Phase II a study to evaluate the safety, tolerability, distribution and dose effect of neoadjuvant doxorubicin arterial embolization in patients with prostate cancer at high risk of recurrence before radical prostatectomy

Phase 1

• Conditions: patients with high-risk prostate cancer with a Gleason score of 9-10 on biopsy,multimodal treatment radical prostatectomy validated in CPR, managed in Hospital of Nîmes.; MedDRA version: 20.0Level: LLTClassification code 10007113Term: Cancer of prostateSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001920-36-FR
• Lead Sponsor: CHU de NIMES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-18
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

General inclusion criteria :
- The patient must have given free and informed consent and signed it.
- The patient must be affiliated or beneficiary of a health insurance scheme.
- The patient is at least 18 years old (=) and under 80 years old (<).
Inclusion criteria for the target population:
- Patient with high-risk prostate cancer with a Gleason score of 9-10 on biopsy, candidate for multimodal treatment with radical prostatectomy validated in CPR.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

- The patient has penile collateral that does not allow embolization as a precautionary principle (effect on erection unknown).
- The control scintigraphy after Injection of the albumin macroaggregates labelled with TC 99 m in each artery shows a non-target fixation (rectum).
5.3 Criteria for non-inclusion of research subjects
General non-inclusion criteria :
- The patient is participating in another study.
- The patient is in an exclusion period determined by a previous study.
- The patient is under the protection of justice, guardianship or curatorship
- Patients who are unable to express their consent may not be asked for this research (e. g. persons undergoing psychiatric care whose mental disorders make consent impossible...)
- The patient refuses to sign the consent.
- It is impossible to give informed information about the subject.
Criteria for non-inclusion regarding interfering diseases or associated conditions:
- Patient with metastatic disease from the outset.
- Contraindication to surgery
- Contraindication for MRI (pacemaker not MRI compatible, claustrophobia, metal device, total hip replacement).
- Patient with a history of bifemoral aortobypass or other vascular surgery that condemns endovascular access to prostate arteries.
- Patient with non-reversible hemostasis disorder: TP < 50%, ACT > 2 times the control, Platelet < 60 G/L.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified