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Performance of Prostate MRI and Following Biopsy to Detect Prostate Cancer Recurrence After Focal Therapy

NCT04773821 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2022-03-29

No results posted yet for this study

Summary

The management of localized prostate cancer remains controversial because of a risk of over diagnosis and over treatment. Focal therapy represents an approach to improve the therapeutic ratio of prostate cancer treatments. Focal therapy has been developed as minimally invasive procedure with the aim of providing equivalent oncological safety, reduced toxicity and improved functional outcomes. Multiparametric (mp) MRI Imaging may provide a reliable mean of monitoring for disease recurrence, and has been suggested as the most accurate imaging tool currently available for systematic detection of recurrence, pre-biopsy and preoperative mapping for an eventual salvage therapy. However, question about the performance of MRI and targeted biopsy in monitoring and defining successful therapy and follow up has been poorly evaluated. Modalities (standard biopsy, ablation zone biopsy vs targeted biopsy) and number of biopsies to be performed, depending on the results of MRI, remains unanswered due to a lack of available data.

We hypothesize that the combination of MpMRI of the prostate with subsequent targeted biopsy (TB) may improve detection of prostate cancer and may therefore improve the follow-up of men after focal therapy (FT) to better identify patients that need a salvage treatment and when.

Conditions

Interventions

OTHER

Targeted biopsies

Prostate MpMRI at 12 month (after PCa focal treatment in standard care) and targeted biopsies in the presence of lesion(s) suggestive(s) of recurrence

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Raphaële RENARD PENNA, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • France

Study Locations

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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 NCT04773821 on ClinicalTrials.gov