Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer
Condition: Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03531099
Sponsor: Hospices Civils de Lyon
Phase: Phase 3
- Age: minimum 50 Years maximum 80 Years
- Gender: Male
- Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
- Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have G8 score > 14.
- Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
- Only one Target tumor on MRI on a maximum of 2 contigous sextants. Case allowed:
- If more than one target tumor on MRI, only one of them must be confirmed by targeted prostate biopsies.
- If no target tumor on MRI, only 2 contigous sextants must be positive on prostate biopsies
- A maximum tumor length> 3 mm or at least 3 positive biopsies on all biopsies performed (randomized biopsies and/or MRI/Ultrasound Fusion-Guided Prostate Biopsy).
- Gleason 6 score (risk group 1 of the D'Amico classification).
- Tumor positioned so that a safety distance of at least 9 mm from external sphincter can be defined during HIFU-FOCAL treatment in prostate tissue around the target.
- PSA ≤ 15ng / ml.
- Patient affiliated with health insurance or beneficiary of an equivalent plan.
- Contraindications to treatment with HIFU-F:
- Tumor not accessible.
- Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
- History of pelvic irradiation
- Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
- Fistula of the urinary tract or rectum.
- Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
- Anatomical abnormality of the rectum or rectal mucosa.
- Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
- History of intestinal inflammatory pathology.
- Uro-genital infection in progress (the infection to be treated before HIFU treatment).
- Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
- Allergy to latex.
- Thickness of the rectal wall> 10mm.
- TURP indication. Bladder neck incision is allowed .
- Patient with a medical contraindication to Sonovue® injection.
- Patient with a medical contraindication on MRI.
- Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
- History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
- History of sclerosis of the bladder neck or urethral stenosis.
- Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy if randomized in HIFU-F arm).
- Patients with unstable neurological pathology.
- Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
- Legal person protected by law.
- Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.
View trial on ClinicalTrials.gov