None listed
Conditions
Brief summary
Prostate cancer is the most commonly diagnosed cancer in Australian men. PSMA PET-CT (“prostate specific membrane antigen positron emission tomography computed tomography”), or “PSMA PET” for short, is increasingly being used for the imaging of prostate cancer. For this imaging technique, PSMA (prostate specific membrane antigen) is bound to a small amount of a radioactive imaging tracer. Two different imaging tracers are available in Western Australia, based on Gallium 68 (Ga 68) and Fluorine 18 (F18) compounds. This purpose of this study is to: • Evaluate the consistency of PSMA PET scans when the same type of scan is repeated within a short time frame (approximately one week). • Compare results of a Ga68-PSMA PET scan with results from a F18-PSMA PET scan, when both are performed within a short time frame (approximately one week apart). Who is it for? You may be eligible for this study if you are a male aged 18 or older and have been diagnosed with metastatic prostate cancer, you have not had a change in your cancer treatment in the last 12 weeks and have been referred by your treating physician to have a PSMA PET scan. Study details All participants in this study will have one additional PSMA PET within 2 weeks of the first scan. You will be allocated to receive either two Ga68-PSMA PET scans, two F18-PSMA PET scans or one scan with each radiotracer (ie: one Ga68 PSMA PET and one F18 PSMA PET scan). At each scan you will have one of the radioactive tracing agents injected into your arm, followed by a 1-2 hour wait before the scan is performed. You will then be positioned on the bed of the scanner to get PET and CT pictures of your body from head to thighs. The time in the scanner is around 20 minutes. In total, participation in the study will involve one additional visit to hospital in order to have a second PSMA PET. The time required for this visit will be 2 – 3 hours after which time you can return home without further assessments.
Interventions
Participants in this study will receive one additional Prostate Specific Membrane Antigen (PSMA) PET scan above normal standard of care within 2 weeks of the initial scan. Participants will be allocated to receive either two Gallium 68 (Ga 68)-PSMA PET scans, two Fluorine 18 (F18)-PSMA PET scans or one scan with each radiotracer (ie: one Ga68 PSMA PET and one F18 PSMA PET scan). In total, study participation will involve one additional visit to hospital in order to have a second PSMA PET scan. T
Participants in this study will receive one additional Prostate Specific Membrane Antigen (PSMA) PET scan above normal standard of care within 2 weeks of the initial scan. Participants will be allocated to receive either two Gallium 68 (Ga 68)-PSMA PET scans, two Fluorine 18 (F18)-PSMA PET scans or one scan with each radiotracer (ie: one Ga68 PSMA PET and one F18 PSMA PET scan). In total, study participation will involve one additional visit to hospital in order to have a second PSMA PET scan. The time required for this visit will be 2 – 3 hours. The additional PET scan is for research only and will not be used to change prostate cancer treatment. Scan attendance will be monitored and recorded by study data management personnel. Each PSMA PET scan includes the following procedures which are performed in a single visit: - A needle is inserted into a hand or arm vein by a Nuclear Medicine Nurse or Technologist and a small amount of the radioactive PSMA is injected (1.7 MBq/kg Ga68 PSMA or 4 MBq/kg F18 PSMA). - This is followed by a wait of 1-2 hours. During this time, the PSMA travels through the blood stream and is taken up by prostate cancer cells. It has a small amount of radioactivity which is detected by the scanner. -Participants are then positioned on the bed of the scanner to get PET and CT pictures of body the from head to thighs. The total time in the scanner is around 20 minutes.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Metastatic prostate cancer with evidence of PSA progression • No change in prostate cancer specific treatment in the previous 12 weeks. • Males greater than 18 years old. • Able to provide informed consent and undergo study procedures.
Exclusion criteria
• Unable to provide informed consent. • Other active neoplastic disease
Outcome results
None listed