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

NCT ID: NCT04423913

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2022-10-31

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 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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients undergoing transarterial embolization of the prostate

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

Group Type: EXPERIMENTAL

Administration of embolization beads

Intervention Type: OTHER

Patients will receive embolization beads, loaded with doxorubicin or not.

Transarterial prostatic chemoembolization, 2.5 mg doxorubicin

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

Group Type: EXPERIMENTAL

Administration of embolization beads

Intervention Type: OTHER

Patients will receive embolization beads, loaded with doxorubicin or not.

Transarterial prostatic chemoembolization, 5.0 mg doxorubicin

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

Group Type: EXPERIMENTAL

Administration of embolization beads

Intervention Type: OTHER

Patients will receive embolization beads, loaded with doxorubicin or not.

Transarterial prostatic chemoembolization, 10.0 mg doxorubicin

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

Group Type: EXPERIMENTAL

Administration of embolization beads

Intervention Type: OTHER

Patients will receive embolization beads, loaded with doxorubicin or not.

Interventions

Administration of embolization beads

Patients will receive embolization beads, loaded with doxorubicin or not.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anissa MEGZARI

Role: STUDY_DIRECTOR

CHU de Nîmes, Place du Professeur Debré, 30029 Nîmes Cedex

Locations

Nîmes University Hospital

Nîmes, Gard, France

Countries

France

Other Identifiers

2019-001920-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2019-A02946-51

Identifier Type: REGISTRY

Identifier Source: secondary_id

NIMAO/2018-01/JF-01

Identifier Type: -

Identifier Source: org_study_id