Clinical Trial · NCT03183544

Dosimetry and Safety Phase 1 Study With 68Ga-PSMA-11 Sterile Cold Kit

Overview

Prostate cancer is the most common cancer in men. Early detection of primary diseases and recurrence is crucial for patient counseling and management. Conventional imaging modalities (CT-MRI) are limited to detect recurrence. Choline-based PET/CT is currently widely used as primary staging tool in prostate cancer and in patients with suspicious recurrent disease. Compared to choline-based tracers, 68Ga-PSMA ligands have been shown to have a higher diagnostic efficacy and to increase the detection of metastases even at low PSA levels. The most widely used prostate-specific membrane antigen (PSMA) ligand is PSMA-11. A supplier, ANMI, has developed a kit formulation of PSMA-11 which will be test in this clinical trial.

Sponsor

Unknown Organization

Phase

Phase 1

Contacts

François Jamar, MD, PhD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03183544

Eligibility

Inclusion

Radical therapy by surgery or radiotherapy
Ability to undergo a two-day experimental study within a time interval of 7-15 days and the appropriate follow-up.
Normal bone marrow function (hemoglobin \[Hb\]\>12g/dl, white blood cells \[WBC\]\>4500/µl, platelets\>140,000/µl)
No known prostate disease according to medical history, current symptoms and digital rectal examination
Negative or inconclusive findings with standard imaging techniques as assessed by the referring physician with e.g. thoraco-abdominal Computed Tomography \[CT\] scan, bone scan or Magnetic Resonance Imaging \[MRI\] within the previous two months before inclusion
Normal renal function (MDRD glomerular filtration rate \>60/ml/min/1.73m2)
Normal liver function (bilirubin, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and gamma glutamyltransferase \[GGT\] \<2x upper limit of normal \[ULN\]
Male gender
For all individuals
PSA level \<3ng/ml
Prostate specific antigen \[PSA\] level between 0.5 and 2ng/ml confirmed within two weeks before inclusion
Ability to undergo a one-day experimental study and the appropriate follow-up For healthy volunteers

Exclusion

Medical or psychiatric condition that would preclude the conduct of the study to its end
History of surgery or radiotherapy of the salivary gland or neck
History of salivary gland disease (except recovered childhood mumps)
Chronic renal disease (except nephroangiosclerosis or early diabetic nephropathy) even if renal function is normal
For all individuals
Urinary incontinence
Concomitant malignant disease or diagnosis of cancer within five years prior to enrollment (except basal cell carcinoma)
Pregnant partner