- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04239742
F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer (PROPER-ABX)
F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer, Comparison With 18F-Fluciclovine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rationale: 18F-PSMA-1007 is a new radiopharmaceutical for detection of prostate cancer with potential benefits over 18F-Fluciclovine, such as higher detection rates at low PSA levels and small lesions, lower bone marrow uptake and higher tumour-background ratio. Therefore, 18F-PSMA-1007 PET may be more sensitive in detecting local recurrence and metastases of prostate cancer. However, Fluciclovine is a registered tracer, whereas PSMA-1007 is not registered, and therefore there is pressure to use fluciclovine instead of PSMA-1007. Therefore more comparative data are urgently needed.
Objective: Main objective is to compare detection efficacy of 18F-PSMA-1007 PET-CT to 18F-Fluciclovine, in patients with early biochemical recurrence of prostate cancer.
Study design: Comparative phase II diagnostic study Study population: 50 males >18 years, with biochemical recurrence of prostate cancer and PSA-levels between 0.2-5.0 ng/mL. About 25 of the patients must have PSA-levels between 0.2-1.0 ng/mL. Contra-indications: claustrophobia, inability to lay still for the duration of the exam. Already established local recurrence in the prostate is not a contra-indication for study participation.
Intervention: 50 patients who already were referred by their treating physician for PET/CT will receive both an 18F-PSMA-1007 PET-CT (90 minutes post injection) and an 18F-Fluciclovine PET-CT (<15 minutes post injection). Injected dose of the 18F-PSMA-1007 will be 4 MBq/kg ±10%. The injected dose of 18F-Fluciclovine is 370 MBq ±10%.
Analysis: A clinical report is made of both the 18F-PSMA-1007 PET-CT scan and 18F-Fluciclovine PET-CT scan. For further analysis in the study all data will be anonymized, and will be blindly scored by two nuclear medicine physicians. The number of PET-positive lesions (judged to be prostate cancer, of course PET positive lesions referring to different processes like inflammation will not be taken intob account, this is oart of the PET-reading process) per area are separately scored for both tracers. Lesions will be scored on a 5-point scale ranging from most probably benign to most probably malignant. Follow-up data of the patients, to determine the eventual outcome, will be extracted from their medical file. An expert panel will eventually decide which lesions are considered to be metastases using all available follow-up data.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Willemijn van Gemert, MD, PhD
- Phone Number: 0031243614510
- Email: willemijn.vangemert@radboudumc.nl
Study Contact Backup
- Name: James Nagarajah, MD, PhD
- Phone Number: 0031243614510
- Email: James.nagarajah@radboudumc.nl
Study Locations
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-
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Nijmegen, Netherlands
- Recruiting
- Radboudumc
-
Contact:
- Willemijn van Gemert, MD, PhD
- Phone Number: 0243614510
- Email: willemijn.vangemert@radboudumc.nl
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males ≥ 18 years
- Histologically proven adenocarcinoma of the prostate
- Prior local treatment with curative intent
- Biochemical recurrence with (rising) PSA-levels of 0.2-5.0 ug/L
- Referred by urologist for PET/CT for localization of the recurrence
- PSA level determined <8 weeks before study participation
- Willing to sign informed consent
Exclusion Criteria:
- Contra-indications for PET-CT: claustrophobia or inability to lay still for the duration of the exam.
- Other cancer <2 years prior to biochemical recurrence of prostate cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 18F-PSMA PET/CT and 18F-Fluciclovin PET/CT
patients undergo an 18F-PSMA PET/CT scan and an 18F-Fluciclovin PET/CT scan, within a time frame of two weeks.
|
370 MBq ±10% 18F-Fluciclovin + low-dose CT scan, from skull base to pelvis.
Other Names:
4 MBq/kg ±10% F18-PSMA + low-dose CT scan, from skull base to pelvis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection efficacy of the two PET-tracers on a per patient level
Time Frame: Follow-up duration is 6 months.
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Comparisson of number of patients with a positive scan
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Follow-up duration is 6 months.
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Detection efficacy of the two PET-tracers on a per lesion level
Time Frame: Follow-up duration is 6 months.
|
Comparisson of number of positive lesions
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Follow-up duration is 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative analysis
Time Frame: 6 months
|
tumour background ratio, SUV (of tumor and normal organs)
|
6 months
|
Comparing specificity
Time Frame: 6 months
|
where the reference is consensus by the expert panel using all available information including 6 months follow up data (PSA-values; absolute and doublind time, pathology reports of suspected prostate cancer lesions, prostate-cancer targeted imaging by PET CT, MRI, CT or bone scan).
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6 months
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Sensitivity per area, local recurrence
Time Frame: 6 months
|
local recurrence, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.
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6 months
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Sensitivity per area, locoregional lymph nodes
Time Frame: 6 months
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locoregional lymph nodes, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.
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6 months
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Sensitivity per area, distant lymph nodes
Time Frame: 6 months
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Distant lymph nodes, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.
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6 months
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Sensitivity per area, bone metastases
Time Frame: 6 months
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Bone metastases, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.
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6 months
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Sensitivity per area, extraskeletal organ metastases, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.
Time Frame: 6 months
|
Extraskeletal organ metastases
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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: James Nagarajah, MD, PhD, Radboud University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL65593.091.18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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