Safety, Tolerability, Distribution & Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients Before Radical Prostatectomy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Centre Hospitalier Universitaire de Nīmes
Age
18–80
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Patients must have given written informed consent.
Patients must be affiliated to or benefit from a health insurance scheme.
Patients with a high-risk prostate cancer with a Gleason score of 9-10 on the biopsy, candidate for a multimodal treatment with radical prostatectomy validated at the multidisciplinary meeting.
Patients with a normal blood count.
Patients with a normal liver function test.
Patients with an electrocardiogram including left ventricle ejection fraction (ventricular scintigraphy or echocardiography) and an echocardiogram allowing us to rule out heart disease.
Patient must be completely recovered from acute toxicities (such as stomatitis, neutropenia, thrombopenia and generalized infections) caused by a previous cytotoxic treatment.
OMS/ECOG score≤1 (to guard against a possible loss of therapeutic opportunity related to a delay in surgery caused by chemo-embolization).
You may not be if
Patients who are taking part in another study.
Patients in an exclusion period determined by a previous study.
Patients under legal guardianship, curatorship or tutorship.
Patients not in condition to be able to express his consent (e.g. patient undergoing psychiatric treatment with mental disorders)
Patients who refuse to sign the consent form.
Patients for whom it is impossible to give clear information. • Patient already has a metastatic disease.
Patients who have contraindications for surgery.
Patients with a rectal or vesicular collateral pathology that cannot be excluded or a collateral penile pathology which, by precaution, would not allow embolization (unknown effect on the erection in the event of arterial exclusion).
Patients with a contraindication for magnetic resonance imaging (pacemaker incompatible with MRI, claustrophobia, metal apparatus, total hip prosthesis).
Patients with a past history of aortobifemoral bypass procedure or other vascular surgery making endovascular access to the prostate arteries impossible.
Patients with irreversible hemostasis disorder: TP \< 50%, TCA \> twice the control, Platelets \< 60 G/L.
Patients with contraindications as mentioned in the Summary of Product Characteristics for Doxorubicin.
Clareo Health | Safety, Tolerability, Distribution & Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients Before Radical Prostatectomy
