E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prostate cancer |
Prostaat kanker |
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E.1.1.1 | Medical condition in easily understood language |
Prostate cancer |
Prostaat kanker |
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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 |
To head-to-head compare the imaging performance of 18F-fluciclovine PET/low-dose CT and 18F-DCFPyL PET/low-dose CT in patients with BCR of PCa after radical prostatectomy. |
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E.2.2 | Secondary objectives of the trial |
1.the detection rates on a patient-based analysis of 18F-DCFPyL and 18F-fluciclovine PET/CT stratified by PSA level (0.2-0.5; 0.51-1.0; 1.01-2.0 ng/mL); 2.the per-region detection rate of 18F-fluciclovine versus 18F-DCFPyL; 3.the side-effects of 18F-DCFPyL; 4.the inter-observer agreement.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male. Age ≥ 18 years. Histopathological confirmed prostate adenocarcinoma per original diagnosis. History of RARP. Biochemical recurrence of prostate cancer based on two consecutive measurable PSA levels of 0.2 -2.0 ng/mL. Ability to understand and sign the written informed consent form. Patients who can undergo all study procedures per investigator’s point of view.
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E.4 | Principal exclusion criteria |
Another active malignant tumor, except skin basal cell carcinoma. pN1 disease after ePLND. Any change in prostate cancer treatment between both PET/CT scans. History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection). History of salvage radiotherapy of the prostate bed. History of cryotherapy, high-intensity focused ultrasound (HIFU). Treatment with androgen deprivation therapy (ADT) in the past 30 days or ongoing. Unable to lie supine or still for imaging. Known allergy to investigational or reference products or to any excipients. Unable to provide written consent (linguistic or psychological inability). Uncooperative, in the Investigator’s opinion.
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E.5 End points |
E.5.1 | Primary end point(s) |
1.To compare the per patient detection rates (i.e., the proportion of patients with PET-positive findings) of 18F-fluciclovine (reference test) versus 18F-DCFPyL PET/CT (index test) for the identification of tumour location(s) patients with BCR of disease after RARP (PSA <0.2). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
We expect to complete the patient inclusion in 9 months. Data analysis and document writing will require 2-3 months. |
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E.5.2 | Secondary end point(s) |
2. the detection rates on a patient-based analysis of 18F-DCFPyL and 18F-fluciclovine PET/CT stratified by PSA level (0.2-0.5; 0.51-1.0; 1.01-2.0 ng/mL); 3. the per-region detection rate of 18F-fluciclovine versus 18F-DCFPyL; 4. the side-effects of 18F-DCFPyL; 5. the inter-observer agreement.
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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 | 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 | No |
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 | 1 |
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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The end of the study is defined as the last patients' last visit on the department of radiology and nuclear imaging from the Amsterdam UMC, VU University Medical Center, after a succesfully performed and completed PET/CT scan. |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |