Diagnostic Performance of prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) imaging for Pre-operative lymph Node assessment in intermediate and high-risk prostate cancer.

Diagnostic Performance of prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) imaging for Pre-operative lymph Node assessment in intermediate and high-risk prostate cancer. - PREOP-PSMA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003323-42-FR

Enrollment

150

Registered

2020-11-30

Start date

2021-03-01

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer MedDRA version: 21.0 Level: LLT Classification code 10036946 Term: Prostatic cancer System Organ Class: 100000004864

Interventions

Product Name: 68Ga-HBED-CC-PSMA Pharmaceutical Form: Injection

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Histologically confirmed prostate cancer; - Intermediate-risk prostate cancer (PSA level of 10- 20 ng/mL and/or Clinical tumor stage = T2b and/or ISUP 2 or 3, AND with risk of lymph node extension > 5% according to the Briganti nomogram) or high-risk prostate cancer (PSA = 20 ng/mL and/or TR = T2c and/or ISUP 4 or 5) according to d’Amico classification; - Curative treatment by radical prostatectomy chosen by the multidisciplinary consultation meeting. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110

Exclusion criteria

Exclusion criteria: - Refusal or inability to participate in the study ; - Low-risk prostate cancer according to D’Amico’s classification, or an intermediate-risk but with a risk of lymph node extension 2.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to determine the diagnostic performance of PSMA PET/CT for the detection of lymph node metastases in intermediate- and high-risk prostate cancer whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting.;Secondary Objective: - To assess the clinical impact of PSMA PET/CT in the surgical strategy of lymph node dissection, especially lymph node dissection extended to a resectable suspected area; - To compare MRI and PSMA PET/CT with histopathology; - To determine the diagnostic performance of PSMA PET/CT to detect distant metastases in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting; - To assess the value of PSMA PET/CT dynamic (versus static) acquisition to differentiate malignant lesions from benign lesions or physiological urinary elimination; - To confirm the 68Ga-HBED-CC-PSMA perfect tolerance.;Primary end point(s): Evaluate the sensitivity, specificity, and likelihood ratios of PET-PSMA for the detection of lymph node locations of intermediate- and high-risk prostatic neoplasia, in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting, with reference to the gold standard obtained from histology data and/or follow-up imaging. The gold standard will be obtained by extensive lymph node dissection performed on 6 lymph node areas (right and left obturators, right and left internal iliacs and right and left external iliacs) defined by the French Association of Urology and the European Association of Urology. The PET-PSMA scan diagnosis will focus on these same lymph node areas, returning a binary (positive or negative) result for each of them.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: The main objective of the trial is to determine the diagnostic performance of PSMA PET/CT for the detection of lymph node metastases in intermediate- and high-risk prostate cancer whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting.;Secondary Objective: - To assess the clinical impact of PSMA PET/CT in the surgical strategy of lymph node dissection, especially lymph node dissection extended to a resectable suspected area; - To compare MRI and PSMA PET/CT with histopathology; - To determine the diagnostic performance of PSMA PET/CT to detect distant metastases in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting; - To assess the value of PSMA PET/CT dynamic (versus static) acquisition to differentiate malignant lesions from benign lesions or physiological urinary elimination; - To confirm the 68Ga-HBED-CC-PSMA perfect tolerance.;Primary end point(s): Evaluate the sensitivity, specificity, and likelihood ratios of PET-PSMA for the detection of lymph node locations of intermediate- and high-risk prostatic neoplasia, in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting, with reference to the gold standard obtained from histology data and/or follow-up imaging. The gold standard will be obtained by extensive lymph node dissection performed on 6 lymph node areas (right and left obturators, right and left internal iliacs and right and left external iliacs) defined by the French Association of Urology and the European Association of Urology. The PET-PSMA scan diagnosis will focus on these same lymph node areas, returning a binary (positive or negative) result for each of them.;Timepoint(s) of evaluation of this end point: 12 months

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Secondary

Measure	Time frame
Secondary end point(s): - Modification of the surgical strategy of lymph node dissection based on PSMA PET/CT, compared to the strategy that would have been done by conventional imaging alone; - Pathological focal uptake detected on the 3 examinations (PSMA PET/CT and MRI vs. pathology = gold standard) for each of the 6 following prostate locations: base, middle, apex (right and left); - Sensitivity/specificity of PSMA PET/CT to detect distant metastases, using a composite standard of reference (combination of clinical data, histopathology, repeat PSA follow-up and any imaging findings obtained during usual follow-up, as available); - Early pelvic abnormal uptakes identified during dynamic acquisition, compared to images obtained 60 minutes after injection; - Parametric lesions uptakes, quantified by the PSMA uptake rate constant ki; - Adverse events collected during the assessment.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Secondary end point(s): - Modification of the surgical strategy of lymph node dissection based on PSMA PET/CT, compared to the strategy that would have been done by conventional imaging alone; - Pathological focal uptake detected on the 3 examinations (PSMA PET/CT and MRI vs. pathology = gold standard) for each of the 6 following prostate locations: base, middle, apex (right and left); - Sensitivity/specificity of PSMA PET/CT to detect distant metastases, using a composite standard of reference (combination of clinical data, histopathology, repeat PSA follow-up and any imaging findings obtained during usual follow-up, as available); - Early pelvic abnormal uptakes identified during dynamic acquisition, compared to images obtained 60 minutes after injection; - Parametric lesions uptakes, quantified by the PSMA uptake rate constant ki; - Adverse events collected during the assessment.;Timepoint(s) of evaluation of this end point: 12 months

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Countries

France

Contacts

Public ContactMenez

CHRU de Brest

tiphaine.menez@chu-brest.fr229020089+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026