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

Phase 1

• Conditions: Patients diagnosed with advanced prostate cancer that are scheduled for lymph node staging.; MedDRA version: 18.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: LLTClassification code 10036223Term: Positron emission tomographySystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004210-28-DK
• Lead Sponsor: Department of Nuclear Medicine, Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-12
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified