Performance of Prostate MRI and Following Biopsy to Detect Prostate Cancer Recurrence After Focal Therapy
- Conditions
- Prostate Cancer
- Interventions
- Other: Targeted biopsies
- Registration Number
- NCT04773821
- Lead Sponsor
- Assistance Publique - H么pitaux de Paris
- 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.
- 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 recurrence after focal treatment of prostate cancer (PCa). The secondary objectives (all energy and according to the energy used) are: to describe the specific changes in prostate morphology after focal therapy ( normal presentation and recurrence in the treated and in the non-treated zone, all energy and according to the energy used),to evaluate the accuracy of MpMRI in the detection of residual PCa, in the treated zone, in the whole gland, to evaluate the performance of targeted biopsy and non targeted biopsy for the detection of prostate cancer recurrence, to evaluate the combination of targeted biopsy and non targeted biopsy for the detection of prostate cancer recurrence, to assess the number and amount of unnecessary non targeted biopsies taken during the follow up of men in focal therapy, to describe the morbidity of prostate non-targeted and targeted biopsy (number and severity of biopsy complications) for the detection of prostate cancer recurrence, to evaluate the impact of recurrence detection on patient management (number and type of salvage treatment),to evaluate the post treatment PSA levels including density, PSA nadir, and its goal in detection recurrence, to examine failures in order to learn potential future predictors of failure (all energy and according to the energy used, the initial location of the target on MRI and it's Gleason grade).The first objective of ancillary study is a central MRI lecture with 3 experts which will allow, performance and inter-observer reproducibility, to evaluate the percentage of cases that will be scored with agreement for concordant biopsy decision by the central radiology team and the site radiologist, to determine on the pre-treatment MRI predictive criteria of success or failure for focal therapy according of the energy used and to propose recommendations for MRI interpretation after FT. The second objective of ancillary study is a central pathology reading to evaluate the percentage of cases that will be scored with agreement on the Gleason score by the central pathologists and the site pathologist and to propose recommendations for histology interpretation post focal therapy. The study population will consist of men with low and intermediate risk prostate cancer (ISUP 1 and 2) who has already chosen to undergo focal treatment, and be willing and able to undergo MpMRI with subsequent prostate biopsies, as indicated. Patients will be enrolled at baseline by an urologist in one of urology units listed as investigation center. The focal treatment should take place no later than 3 months after inclusion visit. The follow-up visits will be planned at 3 month,6 month,12 and 13 months after focal treatment, consistently with patient usual care. In this study, all patients will have a MpMRI and MpMRI targeted biopsy in the presence of a lesion suggestive of recurrence.The statistical analysis is to compare the positive biopsy rate between non targeted and targeted in subject as his own control (with a 12-month relapse rate of 30%) assuming 18.25% positive with the standard method (H0) and 26.25% with the targeted method (H1) and 15% of discordant pairs. By simulation with a MacNemar test, with a bilateral alpha risk of 5% and power of 90% we need 260 subjects.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 260
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Arm Targeted biopsies 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
- Primary Outcome Measures
Name Time Method The detection rate of prostate cancer after focal treatment At 12 months 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
- Secondary Outcome Measures
Name Time Method Accuracy of MpMRI to detect PCa after focal treatment At 12 month after focal treatment PCa detection on the combination of Targeted Biopsy (TB) and Non targeted Biopsy (NTB) At 12 months after focal treatment To estimate the detection of Pca by the combination of the TB and NTB at once, and determinate the sensibility and the specificity in this configuration of combination.
Morbidity of prostate biopsy through the study completion, an average of 40 months Nature and severity of short term and long term biopsy complications: infection, hemorrhage, other
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 Prostate Specific Antigen (PSA) at 3 months, 6 months,12 months Prostate Specific Antigen density (PSAd) at 3 months and 12 months Number of positive MpMRI through the study completion, an average of 40 months Number of positive MpMRI define by a Likert score \> =3 in the treated and the non-treated zone
Localization of positive MpMRI through the study completion, an average of 40 months Localization of positive Mp MRI define by a Likert score \> =3 in the treated and the non-treated zone
Trial Locations
- Locations (11)
H么pital Foch
馃嚝馃嚪Suresnes, France
CH Chartres - H么pital Louis Pasteur
馃嚝馃嚪Chartres, France
CHU DIJON Francois Mitterrand
馃嚝馃嚪Dijon, France
CHRU Brest - H么pital de la Cavale Blanche
馃嚝馃嚪Brest, France
H么pital Cochin
馃嚝馃嚪Paris, France
CHU de Nice H么pital Pasteur 2
馃嚝馃嚪Nice, France
H么pital Tenon
馃嚝馃嚪Paris, France
Clinique La Croix du Sud Quint-Fonsegrives
馃嚝馃嚪Quint-Fonsegrives, France
Groupe Hospitalier Piti茅 Salp锚tri猫re
馃嚝馃嚪Paris, France
Institut Mutualiste Montsouris
馃嚝馃嚪Paris, France
CHU de Rennes - H么pital Pontchaillou
馃嚝馃嚪Rennes, France