Status:
UNKNOWN
Performance of Prostate MRI and Following Biopsy to Detect Prostate Cancer Recurrence After Focal Therapy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 prost...
Detailed Description
This trial is a multi-centric prospective and diagnostic study, comparative, not randomised. The main objective is to evaluate the value of Multiparametric MRI (MpMRI) and targeted biopsy in detecting...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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)
- Exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04773821
Start Date
June 2 2021
End Date
October 1 2024
Last Update
March 29 2022
Active Locations (11)
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1
CHRU Brest - Hôpital de la Cavale Blanche
Brest, France
2
CH Chartres - Hôpital Louis Pasteur
Chartres, France
3
CHU DIJON Francois Mitterrand
Dijon, France
4
CHU de Nice Hôpital Pasteur 2
Nice, France