E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
75 patients with the suspicion on PCa (elevated PSA and/or abnormal digital rectal exam) will receive a PSMA-PET following mpMRI. 25 patients with PIRADS 1-2 (probably benign disease), 25 patients with PIRADS 3 (equivocal disease) and 25 patients with PIRADS 4-5 (highly suspicious for malignancy) will be included in this explorative study. |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036921 |
E.1.2 | Term | Prostate carcinoma |
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 | 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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This explorative study aims to investigate the added value of a 18F-PSMA-PET to mpMRI in the detection of local prostate cancer lesions. |
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E.2.2 | Secondary objectives of the trial |
- Analyzing the different findings in terms of number and size on the two imaging modalities mpMRI and 18F-PSMA PET (e.g. multifocal tumors, extracapsular growth, vesicular seminalis infiltration etc.)
- Quantitative analyses: SUV measurements, tumor-background ratio’s and correlation of these quantitative parameters derived from 18F-PSMA PET to immuno-histological findings (e.g. PSMA expression level on tumor and non-tumor samples)
- Performing a cost-effective analysis for an additional 18F-PSMA PET scan based on final findings (in case 18F-PSMA PET improves the primary staging) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Suspicion for PCa (e.g. elevated PSA, suspicious rectal examination)
- Males ≥ 18 years
- ECOG 0-1
- Signed informed consent
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E.4 | Principal exclusion criteria |
- Prostate biopsy in the last 6 months
- History of prostate cancer
- Second active malignancy
- Any prior surgery in the pelvic area that might interfere with the scans (e.g. hip replacement surgery)
- Any medical condition that in the opinion of the investigator will affect patients’ clinical status when participating in this trial.
- Contra-indications for mpMRI or PET: claustrophobia or inability to lay still for the duration of the exam. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Within each of the three PIRADS groups (1-2, 3, 4-5) the fraction of patients in which the diagnosis based on mpMRI and 18F-PSMA PET might differ. For patients that have conflicting imaging outcomes, the imaging results are compared with the results of the (target) biopsy. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints will be the radiological state of the disease expressed in the difference in number and size of suspicious lesions, the extent of the disease on 18F-PSMA PET and mpMRI, correlation of the standardized uptake value of the PET to the PSMA expression of the immune-histopathology of the biopsy (e.g. ISUP score).(20) Another explorative endpoint is to perform a cost-effectiveness analysis for the additional use of 18F-PSMA PET based on the final findings. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | Yes |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |