Dosimetry and Safety Phase 1 Study With 68Ga-PSMA-11 Sterile Cold Kit (PSMA)
Primary Purpose
Prostatic Neoplasm
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasm
Eligibility Criteria
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
Sites / Locations
- Cliniques Universitaires Saint-Luc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit
Arm Description
Single injection for diagnostic use only
Outcomes
Primary Outcome Measures
Maximum Plasma concentration
Measures based on blood tests
Maximum Urine concentration
Based on urine samples
Secondary Outcome Measures
Time dependant changes of the injected activity per organ
Calculation of mean organ-absorbed doses and effective doses
Incidence of treatment emergent adverse events
Vital signs, laboratory parameters and adverse reactions
Full Information
NCT ID
NCT03183544
First Posted
June 1, 2017
Last Updated
October 23, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03183544
Brief Title
Dosimetry and Safety Phase 1 Study With 68Ga-PSMA-11 Sterile Cold Kit
Acronym
PSMA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
February 24, 2020 (Actual)
Study Completion Date
February 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
5 patients with limited recurrent prostate cancer and 3 healthy volunteers will be enrolled in this clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit
Arm Type
Experimental
Arm Description
Single injection for diagnostic use only
Intervention Type
Combination Product
Intervention Name(s)
Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit
Intervention Description
The patients will receive a single injection of Gallium-68 PSMA-11 to diagnose biochemical relapse of prostate cancer after treatment.
Primary Outcome Measure Information:
Title
Maximum Plasma concentration
Description
Measures based on blood tests
Time Frame
at day 0
Title
Maximum Urine concentration
Description
Based on urine samples
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Time dependant changes of the injected activity per organ
Description
Calculation of mean organ-absorbed doses and effective doses
Time Frame
at day 0
Title
Incidence of treatment emergent adverse events
Description
Vital signs, laboratory parameters and adverse reactions
Time Frame
Up to 6 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
This protocol concerns only patients with prostatic cancer and male healthy volunteers.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Jamar, MD, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD at this moment
Learn more about this trial
Dosimetry and Safety Phase 1 Study With 68Ga-PSMA-11 Sterile Cold Kit
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