Evaluation of the Safety, Tolerability, Distribution and Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients at a High Risk of Recurrence Before Radical Prostatectomy: A Phase IIa Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
时间窗: Three months after the intervention
Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using unloaded beads.
时间窗: Three months after the intervention
Evaluation of post-operative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
时间窗: Three months after the intervention
Postoperative complications. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
时间窗: 3 months after the intervention
Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
次要结局
- Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin.(Day 14)
- Tolerance of prostate embolization using unloaded beads.(Day 14)
- Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin.(Day 14)
- Tolerance of prostate embolization using unloaded beads: Clavien-Dindo score(Day 14)
- Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score(Three months after embolization)
- Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score(Three months after embolization)
- Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score(Three months after embolization)
- Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test(Three months after embolization)
- Complete blood count for patients treated with beads loaded with 2.5 mg of doxorubicine(Three months after embolization)
- Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin.(Day 14)
- Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: Clavien-Dindo score(Day 14)
- Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score(Three months after embolization)
- Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score(Three months after embolization)
- Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score(Three months after embolization)
- Tolerance of prostate embolization using unloaded beads : 24h pad test(Three months after embolization)
- Prostate-specific antigen level in patients treated with unloaded beads.(Three months after embolization)
- Biological checkup for patients treated with beads loaded with 10.0 mg of doxorubicine(Three months after embolization)
- Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin:Clavien-Dindo score(Day 14)
- Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: Clavien-Dindo score(Day 14)
- Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score(Three months after embolization)
- Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test(Three months after embolization))
- Biological checkup for patients treated with beads loaded with 5.0 mg of doxorubicine(Three months after embolization)
- Complete blood count for patients treated with beads loaded with 10.0 mg of doxorubicine(Three months after embolization)
- Liver test for patients treated with beads loaded with 2.5 mg of doxorubicine(Three months after embolization)
- Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score(Three months after embolization)
- Biological checkup for patients treated with beads loaded with 2.5 mg of doxorubicine(Three months after embolization)
- Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine .(Three months after embolization)
- Liver test for patients treated with beads loaded with 10.0 mg of doxorubicine(Three months after embolization)
- Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score(Three months after embolization)
- Tolerance of prostate embolization using unloaded beads : IIEF-6 score(Three months after embolization)
- Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score(Three months after embolization))
- Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score(Three months after embolization)
- Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test(Three months after embolization)
- Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine .(Three months after embolization)
- Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine .(Three months after embolization)
- Complete blood count for patients treated with beads loaded with 5.0 mg of doxorubicine(Three months after embolization)
- Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 2.5 mg of doxorubicine(Three months after embolization)
- Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 10.0 mg of doxorubicine(Three months after embolization)
- Systemic dosage of free doxorubicin in blood in patients treated with beads loaded with 2.5 mg of doxorubicine(Day 1)
- Liver test for patients treated with beads loaded with 5.0 mg of doxorubicine(Three months after embolization)
- Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 5.0 mg of doxorubicine(Three months after embolization)