Phase II a study to evaluate the safety, tolerability, distribution and dose effect of neoadjuvant doxorubicin arterial embolization in patients with prostate cancer at high risk of recurrence before radical prostatectomy - CAPEMCHAR

CHU de NIMES0 个研究点目标入组 12 人开始时间: 2019年9月18日最近更新: 2021年4月5日

适应症

试验速览

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•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 (<).
•Inclusion criteria for the target population:
•- Patient with high-risk prostate cancer with a Gleason score of 9-10 on biopsy, candidate for multimodal treatment with radical prostatectomy validated in CPR.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•- 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 < 50%, ACT > 2 times the control, Platelet < 60 G/L.

发起方

CHU de NIMES