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

NCT04773821 | Unknown

• 2 other identifiers: APHP1911262020-A01466-33
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 11

Brief 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

Prostate Cancer

Keywords

Prostate Cancer; Focal Therapy; Multiparametric MRI; Prostate Specific Antigen; Prostate Specific Antigen density; Standard Biopsy; Targeted Biopsy; Trans rectal ultrasound; Trans rectal ultrasound guided biopsy; Non targeted Biopsy (Standard biopsy and zonal ablation); Cryotherapy; High-intensity focused ultrasound (HIFU); Irreversible electroporation; Laser ablation therapy

Outcome Measures

Primary Outcomes (1)

• The detection rate of prostate cancer after focal treatment

  To compare the detection rates obtained by both standard (STB) and targeted methods (TB), both types of biopsy being done on the same subjects

  At 12 months after focal treatment

Secondary Outcomes (10)

• PCa detection on the combination of Targeted Biopsy (TB) and Non targeted Biopsy (NTB)

  At 12 months after focal treatment

• Morbidity of prostate biopsy

  through the study completion, an average of 40 months

• Number of salvage treatment by focal therapy

  through the study completion, an average of 40 months

• Number of salvage treatment by radical prostatectomy

  through the study completion, an average of 40 months

• Number of salvage treatment by external radiotherapy

  through the study completion, an average of 40 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

All men patients with low and intermediate risk prostate cancer (ISUP 1 and 2) who has already chosen to undergo focal treatment, in the referral centers and responding to the inclusion criteria will be included after obtaining their writing consent. Follow-up visits are planned at 3, 6,12 and 13 month from the date of the focal treatment consistently with usual care. All patients will have a MpMRI and MpMRI targeted biopsy in the presence of a lesion suggestive of recurrence at 12 months. The subject will be his own control

Other: Targeted biopsies

Interventions

Targeted biopsies OTHER

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

Experimental Arm

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Detection of prostate cancer must have be done by combination of MRI plus biopsy following (EAU guidelines and French Guidelines)
• Patient had no prior treatment for PCa
• The patient could be classified as low- or intermediate-risk, according to D'Amico's 2003 \[15\] risk group categories: T1c, T2a, PSA less than 20ng/ml, with Gleason Grade of 6 (3+3) or 7 (3+4 ) (ISUP 1 and ISUP 2)
• Management decisions should be made after all treatments have been discussed in a multidisciplinary team and after the balance of benefits and side-effects of appropriate therapy modalities has been considered together with the patient.
• Patient informed of treatment options and have already chosen to undergo focal treatment (focal, quadrant or hemi-ablation) by cryotherapy, high-intensity focused ultrasound (HIFU), irreversible electroporation, laser ablation therapy (including photodynamic therapy) and microwave
• Preoperative MRI and biopsy results will be mandatory
• Participant must be willing to attend the follow up visits
• Participant must be willing and able to attend follow-up MRI and prostate biopsies
• Written informed consent
• Affiliation to a French social security system excluding AME (Aide médicale d'état)

You may not qualify if:

• Hormone therapy within the past year
• Prior pelvic radiotherapy
• Focal brachytherapy
• Concurrent participation in other interventional clinical studies with radical treatment of prostate cancer
• Contraindications to undergo MpMRI or Trans rectal ultrasound TRUS-guided prostate biopsy (TRUS-Bx)
• Patient deprived of liberty or under legal protection measure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (11)

CHRU Brest - Hôpital de la Cavale Blanche

Brest, France

NOT YET RECRUITING

CH Chartres - Hôpital Louis Pasteur

Chartres, France

RECRUITING

CHU DIJON Francois Mitterrand

Dijon, France

RECRUITING

CHU de Nice Hôpital Pasteur 2

Nice, France

NOT YET RECRUITING

Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Hôpital Tenon

Paris, 75184, France

RECRUITING

Hôpital Cochin

Paris, France

RECRUITING

Institut Mutualiste Montsouris

Paris, France

RECRUITING

Clinique La Croix du Sud Quint-Fonsegrives

Quint-Fonsegrives, France

RECRUITING

CHU de Rennes - Hôpital Pontchaillou

Rennes, France

NOT YET RECRUITING

Hôpital Foch

Suresnes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Raphaële RENARD PENNA, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphaële RENARD PENNA, MD, PhD

CONTACT

142176329; raphaele.renardpenna@aphp.fr

Luc CORMIER, MD, PhD

CONTACT

684118509; luc.cormier@chu-dijon.fr

Study Design

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

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 26, 2021
• Study Start: June 2, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 29, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)