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EvaluatioN of HIFU Hemiablation and Short Term AndrogeN Deprivation Therapy Combination to Enhance Prostate Cancer Control.

NCT03845751 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-01-12

No results posted yet for this study

Summary

The current study aims to examine the hypothesis that combining the focal effects of HIFU with the systemic effects of androgen deprivation therapy might eradicate the prostatic cancer cells by targeting the 'visible' index focus (by HIFU) and the tumour surrounding microenvironment which may contain 'invisible' foci and aberrant PCa related signalling (by androgen deprivation therapy) to enhance oncological outcomes of HIFU hemi-ablation in men with localized PCa, and consequently reducing treatment failures.

Conditions

Interventions

DRUG

HIFU hemi-ablation combined with ADT.

Hemi-ablation of the cancer-harbouring prostatic lobe will be carried out using HIFU energy. Short-term 3-month ADT will be administered concomitantly. Short-term ADT is administered as a single subcutaneous injection of 3-month depot of 22.5 mg of leuprolide acetate (luteinizing hormone-releasing hormone \[LHRH\] agonist). The ADT protocol starts within 1 month prior to the scheduled HIFU session

Sponsors & Collaborators

  • University of Turin, Italy

    collaborator OTHER

  • Institut Mutualiste Montsouris

    lead OTHER

Principal Investigators

  • Lara RODRIGUEZ-SANCHEZ, Doctor · Institut Mutualiste Montsouris

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03845751 on ClinicalTrials.gov