E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prostate cancer (PCa) is the most common malignancy amongst men in Western
countries. In order to select the most suitable treatment for patients diagnosed with PCa, it is important
to stage accurately. Both 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT are currently mostly used to detect
recurrence in treated PCa, while the diagnostic value in detecting lymph node metastasis in primary
prostate cancer is not yet clear. |
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E.1.1.1 | Medical condition in easily understood language |
To identify the diagnostic value of PSMA-PET-CT and FACBC-PET-CT in detecting lymph node metastases in patients with primary prostate cancer. |
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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 |
To evaluate diagnostic accuracy of PSMA-PET/CT and FACBC-PET/CT in detection of lymph node metastases in initial staging of intermediate- to high-risk PCa |
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E.2.2 | Secondary objectives of the trial |
Secondary study parameters are (a) diagnostic performance of 18F-PSMA-1007 PET/CT
and anti-3-[18F] FACBC PET/CT in detection of distant metastases, (b) diagnostic performance of 18FPSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in staging of the primary tumor in the prostate
specimen, (c) detection rate of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT as a
function of PSA level, nomogram risk and size of suspected lymph nodes, (d) change of management
induced by 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT and (e) cost-associated with
18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT as diagnostic modality additional to the
regular diagnostic work-up versus pelvic lymph node dissection. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Biopsy proven adenocarcinoma of the prostate;
2. Indication for (super)extended PLND (with or without (robot-assisted) laparoscopic prostatectomy), in intermediate and high risk patients ( d’Ámico score) with an MSKCC >5% lymph node prediction;
3. Mentally competent and understanding of benefits and potential burden of the study;
4. Written informed consent;
5. Age ≥18 years. |
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E.4 | Principal exclusion criteria |
1. History of prior diagnosed or treated PCa.
2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin).
3. Unwillingness or inability to undergo 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT, in combination with PLND.
4. Metastasis beyond pelvic region and/or bone metastasis. Patients with bone metastasis will not get a PLND, but will be included in the study for further follow-up. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Patient and lesion-based diagnostic accuracy of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT (sensitivity, specificity, PPV and NPV) in detection of lymph node metastases |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After inclusion of 70 patients |
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E.5.2 | Secondary end point(s) |
a. Detection rate of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT for the detection of distant (bone) metastases.
b. Diagnostic accuracy of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in staging of the primary tumor in the radical prostatectomy specimen.
c. Diagnostic accuracy of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT for different risk groups (according to the d’Amico classification – see chapter 5.1.3), nomogram risk scores, and the size of malignant lymph nodes.
d. Diagnostic performance of 18F-PSMA-1007 PET/CT versus anti-3-[18F] FACBC PET/CT versus conventional imaging (MRI of the prostate) in detection of local tumor site and metastases.
e. Change of management induced by 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT findings specifically.
f. Cost-effectiveness of 18F-PSMA-1007 PET/CT versus anti-3-[18F] FACBC PET/CT for the detection of (regional) LNMs. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After inclusion of 70 patients |
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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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Extended pelvic lymphnode dissection |
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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
| 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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |