Patients with prostate cancer diagnosed by multiparametric-MRI and systematic and targeted biopsies
Conditions
Interventions
Product Name: 18F-JK PSMA-7
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 18F JK-PSMA-11
Other descriptive name: 18F-JK-PSMA-11
Concentration unit: MBq/ml megabecquerel(s)/millilitr
Sponsors
CUB ULB Hôpital Erasme
Eligibility
Sex/Gender
Male
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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 ;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.;Timepoint(s) of evaluation of this end point: after second PET/CT scan (post surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: 1.one month after surgery 2. in case of biochemical recurrence | — |
Countries
Belgium
Contacts
Public ContactIrina
CUB ULB Erasme
Outcome results
None listed