E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with prostate cancer diagnosed by multiparametric-MRI and systematic and targeted biopsies; intermediate- and high-risk prostate cancer; eligible for a radical prostectomy and extended lymph node dissection.
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E.1.1.1 | Medical condition in easily understood language |
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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 | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036223 |
E.1.2 | Term | Positron emission tomography |
E.1.2 | System Organ Class | 100000004848 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
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 |
Evaluate the precision of [18F]-JK-PSMA-7 PET/CT for detection of lymph node metastases during pre-therapy evaluation and to compare the precision with that of conventional imaging. |
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E.2.2 | Secondary objectives of the trial |
Evaluate the precision of [18F]-JK-PSMA-7 PET/CT for intra prostatic tumour detection Evaluate impact of [18F]-JK-PSMA-7 PET/CT on the recurrence free survival. Evaluation of the usefulness of a second [18F]-JK-PSMA-7 PET/CT performed one month after radical prostectomy and extended lymph node dissection. In case of recurrence, this second PET-CT will help in decision taking for new surgery or complementary radiotherapy. Evaluate the potential impact of [18F]-JK-PSMA-7 PET/CT on therapeutic decisions
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
o Patients with prostate cancer diagnosed by multiparametric-MRI and systematic and targeted biopsies o intermediate- and high-risk prostate cancer in agreement with the European Recommendations 2019 o patients eligible for a radical prostectomy and extended lymph node dissection o patients ≥ 18 years old o Signed Informed Consent.
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E.4 | Principal exclusion criteria |
o Patients that already received treatment for prostate cancer. o Patients non-eligible for surgery o Non-compliant patients o Subject suffers from claustrophobia or cannot tolerate confinement during PET/CT scanning procedures o Subject does not understand the study procedure. o Subject has recently (< 30 days) participated or is simultaneously participating in another prospective interventional clinical trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
The anatomical localization of suspect lymph nodes identified by [18F]-JK-PSMA-7 pre-biopsy PET will be compared to those identified by pre-biopsy abdomino-pelvic MRI and histological examination using the extended lymph node resection template. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after second PET/CT scan (post surgery) |
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E.5.2 | Secondary end point(s) |
1.[18F]-JK-PSMA-7 pre-surgical PET images of the suspected lesion will be compared to [18F]-JK-PSMA-7 post-surgical PET images. 2.In case of biochemical recurrence or persistence of elevated PSA post-surgery, a third [18F]-JK-PSMA-7 PET/CT will be acquired. In case of absence of distant recurrence detected on the PET/CT, the patient will be treated with pelvic (prostate bed and lymph node areas) radiotherapy associated with short term hormonal therapy. In case of oligo-metastatic disease (≤3 metastatic lesions), metastases will be treated by radiotherapy or additional surgery. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.one month after surgery 2. in case of biochemical recurrence |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |