E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
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 | 10060862 |
E.1.2 | Term | Prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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) |
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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 compare 68Ga-PSMA-617 uptakes values between prostatic sextants for which histologic examination reveal a Gleason score 6, those for which histologic examination reveal a Gleason score 7(3+4) (favourable intermediate risk), for which histologic examination reveal a Gleason score 7(4+3) (unfavourable intermediate risk) and those for which histologic examination reveal a Gleason score 8 or more - To compare 68Ga-RM2 uptakes values between prostatic sextants for which histologic examination reveal a Gleason score 6, those for which histologic examination reveal a Gleason score 3+4 (favourable intermediate risk), those for which histologic examination reveal a Gleason score 4+3 (unfavourable intermediate risk) and for which histologic examination reveal a Gleason score 8 or more
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E.2.2 | Secondary objectives of the trial |
• To compare 68Ga-PSMA-617 and 68Ga-RM2-uptakes between prostatic sextants for which histologic examinations reveal a Gleason score 6 • To compare 68Ga-PSMA-617 and 68Ga-RM2-uptakes between prostatic sextants for which histologic examinations reveal a Gleason score 7(3+4) • To compare 68Ga-PSMA-617 and 68Ga-RM2-uptakes between prostatic sextants for which histologic examinations reveal a Gleason score 7(4+3) • To compare 68Ga-PSMA-617 and 68Ga-RM2-uptakes between prostatic sextants for which histologic examinations reveal a Gleason score 8 or more • To evaluate and compare 68Ga-PSMA-617 and 68Ga-RM2-uptakes in metastatic nodes • To estimate the association between 68Ga-PSMA-617 and 68Ga-RM2-uptakes and Gleason score both in vivo and ex vivo • To compare 68Ga-PSMA-617 uptake in healthy and pathological tissues at 1h and 2h after injection • To compare 68Ga-RM2 uptake in healthy and pathological tissues at 1h and 2h after injection • To compare micro-imaging data to immunohistochemistry
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients prostate cancer Candidate for radical prostatectomy after discussion in multidisciplinary committee Covered by the national health insurance system Written informed consent willingly obtained |
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E.4 | Principal exclusion criteria |
Any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…); Patient not candidate for radical prostatectomy and/or unable to benefit from surgery Freedom deprivated patient by judiciary or administrative decision Patient under legal protection or unable to express its own consent Patient within exclusion period from another clinical trial Known contraindication to radiopharmaceuticals and / or excipients
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E.5 End points |
E.5.1 | Primary end point(s) |
Median Standardized Uptake Value (SUV) of 68Ga-PSMA-617 and 68Ga-RM2 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Inclusion visit (V1) Follow up visit (V2)
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E.5.2 | Secondary end point(s) |
- Gleason score - Micro-imaging data : receptor density Bmax and local radioactive concentration expressed in cpm - Ex vivo immunohistochemistry data: Immunoreactive score (IRS) considering both percentage of stained cells and staining intensity.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Inclusion visit (V1) Follow up visit (V2) Last visit (V3 - Prostatectomy) |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Analyse histologique de la tumeur primitive |
histologic examination |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | |