Safety, Tolerability, Distribution & Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients Before Radical Prostatectomy (CAPEMCHAR)

Centre Hospitalier Universitaire de Nīmes

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Other: Administration of embolization beads

Study type: Interventional

Funder types: Other

Identifiers

NCT04423913

2019-001920-36 (EudraCT Number)

2019-A02946-51 (Registry Identifier)

NIMAO/2018-01/JF-01

Details and patient eligibility

About

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 Phase IIa pilot study is to evaluate the safety of performing prostate embolization with doxorubicin eluting-beads according to different loading doses. Four dose levels will be tested: doxorubicin-free beads to test the effect of embolization alone, 2.5 mg of doxorubicin (1/20 of the dose administered for liver cancers), 5 mg and 10 mg of doxorubicin.

The secondary objectives of the study are to evaluate the tolerance (functionnal questionaries at D0, D14 M1 and M3; collection of complications at D1, D5, D14, M1, M3; MRI at D14), evaluate the systemic diffusion of doxorubicin (doxorubinemia at D1), evaluate an early anti-tumor effect of the treatment (via a prostate-specific antigen test at D14 M1, M3 and magnetic resonance imaging at D14), describe the distribution of beads observed on the surgical specimen and evaluate the dose effect at 1 month and 3 months after surgery (via a prostate-specific antigen test at D14, M1, M3 and magnetic resonance imaging at D14).

Enrollment: 12 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Patients undergoing transarterial embolization of the prostate

Experimental group

Description:

Three patients will undergo transarterial embolization of the prostate using unloaded beads.

Treatment:

Other: Administration of embolization beads

Transarterial prostatic chemoembolization, 2.5 mg doxorubicin

Experimental group

Description:

Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 2.5 mg of doxorubicin.

Treatment:

Other: Administration of embolization beads

Transarterial prostatic chemoembolization, 5.0 mg doxorubicin

Experimental group

Description:

Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 5.0 mg of doxorubicin.

Treatment:

Other: Administration of embolization beads

Transarterial prostatic chemoembolization, 10.0 mg doxorubicin

Experimental group

Description:

Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 10.0 mg of doxorubicin.

Treatment:

Other: Administration of embolization beads