known coagulopathy or bleeding disorders are controlled
• Free, informed and written consent, dated and signed before the enrollment and before any exam required by the trial
• Patient affiliated to social security regimen or beneficiary of such regimen for local regions

You may not qualify if:

• Past medical history of prostate surgery
• Past medical history of radiotherapy or pelvic trauma
• Past medical history of acute prostatitis
• Presently taking hormonal manipulation or androgen supplements.
• Past medical history of cancer in the 5 previous years, excluding a non-metastatic basal cell carcinoma of the skin
• Severe BPH-related urinary tract symptoms, defined by an IPSS score \>18
• Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit
• Contraindications for MRI exam
• Extracapsular cancer extension or seminal vesicles or pelvic lymph node invasion suspected on prostate MRI
• Presence of a clinically significant cancer with a Gleason score ≥8 (Grade Group ≥4)
• Tumor largest axis \>12 mm on the prostate MRI
• Distance between the cancer focus and the apex \<10 mm on the prostate MRI
• Distance between the cancer focus and the rectum \<5 mm on the prostate MRI
• Patient already participating in an interventional clinical trial
• Patient protected by law

Sponsors & Collaborators

• Koelis: lead

Study Sites (7)

Institut Jules Bordet

Brussels, 1000, Belgium

RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

RECRUITING

American Hospital of Paris

Neuilly-sur-Seine, 92200, France

RECRUITING

Hôpital de la Pitié-Salpêtrière (Assistance Publique - Hôpitaux de Paris)

Paris, 75013, France

RECRUITING

Hôpital Cochin (Assistance Publique - Hôpitaux de Paris)

Paris, 75014, France

RECRUITING

Urologie Nantes Clinique & Institut d'Urologie - Site Atlantis

Saint-Herblain, 44800, France

RECRUITING

Institut Claudius Regaud

Toulouse, 31100, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Roland VAN VELTHOVEN, MD

  Uro Science & Consulting

  STUDY CHAIR

Central Study Contacts

Damien FONTANELLI, MSc

CONTACT

+33 4 58 17 68 10; fontanelli@koelis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, single-arm, open-label, 12-month follow-up clinical trial

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 9, 2020
• Study Start: February 11, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (6)