Prostatic NeoplasmPhase 1PSMANCT03183544
Dosimetry and Safety Phase 1 Study With 68Ga-PSMA-11 Sterile Cold Kit
A Phase 1 study testing Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit in people with Prostatic Neoplasm, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Jan 2019to 24 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- ≥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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Prostatic Neoplasm
- Being tested
- Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold KitCombination product
The patients will receive a single injection of Gallium-68 PSMA-11 to diagnose biochemical relapse of prostate cancer after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit | Experimental | Single injection for diagnostic use only Receives: Combination Product: Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma concentration
Measures based on blood tests
Measured: at day 0
Maximum Urine concentration
Based on urine samples
Measured: Up to 6 months
Secondary outcomes (2)
Time dependant changes of the injected activity per organ
Calculation of mean organ-absorbed doses and effective doses
Measured: at day 0
Incidence of treatment emergent adverse events
Vital signs, laboratory parameters and adverse reactions
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start24 Jan 2019
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 5 patients with limited recurrent prostate cancer and 3 healthy volunteers will be enrolled in this clinical trial
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Jamar, MD, PhD, Study director, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183544
- Sponsor's protocol ID
- 2017/30MAI/305
- Acronym
- PSMA
- Status last verified
- Oct 2020
- First submitted
- 1 Jun 2017
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD at this moment
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03183544
- Acronym / sponsor ID
- PSMA / 2017/30MAI/305
- Conditions
- Prostatic Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 5 patients with limited recurrent prostate cancer and 3 healthy volunteers will be enrolled in this clinical trial
| Arm | Type | Receives |
|---|---|---|
| Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit | Experimental | Combination Product: Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold KitSingle injection for diagnostic use only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- For all individuals
Key exclusion criteria (8 listed)
- For all individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold KitThe patients will receive a single injection of Gallium-68 PSMA-11 to diagnose biochemical relapse of prostate cancer after treatment. | Combination product | Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit |
Primary outcome
Maximum Plasma concentration
Time frame: at day 0
Measures based on blood tests
Maximum Urine concentration
Time frame: Up to 6 months
Based on urine samples
2 secondary outcomes
Time dependant changes of the injected activity per organ
Time frame: at day 0
Incidence of treatment emergent adverse events
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: No. There is no plan to share IPD at this moment
Related trials for Prostatic Neoplasm
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A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
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RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Jamar, MD, PhD study director
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit in people with Prostatic Neoplasm, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma concentration (time frame: at day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.