Status:
TERMINATED
Safety, Tolerability, Distribution & Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients Before Radical Prostatectomy
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE2
Brief Summary
Our hypothesis is that the doxorubicin eluting-beads currently used in hepato-oncology might be applicable to high-grade prostate cancer before radical prostatectomy. The primary objective of this Ph...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04423913
Start Date
May 4 2022
End Date
October 31 2022
Last Update
March 27 2023
Active Locations (1)
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1
Nîmes University Hospital
Nîmes, Gard, France, 30029