Prostatic Neoplasm
Conditions
Brief summary
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.
Detailed description
Prostate cancer represents the most common cancer in men and accounts for the third most common cancer death in men. Up to 50% of all patients undergoing radical prostatectomy or radiotherapy for primary treatment of prostate cancer develop biochemical recurrence. Early detection of primary diseases and recurrence is crucial for patient counseling and management. Conventional imaging modalities such as computed tomography (CT) or magnetic resonance imaging (MRI) are limited because they focus on morphologic information such as lymph node size and tissue structure. Positron emission tomography/computed tomography (PET/CT) is a hybrid imaging technique combining functional and morphological information. 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 can be labeled at room temperature by direct incubation of the kit with the gallium-68 eluted from a 68Ge/68Ga generator.
Interventions
COMBINATION_PRODUCTGallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit
The patients will receive a single injection of Gallium-68 PSMA-11 to diagnose biochemical relapse of prostate cancer after treatment.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
5 patients with limited recurrent prostate cancer and 3 healthy volunteers will be enrolled in this clinical trial
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* For all individuals * Male gender * 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 \[ULN\] * Normal bone marrow function (hemoglobin \[Hb\]\>12g/dl, white blood cells \[WBC\]\>4500/µl, platelets\>140,000/µl) * Informed consent For patients with limited recurrent prostate cancer * ≥18 years of age * Radical therapy by surgery or radiotherapy * Prostate specific antigen \[PSA\] level between 0.5 and 2ng/ml confirmed within two weeks before inclusion * 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 * Ability to undergo a one-day experimental study and the appropriate follow-up For healthy volunteers * 18 - 70 years of age * No known prostate disease according to medical history, current symptoms and digital rectal examination * PSA level \<3ng/ml * Ability to undergo a two-day experimental study within a time interval of 7-15 days and the appropriate follow-up.
Exclusion criteria
* For all individuals * Urinary incontinence * Chronic renal disease (except nephroangiosclerosis or early diabetic nephropathy) even if renal function is normal * Concomitant malignant disease or diagnosis of cancer within five years prior to enrollment (except basal cell carcinoma) * History of salivary gland disease (except recovered childhood mumps) * History of surgery or radiotherapy of the salivary gland or neck * Medical or psychiatric condition that would preclude the conduct of the study to its end * Pregnant partner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma concentration | at day 0 | Measures based on blood tests |
| Maximum Urine concentration | Up to 6 months | Based on urine samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time dependant changes of the injected activity per organ | at day 0 | Calculation of mean organ-absorbed doses and effective doses |
| Incidence of treatment emergent adverse events | Up to 6 months | Vital signs, laboratory parameters and adverse reactions |
Countries
Belgium
Outcome results
None listed