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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasm
• Intervention / Treatment: Combination product: Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit; Single injection for diagnostic use only	Combination product: Gallium-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma concentration	Measures based on blood tests	at day 0
Maximum Urine concentration	Based on urine samples	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time dependant changes of the injected activity per organ	Calculation of mean organ-absorbed doses and effective doses	at day 0
Incidence of treatment emergent adverse events	Vital signs, laboratory parameters and adverse reactions	Up to 6 months

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Study Director: François Jamar, MD, PhD, Cliniques Universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): February 24, 2020
• Study Completion (Actual): February 24, 2020

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: 2017/30MAI/305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share IPD at this moment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No