Clinical trial · Interventional
Dosimetry and Safety Phase 1 Study With 68Ga-PSMA-11 Sterile Cold Kit
Kinetics, Biodistribution, Dosimetry and Safety Phase 1 Study With 68Ga-PSMA-11 Sterile Cold Kit, in Healthy Male Volunteers and Patients With Limited Recurrent Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit
- description
- Single injection for diagnostic use only
- interventionNames
- Combination Product: Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit
Primary outcomes (2)
- measure
- Maximum Plasma concentration
- timeFrame
- at day 0
- description
- Measures based on blood tests
- measure
- Maximum Urine concentration
- timeFrame
- Up to 6 months
- description
- Based on urine samples
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available