Comparison of two methods for the identifacation of lymph node metastases in patients with locally advanced prostate cancer

68Ga-PSMA PET/CT vs. MRI/CT vs. lymphadenectomy for the identification of lymph node metastases in locally advanced prostate cancer patients: a diagnostic test accuracy study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004210-28-DK

Enrollment

Unknown

Registered

2014-12-12

Start date

2015-01-29

Completion date

Unknown

Last updated

2017-03-13

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

Conditions

Patients diagnosed with advanced prostate cancer that are scheduled for lymph node staging. MedDRA version: 18.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: LLT

Interventions

Product Name: 68Ga-PSMA-HBED-CC Product Code: 68Ga-PSMA Pharmaceutical Form: Solution for injection INN or Proposed INN: 68Ga-PSMA-HBED-CC Other descriptive name: • 68Ga-‘2-[3-(1-Carboxy-5-{6-[3-(3-{[

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Oral and written informed consent. 18 years and older. Histological confirmed adenocarcinoma of the prostate. Routine bone scintigraphy without metastasis. Referred for lymph node staging as standard clinical practice - either concurrent with surgical removal of the prostate (radical prostatectomy) or prior to curative (radiation therapy) or palliative (hormonal) treatment. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Prior or current therapy for prostate cancer. History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer. History of allergic reactions attributed to compounds of 68Ga-PSMA radiotracer. Subjects unable to undergo 68Ga PSMA PET/CT imaging procedure (e.g. claustrophobia despite oral anxiolytics). Subjects weighing greater than 180 kilograms (weight limit for scanner table), or unable to fit within the imaging gantry. Subjects with any medical condition or other circumstances (e.g. claustrophobia, unable to lie still, unable to comply with study procedures etc.) that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study. If the patient refuses MRI or is not eligible (known with e.g. claustrophobia or other reasons as outlined in the ESUR guideline for MRI), the patient will be offered a diagnostic CT in combination with 68Ga-PSMA PET. If the patient refuses a diagnostic CT scan or allergic or ineligible for such procedure only a 68Ga-PSMA PET/low dose CT will be performed. Such patients will be assessed for secondary endpoints only.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the sensitivity and specificity of 68Ga-PSMA PET/CT versus MRI/CT against the reference test (lymphadenectomy) for the detection of lymph node metastasis on a patient-level in patients with locally advanced PCa.;Secondary Objective: To investigate the sensitivity and specificity of 68Ga-PSMA PET/CT versus MRI/CT against the reference test (lymphadenectomy) for the detection of lymph node metastasis on a lesional (node-region) level. To investigate observer agreement in the assessment of 68Ga-PSMA PET/CT for local prostate involvement, nodal spread and bone metastasis if present. To assess the presence, if any, of bone metastasis in the axial skeleton as demonstrated by 68Ga-PSMA PET/CT and DW-MRI in patients with a metastasis-free bone scintigraphy performed as part of the standard staging procedure.;Primary end point(s): A sensitivity of at least 90% of the 68Ga-PSMA PET/CT.;Timepoint(s) of evaluation of this end point: Evaluation of end points will be done after 70 patients have accomplished this study.	—

Measure

Time frame

Main Objective: To investigate the sensitivity and specificity of 68Ga-PSMA PET/CT versus MRI/CT against the reference test (lymphadenectomy) for the detection of lymph node metastasis on a patient-level in patients with locally advanced PCa.;Secondary Objective: To investigate the sensitivity and specificity of 68Ga-PSMA PET/CT versus MRI/CT against the reference test (lymphadenectomy) for the detection of lymph node metastasis on a lesional (node-region) level. To investigate observer agreement in the assessment of 68Ga-PSMA PET/CT for local prostate involvement, nodal spread and bone metastasis if present. To assess the presence, if any, of bone metastasis in the axial skeleton as demonstrated by 68Ga-PSMA PET/CT and DW-MRI in patients with a metastasis-free bone scintigraphy performed as part of the standard staging procedure.;Primary end point(s): A sensitivity of at least 90% of the 68Ga-PSMA PET/CT.;Timepoint(s) of evaluation of this end point: Evaluation of end points will be done after 70 patients have accomplished this study.

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Secondary

Measure	Time frame
Secondary end point(s): To evaluate observer agreement when 68Ga-PSMA is used for detection of local prostate cancer, lymph node and bone metastases. To assess if 68Ga-PSMA PET/CT and diffusion weighted MRI can detect bone metastases not identified in standard staging procedure.;Timepoint(s) of evaluation of this end point: Evaluation of end points will be done after 70 patients have accomplished this study.	—

Measure

Time frame

Secondary end point(s): To evaluate observer agreement when 68Ga-PSMA is used for detection of local prostate cancer, lymph node and bone metastases. To assess if 68Ga-PSMA PET/CT and diffusion weighted MRI can detect bone metastases not identified in standard staging procedure.;Timepoint(s) of evaluation of this end point: Evaluation of end points will be done after 70 patients have accomplished this study.

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Countries

Denmark

Contacts

Public ContactLars Jelstrup Petersen

Department of Nuclear Medicine, Aalborg University Hospital

lajp@rn.dk+4597665484

Outcome results

None listed

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