Comparison of three methosd to identify prostate cancer relapse in patient who precviously have been through curative intended threapy

Phase 1

Conditions: Patients diagnosed with biochemical (PSA) relapse following curative intended treatment (defined as radical prostatectomy or radiotherapy, either by external beam radiotherapy or low- or high-dose brachytherapy, or any combination of these) will be included in this study.
MedDRA version: 17.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.1Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.1Level: LLTClassification code 10036223Term: Positron emission tomographySystem Organ Class: 100000004848
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-005073-37-DK

Lead Sponsor: Department of Nuclear Medicine, Aalborg University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

A subject is eligible for the study if all of the following apply:
Oral and written informed consent.
18 years and older.
The patient has undergone a curatively intended treatment for prostate cancer, which is considered to be radical at the end of the intervention/procedure.
Confirmed PCa recurrence (defined as PSA = 0.2 ng/ml or more after radical prostatectomy or a rise of 2.0 ng/ml above the post-treatment PSA-nadir following radiation therapy).
Subject is able to lie still for the duration of the imaging procedure.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer and prostate cancer.
History of allergic reactions attributed to compounds of 68Ga-PSMA radiotracer.
Subjects unable to undergo the PET/CT imaging procedure due to claustrophobia despite oral anxiolytics (institutional procedure).
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 (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.