Clinical trial · Interventional
Performance of Prostate MRI and Following Biopsy to Detect Prostate Cancer Recurrence After Focal Therapy
Performance of Prostate MRI and Targeted Biopsy to Detect Residual Prostate Cancer Following Focal Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Targeted biopsies | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- 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
- interventionNames
- Other: Targeted biopsies
Primary outcomes (1)
- measure
- The detection rate of prostate cancer after focal treatment
- timeFrame
- At 12 months after focal treatment
- description
- 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 outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria 1. Age \> 18 years 2. Detection of prostate cancer must have be done by combination of MRI plus biopsy following (EAU guidelines and French Guidelines) 3. Patient had no prior treatment for PCa 4. 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) 5. 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. 6. 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 7. Preoperative MRI and biopsy results will be mandatory 8. Participant must be willing to attend the follow up visits 9. Participant must be willing and able to attend follow-up MRI and prostate biopsies 10. Written informed consent 11. Affiliation to a French social security system excluding AME (Aide médicale d'état) Exclusion criteria 1. Hormone therapy within the past year 2. Prior pelvic radiotherapy 3. Focal brachytherapy 4. Concurrent participation in other interventional clinical studies with radical treatment of prostate cancer 5. Contraindications to undergo MpMRI or Trans rectal ultrasound TRUS-guided prostate biopsy (TRUS-Bx) 6. Patient deprived of liberty or under legal protection measure
References
Publications (0)
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