Clinical trial NCT04239742: F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer
Official title: F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer, Comparison With 18F-Fluciclovine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer Recurrent
Keywords: 18F-PSMA-1007
18F-Fluciclovine
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ABX advanced biochemical compounds GmbH
name: Radboud Translational Medicine
First posted: 2020-01-27
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: every individual gets two diagnostic PET CT scans within 2 weeks apart.
Primary purpose: DIAGNOSTIC

Brief summary: 18F-PSMA-1007 is a new radiopharmaceutical for the detection of prostate cancer with potential benefits over the registered 18F-Fluciclovine (Axumin). The main potential benefit is the higher detection rate of PSMA compared to Fluciclovin in the low PSA range. It may therefore be more sensitive in detecting local disease in case of biochemical recurrens. The investigators aim to compare the detection efficacy of 18F-PSMA-1007 to 18F-Fluciclovin in prostate cancer patients with biochemical recurrence (PSA levels 0.2-5 ng/ml).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection efficacy of the two PET-tracers on a per patient level
timeFrame: Follow-up duration is 6 months.
measure: Detection efficacy of the two PET-tracers on a per lesion level
timeFrame: Follow-up duration is 6 months.
Secondary outcomes:
measure: Quantitative analysis
timeFrame: 6 months
measure: Comparing specificity
timeFrame: 6 months
measure: Sensitivity per area, local recurrence
timeFrame: 6 months
measure: Sensitivity per area, locoregional lymph nodes
timeFrame: 6 months
measure: Sensitivity per area, distant lymph nodes
timeFrame: 6 months
measure: Sensitivity per area, bone metastases
timeFrame: 6 months
measure: Sensitivity per area, extraskeletal organ metastases, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.
timeFrame: 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: James Nagarajah, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: