E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with histopathologically confirmed prostate adenocarcinoma per original diagnosis and subsequent definitive therapy, with first biochemical recurrence |
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E.1.1.1 | Medical condition in easily understood language |
Patients with confirmed prostate cancer treated with radiotherapy or surgery with first recurrence (increase in PSA level) |
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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 | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036911 |
E.1.2 | Term | Prostate cancer recurrent |
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 |
Per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT |
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E.2.2 | Secondary objectives of the trial |
Impact on patient treatment/management. Per-region detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT. Sensitivity and specificity of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT on a per-patient and per-region basis, using a composite SOR. Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for regions using a composite SOR. Safety of 18F-DCFPyL versus that of 18F-FCH
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male. 2. Age superior or equal to 18 years. 3. Histopathological proven prostate adenocarcinoma per original diagnosis. 4. First suspected recurrence of prostate cancer based on rising prostate-specific antigen (PSA) after initial curative therapy with radical prostatectomy of PSA ≥ 0.2 ng/mL confirmed by a subsequent PSA value of ≥0.2 ng/mL or with radiation therapy (external beam or brachytherapy) of PSA > 2 ng/mL above the nadir after therapy regardless of the serum concentration of the nadir. 5. Able and willing to provide informed consent and comply with protocol requirements 6. Patient who can undergo all study procedures per Investigator’s point of view 7. Patient with social insurance cover. |
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E.4 | Principal exclusion criteria |
1. ECOG > 2 2. History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection) 3. History of adjuvant radiotherapy 4. History of cryotherapy, high-intensity focused ultrasound (HIFU) 5. Other active malignant tumour 6. Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or ongoing 7. Treatment with colchicine in the past 8 days or ongoing 8. Treatment with hematopoietic colony stimulating factors (CSF) in the past 5 days or ongoing 9. Unable to lie supine for imaging 10. Known allergy to investigational or reference products or to any excipients 11. Unable to provide written consent (linguistic or psychological inability) 12. Participation in another clinical study within one month prior to inclusion 13. Uncooperative, in the Investigator's opinion. 14. Subjects deprived of their freedom by administrative or legal decision or who are under guardianship
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E.5 End points |
E.5.1 | Primary end point(s) |
Per-patient detection rate of 18F-DCFPyL PET/CT and 18F-FCH PET/CT for recurrence (either local, regional or distant), based on the independent central reading. The detection rate is defined as the ratio between the number of patients defined as positive at patient level by at least 2 independent readers, and the total number of assessed patients. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Last patient last tracer injection |
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E.5.2 | Secondary end point(s) |
• Impact on patient treatment/management. • Per-region detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT. • Sensitivity and specificity of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT on a per-patient and per-region basis, using composite SOR. • Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for regions using composite SOR. • Safety of 18F-DCFPyL versus that of 18F-FCH.
The SOR will be made of an appropriate combination of tests performed in clinical routine practice during the following 10 months after the last 18F-tracer injection including: clinical data, PSA, histopathology and follow-up imaging exams. The per-region detection rate is the ratio between the number of patients defined as positive at region level for a given region by at least 2 independent readers and the total number of assessed patients. The per-patient sensitivity is the ratio between the number of patients defined as positive at patient level by at least 2 independent readers and the total number of patients assessed as positive at patient level by the truth panel. The per-region sensitivity is the ratio between the number of patients defined as positive at region level for a given region by at least 2 independent readers and the total number of patients assessed as positive at region level for the given region by the truth panel. The per-patient specificity is the ratio between the number of patients defined as negative at patient level by at least 2 independent readers and the total number of patients assessed as negative at patient level by the truth panel. The per-region specificity is calculated for each region as the ratio between the number of patients defined as negative at region level for the considered region by at least 2 independent readers and the total number of patients assessed as negative at region level for the considered region by the truth panel. Per-patient and per-region specificity and sensibility will also be computed for each reader eparately. The per-region concordance rate is defined as the ratio between the number of regions defined as positive at region level by both the independent reading and the truth panel + the number of regions defined as negative at region level by both the independent reading and the truth panel and the total number of assessed regions.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
10 months of follow-up after last patient last tracer injection. |
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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 | 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 | 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 | Yes |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
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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Patient active participation will end 72 hours after the last tracer injection. Study will end 10 months after last patient completing the study.This period allows to collect sufficient data regarding clinical care of patients to assess the clinical value of performing PET scan with 18F-DCFPyl. Those data will be submitted to the truth panel experts in order to assess the impact/clinical meaning of the 18F-DCFPyl on patient treatment/management. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |