E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prostate cancer |
Tumeur de la prostate à haut risque |
|
E.1.1.1 | Medical condition in easily understood language |
Prostate cancer |
Cancer de la prostate |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029104 |
E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the ability of two imaging modalities (MRI BOLD and PET withFMISO) to demonstrate the hypoxic character of high-risk metastatic prostate tumors by comparing their results after prostatic segmentation with those from histological analysis of surgical specimens. |
Déterminer la capacité de deux modalités d’imagerie (IRM BOLD et TEP au FMISO) de mettre en évidence le caractère hypoxique de tumeurs de prostate à haut risque métastatique, en comparant leurs résultats après segmentation prostatique à ceux de l’analyse histologique des pièces opératoires. |
|
E.2.2 | Secondary objectives of the trial |
• Compare the inter-individual variability of hypoxia measurements according to two different modalities, • Provide imaging information for planning volumes in prostate tumor radiotherapy |
• Comparer la variabilité interindividuelle des mesures de l’hypoxie selon les différentes modalités, • Proposer des informations d’imagerie pour la planification des volumes en radiothérapie des tumeurs de prostate
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patient above 18 yrs old. • Prostate tumor with histological confirmed diagnosis and highly radiological suspected target on MRI • High risk patient : >T2c grade, Glasgow score > 7 and PSA > 20ng/ml • Surgical treatment chosen during multidisciplinary meeting • ECOG ≤2 • Patient must have undergone MRI with BOLD sequence less than 6 month prior surgery • Informed signed consent. • Member or beneficiary of a social security system. |
• Patient de plus de 18 ans, • Diagnostic anatomopathologique et radiologique initial de tumeur de prostate, • Patient estimé à haut risque : stade >T2c, score Gleason>7, PSA>20 ng/ml • Prise en charge chirurgicale retenue en RCP, • ECOG≤2, • Ayant eu une IRM avec la séquence BOLD datant de moins de 6 mois avant la chirurgie • Consentement écrit éclairé signé, • Patient affilié à un régime de sécurité sociale, |
|
E.4 | Principal exclusion criteria |
• Patient included in another clinical study • Geographical, social or psychological reasons preventing patient from submitting to the study’s medical monitoring • Patient deprive of liberty, adult subjects to legal protection or unable to give consent • Contraindication to MRI • Contraindication to gadolinium injection |
• Patient inclus dans une autre étude clinique, • Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques, • Patient privé de liberté et majeur faisant l’objet d’une mesure de protection légale ou hors d’état d’exprimer son consentement, • Contre-indication à l’IRM • Contre-indication à l’injection de chélates de gadolinium |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The main endpoint is the hypoxic character of the different prostate segments measured by imaging (MRI BOLD and PET at FMISO) and compare it to the results of the histological analysis of surgical specimens using histologic markers (HIF and CAIX) |
Le critère de jugement principal est le caractère hypoxique des différents segments prostatiques mesuré par imagerie (IRM BOLD et TEP au FMISO) et le comparer aux résultats de l’analyse histologique des pièces opératoires chez les patients présentant des tumeurs prostatiques de haut risque grâce à l’utilisation des marqueurs histologiques HIF et CAIX. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
• Compare the inter-individual variability of the hypoxia measurements according to the different modalities: an inter-individual analysis of the quantitative values will be carried out. • Compare the performance of multiparametric prostatic MRI with the BOLD sequence relative to the histological examination of the surgical specimens: an analysis of MRI performance will be performed by comparing ROC curves |
• Comparer la variabilité interindividuelle des mesures de l’hypoxie selon les différentes modalités : une analyse interindividuelle des valeurs quantitatives sera effectuée. • Comparer les performances de l’IRM prostatique multiparamétrique incluant la séquence BOLD par rapport à l’examen histologique des pièces opératoires : une analyse des performances de l’IRM sera effectuée par comparaison de courbes ROC
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |