Clinical trial · Interventional
Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer
Evaluation of the Feasibility and Tolerance of Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer
NCT03023345CI-TRIAL-00094609FOSTINEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to determine if trans-rectal microwave ablation of the index tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using MRI-transrectal ultrasound image registration.
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 |
|---|---|---|---|
| Low-Risk Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microwave trans rectal focal treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microwave
- description
- Microwave trans rectal focal treatment
- interventionNames
- Device: Microwave trans rectal focal treatment
Primary outcomes (1)
- measure
- Complete necrosis of the index tumor on prostate MRI
- timeFrame
- 7 days
Secondary outcomes (10)
- measure
- Margins of necrosis around the index tumor on prostate MRI
- timeFrame
- 7 days
- measure
- Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged from 45 to 76 years old ; * Life expectancy above 10 years ; * Diagnosis of prostate cancer confirmed on prostate biopsies ; * Low risk of progression, defined with D'Amico criteria : * T1c or T2a stage * Maximum Gleason score of 3+4, including targeted biopsies corresponding to less than 50% grade 4 for the tumor * Prostate Specific Antigen \<15 ng/mL * Detection of the index tumor with prostate MRI, characterized with targeted biopsies using MRI-transrectal ultrasound image registration ; * Patient accepting to be followed after the procedure using active surveillance protocol standards ; * Patient affiliated to national health care insurance ; * Free consent, informed and written, dated and signed by the patient and the investigator before enrollment. Exclusion Criteria: * Medical past history of prostatic surgery ; * Medical past history of radiotherapy or pelvic trauma ; * Medical past history of acute or chronic prostatitis * severe BPH-related urinary tract symptoms defined as an IPSS \>18 ; * Extra-capsular extension or seminal vesicle invasion on prostate MRI. * Tumor involvement \> 3 mm on systematic biopsies outside the tumor volume detected on MRI. * Tumor largest axis \> 20 mm on prostate MRI ; * Distance of less than 5 mm between the tumor and the rectum * Patient unable to understand the course of the study * History of allergy or non-tolerance to gadolinium salts used in MRI * Patient with a contraindication to performing an MRI * Person placed under safeguard of justice
References
Publications (1)
- RESULTBarry Delongchamps N, Schull A, Anract J, Abecassis JP, Zerbib M, Sibony M, Jilet L, Abdoul H, Goffin V, Peyromaure M. Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial. PLoS One. 2021 Jul 14;16(7):e0252040. doi: 10.1371/journal.pone.0252040. eCollection 2021. PMID 34260598