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-lesion basis, using a composite SOR.
Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for lesions 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. Unable to lie supine for imaging
8. Known allergy to investigational or reference products or to any excipients
9. Unable to provide written consent (linguistic or psychological inability)
10. Participation in another clinical study within one month prior to inclusion
11. Uncooperative, in the Investigator's opinion.
12. 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 a surrogate SOR. The SOR will be made of an appropriate combination of tests performed in clinical routine practice during the following 6 to 7 months after the last 18F-tracer injection including: clinical data, PSA, histopathology and follow-up imaging exams. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 to 7 months of follow-up after the last tracer administration |
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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-lesion basis, using composite SOR.
• Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for lesions using composite SOR.
• Safety of 18F-DCFPyL versus that of 18F-FCH
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 to 7 months of follow-up after the last tracer administration |
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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 | 12 |
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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The patient participation will end with the recording of adverse events occuring within 24 hours after the last tracer injection.Study will end 7 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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |