- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03558711
PSMA-PET/CT for Prostate Cancer (NGP1)
Prostate cancer is the most frequently occurring male cancer in Belgium. Patients who have been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker PSA (prostate specific antigen) within the first few years. In these patients with evidence of a tumor recurrence after primary treatment, it is important to most exactly define the location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or hormonotherapy. In so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. Therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated.
With some patients, the PSA-value is so low, that conventional nuclear medicine bone scanning or radiological CT or MRI cannot determine where the metastases are. Therefore, [18F]-Choline PET-CT was introduced to improve diagnostic imaging performance. However, in 30 to 40 percent of patients choline-PET does not localize tumor either, especially in small tumors and/or very low PSA values.
The PSMA PET is already routinely used in many European centres, and has shown a superior accuracy in these patients as compared to conventional imaging techniques. This has been a very consistent finding in scientifically reported patient studies.
Most of these investigations have been performed with PSMA labeled with Gallium-68. The investigators in Ghent, as others, have labeled PSMA with Fluor-18. This tracer provides many advantages, including a higher production yield enabling more patients to be scanned. Also from a perspective of radioprotection and financial costs, Fluor-18 is a better choice. Moreover, several recent studies, comparing Fluor with Gallium modalities seem to suggest equivalent or better diagnostic results, possibly because of a lower aspecific background activity.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Gent, Belgium
- University Hospital, Ghent
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after curative treatment (prostatectomy with or without lymphadenectomy or radiotherapy), or at primary diagnosis and staging.
Exclusion Criteria:
- Age < 40 or > 70 years in phase-1; upper age limit is not applicable for the phase-2 trial.
Most patients will be > 65 years old, an estimate may be more than 80%.
- Physically or mentally unfit to perform the sequential procedures
- Refusal of patient to be informed about accidental findings on scans.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: study group
|
18F-PET imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of administration - follow up of adverse events
Time Frame: Adverse events are followed up until 24 hours after PSMA administration.
|
Follow up of treatment-related adverse events according to CTCAE v4.0 criteria.
|
Adverse events are followed up until 24 hours after PSMA administration.
|
Safety of administration - change in blood pressure
Time Frame: hourly checking of blood pressure from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
|
Changes in blood pressure (systolic and diastolic, expressed in mm Hg)
|
hourly checking of blood pressure from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
|
Safety of administration - change in temperature
Time Frame: hourly checking of temperature from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
|
Changes in temperature (expressed in °C)
|
hourly checking of temperature from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
|
Safety of administration - change in heart rate
Time Frame: hourly checking of heart rate from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
|
Changes in heart rate (expressed in beats per min)
|
hourly checking of heart rate from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
|
Safety of administration - erythrocytes
Time Frame: before and 300 minutes after 18F-PSMA administration
|
Changes in erythrocytes count in plasma (expressed in 10^6/µL)
|
before and 300 minutes after 18F-PSMA administration
|
Safety of administration - haemoglobin
Time Frame: before and 300 minutes after 18F-PSMA administration
|
Changes in haemoglobin concentration in plasma (expressed in g/dL)
|
before and 300 minutes after 18F-PSMA administration
|
Safety of administration - leukocytes
Time Frame: before and 300 minutes after 18F-PSMA administration
|
Changes in leukocytes count in plasma (expressed in 10^3/µL)
|
before and 300 minutes after 18F-PSMA administration
|
Safety of administration - thrombocytes
Time Frame: before and 300 minutes after 18F-PSMA administration
|
Changes in thrombocytes count in plasma (expressed in 10^3/µL)
|
before and 300 minutes after 18F-PSMA administration
|
Safety of administration - sodium
Time Frame: before and 300 minutes after 18F-PSMA administration
|
Changes in sodium concentration in serum(expressed in mmol/L)
|
before and 300 minutes after 18F-PSMA administration
|
Safety of administration - creatinine
Time Frame: before and 300 minutes after 18F-PSMA administration
|
Changes in creatinine concentration in serum (expressed in mg/dL)
|
before and 300 minutes after 18F-PSMA administration
|
Safety of administration - AST
Time Frame: before and 300 minutes after 18F-PSMA administration
|
Changes in AST concentration in serum (expressed in U/L)
|
before and 300 minutes after 18F-PSMA administration
|
Safety of administration - ALT
Time Frame: before and 300 minutes after 18F-PSMA administration
|
Changes in ALT concentration in serum (expressed in U/L)
|
before and 300 minutes after 18F-PSMA administration
|
Safety of administration - Alkaline phosphatase
Time Frame: before and 300 minutes after 18F-PSMA administration
|
Changes in alkaline phosphatase concentration in serum (expressed in U/L)
|
before and 300 minutes after 18F-PSMA administration
|
Biodistribution of 18F-PSMA
Time Frame: 0 to 300 minutes after 18F-PSMA administration
|
Follow up of 18F-PSMA distribution over time in blood, urine, and organs.
18F-PSMA
|
0 to 300 minutes after 18F-PSMA administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establishment of critical organs
Time Frame: 0 to 300 minutes after 18F-PSMA administration
|
Based on the biodistribution of 18F-PSMA (primary outcome 14), it will be investigated which organs receive the highest radiation dose (expressed in mGy/MBq).
|
0 to 300 minutes after 18F-PSMA administration
|
Investigation of the stability of 18F-PSMA over time in plasma
Time Frame: 0 to 300 minutes after 18F-PSMA administration
|
The stability of 18F-PSMA will be assessed via measurement of the percentage defluorination of the compound.
Free 18F will be separated from 18F-PSMA using solid-phase extraction, radioactivity (kBq/cc) of each fraction will be measured.
|
0 to 300 minutes after 18F-PSMA administration
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGO/2017/006
- 2017-003461-96 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on 18F-PSMA
-
University of AlbertaActive, not recruiting
-
Alessandro D'AgnoloProgenics Pharmaceuticals, Inc.Active, not recruitingNeoplasms | Urogenital Neoplasms | Neoplasms by Site | Genital Neoplasms, Male | Prostatic Neoplasms | Genital Diseases, Male | Prostatic DiseaseUnited States
-
University Hospital, GhentCompleted
-
Primo Biotechnology Co., LtdABX advanced biochemical compounds GmbHRecruitingProstate Cancer | Prostate NeoplasmTaiwan
-
University of Wisconsin, MadisonTerminated
-
Irene BurgerCompletedProstate CancerSwitzerland
-
IRCCS San RaffaeleNot yet recruiting
-
University of AlbertaRecruiting
-
University Hospital Inselspital, BerneActive, not recruiting
-
Wuerzburg University HospitalRecruitingGastrointestinal CancerGermany