E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Newly diagnosed prostate cancer, PET/CT scan used to stage newly diagnosed prostate cancer. |
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E.1.1.1 | Medical condition in easily understood language |
Evaluation of extent of disease in patients with newly diagnosed prostate cancer before decision of treatment offered to the patient |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
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 |
Men with a newly diagnosed intermediate or high risk (including locally advanced) prostate cancer or low risk with a clinical suspicion of metastases based on other findings, and before any treatment is initiated. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Men with a newly diagnosed intermediate or high risk (including locally advanced) prostate cancer or low risk with a clinical suspicion of metastases based on other findings, and before any treatment is initiated. • Has given informed consent to participate • Can read and understand provided patient information material in Danish • Biopsy verified, newly diagnosed and untreated PCa • Any, some, or all of the following features: o PSA ≥ 20 ng/ml OR o Gleason Score ≥ 4+3 OR o Tumor stage cT2c or above as determined by digital rectal exploration and/or transrectal ultrasonography OR o Suspicion of metastases as judged clinically • Staging by imaging is warranted |
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E.4 | Principal exclusion criteria |
• Consent not given • Inability to read and/or understand provided patient information in Danish • Previously given consent to this study withdrawn for any reason • Staging by imaging not warranted as judged clinically • Allergy towards NaF, PSMA or other contents in the solutions |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints (Group A vs. B) 1. Treatment strategies and progression-free survival 2. Quality of life measures |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the recruition period (3 years after start of inclusion). |
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E.5.2 | Secondary end point(s) |
Secondary endpoints Accuracy measures comprise analyses of Receiver Operating Curve and Area Under the Curve, sensitivity, specificity, positive and negative predictive values, and likelihood ratio. Biopsy of suspected metastatic lesions will be intended and used as a reference standard as well as a nadir unmeasurably low prostate-specific antigen blood sample. Accuracy analyses will be performed for: • PSMA-PET/CT vs. NaF-PET/CT for evaluation of bone metastases • PSMA-PET/MR vs. pathology in tumor staging • Overall survival (group A vs. group B) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After recruition period, and in the following years for overall survival. |
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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 | 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
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 | Yes |
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 |