Feasibility Study on the Use of PET-MRI / 68Ga-PSMA Imaging for HIFU-focal Treatment in the Event of Recurrent Prostate Cancer After Radiotherapy - PSMA Study
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hospices Civils de Lyon
Age
50–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
1. Age ≥ 50 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have a G8 score \> 14.
2. Biological recurrence after prostate radiotherapy confirmed with de Phoenix criteria (nadir + 2 ng/mL).
3. No prior or present evidence of lymph node metastasis, soft tissue metastasis or bone metastasis, assessed by the current radiographic exam (PET-Choline) AND the PET-MRI/68Ga-PSMA before Focal-HIFU.
4. Local prostate cancer recurrence confirmed by:
* A multiparametric MRI showing a single tumor in the prostate gland at most 3 contiguous sextants confirmed by biopsies (Index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by biopsies.
* Index tumor confirmed by the PET-MRI/68Ga-PSMA.
5. PSA ≤ 10ng/ml.
6. 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.
7. Patient affiliated with health insurance or beneficiary of an equivalent plan.
You may not be if
1. Contraindications to Focal-HIFU treatment.
2. Patient with a medical contraindication to Sonovue® injection.
3. Patient with a medical contraindication to MRI.
4. History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
5. History of sclerosis of the bladder neck or urethral stenosis.
6. Patient at risk of bleeding according to medical advice. Patient with anticoagulants therapy must receive a treatment relay.
7. Patients with unstable neurological pathology.
8. 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.
9. Legal person protected by law.
10. Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.
Clareo Health | Feasibility Study on the Use of PET-MRI / 68Ga-PSMA Imaging for HIFU-focal Treatment in the Event of Recurrent Prostate Cancer After Radiotherapy - PSMA Study
