patients with high-risk prostate cancer with a Gleason score of 9-10 on biopsy,multimodal treatment radical prostatectomy validated in CPR, managed in Hospital of Nîmes. MedDRA version: 20.0 Level: LLT Classification code 10007113 Term: Cancer of prostate System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ADRIBLASTINE 50 mg, poudre pour solution injectable en flacon
Product Name: Chlorhydrate de Doxorubicine 50mg
Pharmaceutical Form: Powder for concentrate for solution for injection/infusio
Sponsors
CHU de NIMES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General inclusion criteria : - The patient must have given free and informed consent and signed it. - The patient must be affiliated or beneficiary of a health insurance scheme. - The patient is at least 18 years old (=) and under 80 years old (=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: Exclusion criteria: - The patient has penile collateral that does not allow embolization as a precautionary principle (effect on erection unknown). - The control scintigraphy after Injection of the albumin macroaggregates labelled with TC 99 m in each artery shows a non-target fixation (rectum). 5.3 Criteria for non-inclusion of research subjects General non-inclusion criteria : - The patient is participating in another study. - The patient is in an exclusion period determined by a previous study. - The patient is under the protection of justice, guardianship or curatorship - Patients who are unable to express their consent may not be asked for this research (e. g. persons undergoing psychiatric care whose mental disorders make consent impossible...) - The patient refuses to sign the consent. - It is impossible to give informed information about the subject. Criteria for non-inclusion regarding interfering diseases or associated conditions: - Patient with metastatic disease from the outset. - Contraindication to surgery - Contraindication for MRI (pacemaker not MRI compatible, claustrophobia, metal device, total hip replacement). - Patient with a history of bifemoral aortobypass or other vascular surgery that condemns endovascular access to prostate arteries. - Patient with non-reversible hemostasis disorder: TP 2 times the control, Platelet < 60 G/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate the tolerance to prostatic embolization with doxorubicin-loaded beads according to the dose of chemotherapy used;Secondary Objective: describe the distribution of beads, evaluate post-embolization and post-operative complications, the evolution at 1 and 3 months after surgery of the biological response (PSA assay), functional consequences (symptoms, incontinence, erectile dysfunction, quality of life). ;Primary end point(s): Number of serious adverse events with non-target necrosis type evaluated at D8 the day after embolization (clinical examination for non-target necrosis: severe bladder or rectal pain, rectorragy or abundant hematuria, fever) then D12 (by telephone) and D21, 2 weeks after embolization by MRI (bladder or rectal necrosis, fistula, abscess) and during surgery. Collection of complications at D30 post-operatively and M3;Timepoint(s) of evaluation of this end point: Number of serious adverse events with non-target necrosis type evaluated at D8 the day after embolization (clinical examination for non-target necrosis: severe bladder or rectal pain, rectorragy or abundant hematuria, fever) then D12 (by telephone) and D21, 2 weeks after embolization by MRI (bladder or rectal necrosis, fistula, abscess) and during surgery. Collection of complications at D30 post-operatively and M3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - MRI examination 1, 5 or 3 Tesla of the prostate (multiparametric acquisition with T2 morphological sequence, functional in diffusion and dynamic injection of contrast agent) at D21, i.e. 2 weeks after embolization: volume modification, necrosis zone. - Early post-operative complications during hospitalization: description and classification of Clavien-Dindo: haematomas, arterial wound with bleeding, bladder wound, rectal wound, wall abscess, deep abscess... - Early follow-up of symptoms and functional consequences on 21 days, 14 days after embolization and before surgery: administration of IPSS, IIEF-6, EORTC-QLQ C30 questionnaires. - A M1 and M3 after surgery: collection of adverse events classified as Clavien-Dindo - A M1 and M3 after surgery, monitoring of symptoms and functional consequences: International Prostate Symtom Score (IPSS), Pad Test 24h, variation in erectile function score (IIEF-6), quality of life measured using the EORTC QLQ-C30 prostate module questionnaire. B. Blood determination of doxorubicin the day after embolization before discharge from hospital. C. Determination of blood PSA at D21 before surgery. Conduct an MRI examination at D21 (target modification (PiRads classification), target size reduction). D. Anatomical-pathological examination of the operating room: total necrosis of the tumour, partial necrosis > 50% of the tumour volume, minimal necrosis 50% of the tumour volume, minimal necrosis < 50% of the tumour volume, E. Blood PSA at 1 month and 3 months post surgery | — |
Countries
France
Contacts
Public ContactDRCI
CHU de NIMES
Outcome results
None listed