E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prostate Cancer within prostate gland and metastatic prostate cancer in regional lymph nodes |
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E.1.1.1 | Medical condition in easily understood language |
Prostate Cancer within prostate gland and metastatic prostate cancer in regional lymph nodes |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007113 |
E.1.2 | Term | Cancer of prostate |
E.1.2 | System Organ Class | 100000004864 |
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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 |
. Assess the ability of 99mTc-MIP-1404 to detect prostate cancer within the prostate gland
. Assess the clinical safety of 99mTc-MIP-1404
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E.2.2 | Secondary objectives of the trial |
. Assess the ability of 99mTc-MIP-1404 to detect the extent and location of prostate cancer within the prostate gland.
.Assess the ability of 99mTc-MIP-1404 to detect metastatic prostate cancer within pelvic lymph nodes.
. Assess the ability of 99mTc-MIP-1404 to detect the specific location of metastatic prostate cancer within anatomic pelvic lymph node regions
. Assess the comparative performance of 99mTc-MIP-1404 against MRI for detection of prostate cancer within the prostate gland.
. Assess the comparative performance of 99mTc-MIP-1404 against MRI for detection of metastatic prostate cancer within pelvic lymph nodes. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must meet all of the following criteria to be enrolled in this study:
1. Male aged 21 years or older.
2. Ability to provide signed informed consent and willingness to comply with protocol requirements.
3. Biopsy confirmed presence of adenocarcinoma of the prostate gland.
4. At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130
5. Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.
6. Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc-MIP-1404 injection |
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E.4 | Principal exclusion criteria |
Subjects must not meet any of the following criteria to be enrolled in this study:
1. Participating would significantly delay the scheduled standard of care therapy.
2. Administered a radioisotope within 5 physical half lives prior to study drug injection.
3. Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
4. Have a contraindication for MR imaging.
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E.5 End points |
E.5.1 | Primary end point(s) |
. Assess the ability of 99mTc-MIP-1404 to detect prostate cancer within the prostate gland
. Assess the clinical safety of 99mTc-MIP-1404
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Post (after) histopathology processing of prostate and lymph node surgical samples |
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E.5.2 | Secondary end point(s) |
The relative diagnostic accuracy of disease detection in the prostate gland and in the local lymph nodes using 99mTc-MIP-1404 imaging versus MRI in this study population will be assessed as a secondary endpoint. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Post (after) histopathology processing of prostate and lymph node surgical samples |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.8.1.7.1 | Other trial design description |
multicenter, multi-reader, open-label trial |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Russian Federation |
United States |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |