Stereotactic Prostate Radiotherapy With Dose Escalation Focused on the "Dominant Intra-prostatic Lesion" (DIPL) Delineated by Multi-parametric MRI and 68Ga-PSMA PET (Prostate-SIB-PSMA) (Prostate-SIB)
Prostate Adenocarcinoma

About this trial
This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Localized, Intermediate risk, Initial care, Not operated, Integrated boost, multiparametric MRI, Dominant Intra-Prostatic Lesion (DIPL), 68Ga-PSMA PET, Safety, Dosimetric planning, Recurrence
Eligibility Criteria
Inclusion Criteria: Patient whose age is ≥ 18 years; Patient with intermediate-risk or high-risk prostate adenocarcinoma with a single severity criterion based on the NCCN classification Patient with at least 12 randomized biopsies N0 staging (CT or MRI or PET - choline) M0 (bone scan or PET - choline) with imaging workup less than 6 months old Dominant intra-prostate lesion identifiable on a recent multi-parametric MRI (< = 6 months) with an estimated volume < 40% of the entire prostate volume Informed patient who has signed a consent to participate in the study Patient enrolled in a health insurance plan (or beneficiary of such a plan) Exclusion Criteria: Patient with pre-therapeutic micturition disorders (IPSS score > 15) Patient with digestive inflammatory disease Patient with high risk prostate adenocarcinoma with more than one severity criteria based on the NCCN classification Prostate volume > 60 cc Patient with hip replacement Patient with a contraindication to the implantation of fiduciary implants (anticoagulants that cannot be stopped for gold bead implantation) Patient with a contraindication to MRI Patient who has had a trans-urethral resection of the prostate within 3 months prior to inclusion History of previous pelvic radiotherapy Patient with previous hormonal treatment Known hypersensitivity to the active substance or to the excipients used for the 68Ga-PSMA PET Patient with a contraindication to the administration of Lasilix Patient for whom follow-up does not seem feasible even in the short term Patient participating in another clinical trial that may interfere with the evaluation of the primary endpoint Patient under guardianship or deprived of liberty.
Sites / Locations
- Centre Marie Curie
- CAC-Clermont-Ferrand - Centre Jean Perrin
- Hospices Civils de Lyon (Hôpital Edouard Herriot)
- Centre Léon BérardRecruiting
Arms of the Study
Arm 1
Experimental
Radiotherapy
Stereotactic radiotherapy in 5 fractions (on alternate day) Whole prostate: 36.25 Gy - 7.25Gy/fraction GTV-RT (boost): target 50 Gy - 10 Gy/fraction