A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer (NCT05712174) | Clinical Trial Compass
TerminatedPhase 2
A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer
Stopped: Accrual to the biochemically recurrent and metastatic cohorts complete; however, accrual to the remaining two cohorts was lagging and deemed no longer feasible.
Canada176 participantsStarted 2023-09-14
Plain-language summary
A \[18\]F-PSMA-1007 PET/CT or PET/MRI scan are nuclear medicine tests used to create pictures of the whole body that may show where cells that express Prostate-Specific Membrane Antigen (PSMA) are found. PSMA is a transmembrane protein that is overexpressed in the majority of prostate cancers. PSMA imaging utilizes this overexpression, by binding on the transmembrane receptor and internalization in the cancer cells. The internalized isotope can then be imaged with the use of a PET/CT or PET/MRI scanner and show where cancer cells may be present in the body. This imaging modality has been shown to be superior to conventional imaging, such as bone scan and CT, in the detection of prostate cancer tumors.
The purpose of this study is to: 1) assess the clinical impact of a \[18\]F-PSMA-1007 scan on patient management plans; 2) assess the diagnostic effectiveness of a \[18\]F-PSMA-1007 scan in participants with known or suspected metastatic prostate cancer, as compared to standard of care CT chest, abdomen, pelvis and bone scan; 3) evaluate the safety of \[18\]F-PSMA-1007; and 4) assess potential correlations of PSMA level of uptake in certain tumors with cancer biologic markers such as PSA and Gleason score.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Confirmed prostate cancer by histopathology or cytology;
✓. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 within two weeks of enrollment;
✓. Males at least 18 years of age;
✓. Any of the following clinical criteria:
✓. 99m-Technecium bone scan and CT of the chest abdomen and pelvis, within 4 weeks of study enrollment.
✓. Receipt of a complete \[18\]F-PSMA-1007 PET/CT or PET/MRI referral package, including baseline history information and treatment intent from the referring physician, prior to enrolment.
✓. Able and willing to follow instructions and comply with the protocol;
✓. Ability to provide written informed consent prior to participation in the study.
Exclusion criteria
✕. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);
What they're measuring
1
Questionnaire based assessment of the impact of [18]F-PSMA-1007 PET/CT or PET/MRI on patient management plans
Timeframe: Prior to and within 30 days following [18]F-PSMA-1007 PET/CT or PET/MRI
. Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
✕. Weight exceeding the PET/CT or PET/MRI scanner limit;
✕. Known allergic reaction to \[18\]F-PSMA-1007;
✕. Patients who have initiated new therapy (ADT, systemic therapy, or radiation) for their prostate cancer within 4 weeks of enrollment in those with high-tier intermediate risk or high risk localized prostate cancer, or biochemically recurrent prostate cancer post-prostatectomy or definitive radiotherapy.