E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prostate cancer suspected clinically and on the basis of elevated serum Prostate Specific Antigen (PSA) levels and PSA density and with result of multiparametric Magnetic Resonance Imaging (mpMRI) of prostate gland scored ≤3 according to PI-RADS v2.1 |
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E.1.1.1 | Medical condition in easily understood language |
Prostate cancer suspected clinically and on the basis of elevated serum PSA levels and PSA density and with negative or equivocal result of Magnetic Resonance Imaging (MRI) of prostate gland |
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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 | 10053838 |
E.1.2 | Term | Free prostate-specific antigen increased |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10050321 |
E.1.2 | Term | Prostate examination |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 | 10029096 |
E.1.2 | Term | Neoplasm prostate |
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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10004385 |
E.1.2 | Term | Benign neoplasm of prostate |
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 analyse the patient-based sensitivity of florastamin (18F) PET/CT for localisation of csPCa in patients with elevated serum PSA levels and/or PSA density and with clinical suspicion of PCa and with report of mpMRI of prostate gland scored ≤3 according to PI-RADS v2.1 |
• Analyse der patientenbasierten Empfindlichkeit von Florastamin (18F) PET / CT für die Lokalisierung von csPCa bei Patienten mit erhöhten Serum-PSA-Spiegeln und / oder PSA-Dichte und mit klinischem Verdacht auf PCa und mit einem Bericht über mpMRI der Prostata, der mit ≤3 bewertet wurde zu PI-RADS v2.1 |
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E.2.2 | Secondary objectives of the trial |
• To assess the patient anf the site-based specificity and positive and negative predictive value and site-based sensitivity of florastamin (18F) PET/CT for localisation of csPCa • To assess the net reclassification index (NRI) of florastamin (18F) for localisation of csPCa • To assess the frequency of impact of florastamin (18F) PET/CT on diagnostic thinking • To assess the frequency of impact of florastamin (18F) PET/CT on patient management. • To correlate the patient based diagnostic performance of florastamin (18F) PET/CT in detection of csPCa with prostate health index (PHI) when available • To correlate quantitative uptake of florastamin (18F) with diagnostic performances in localization of csPCa. • To confirm the safety profile of florastamin (18F) • To correlate quantitative uptake of florastamin (18F) with histopathological results • To refine the interpretation criteria of florastamin (18F) PET/CT |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male gender; • Age ≥18 years; • PSA ≥10ng/mL and/or PSAD≥0.26 ng/mL2; • PI-RADS v2 ≤3 report of mpMRI performed less than 3 months prior inclusion; • Availability of mpMRI data for centralized reading; • Patient scheduled for biopsy or radical prostatectomy; • Signed informed consent; • Absence of any of the exclusion criteria.
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E.4 | Principal exclusion criteria |
• Absence of any of the inclusion criteria; • Hypersensitivity to active substance or any of excipients of investigational medicinal product • Life expectancy <6 months; • ECOG performance status >2. • Concomitant active malignancy • Past history of confirmed prostate cancer. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Localisation of csPCa by florastamin (18F) PET/CT in patients with elevated serum PSA levels and/or PSA density and with clinical suspicion of PCa. Percentage of true positive (TP) patients among TP divided by (TP + false negative (FN)). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint will be evaluated on the basis of standard of truth during six month follow-up period in each included subject. For whole study, the primary endpoint will be assessed six months after inclusion of the last evaluable patient. |
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E.5.2 | Secondary end point(s) |
• Percentage of true negative (TN) patients among TN divided by (TN + false positive (FP)). • Percentage of true positive (TP) sites among TP divided by (TP + false negative (FN)). • NRI of florastamin (18F). • Percentage of patients in whom the initially scheduled diagnostic thinking has been modified based on florastamin (18F) PET/CT results. • Percentage of patients in whom the therapeutic management of PCa has been modified based on florastamin (18F) PET/CT results. • Correlation of patient based diagnostic performance of florastamin (18F) PET/CT with PHI when available. • Quantitative uptake of florastamin (18F) by csPCa • Percentage adverse events observed during the first 24 hours florastamin (18F) administration. • Correlation of quantitative uptake of florastamin (18F) with histopathological results. • Establishment of interpretation criteria. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Impact of florastamin (18F) PET/CT on diagnostic thinking • Impact of florastamin (18F) PET/CT on patient management • Incidental finding(s) of florastamin (18F) PET/CT • Abnormality of biodistribution of florastamin (18F) • Adverse reaction(s) related with use of florastamin (18F) |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
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 |
Prospective comparative trial with diagnostic product with blind reading and with standard of truth |
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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 | Yes |
E.8.2.3.1 | Comparator description |
multiparametric Magnetic Resonance Imaging (mpMRI) |
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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
| 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
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Completion of standard of truth and six-month clinical follow-up period in last included and evaluable patient. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |