None listed
Conditions
Brief summary
This study will investigate the use of Gallium 68 Prostate Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans in the treatment of metastatic prostate cancer. Who is it for? You may be eligible to join this study if you are Male, aged 18 years or above, have a pathologically confirmed adenocarcinoma of the prostate that has metastasised. Study details There are two cohorts under investigation: one group who have castrate sensitive metastatic prostate cancer commencing androgen deprivation therapy for clinical reasons while the other has castrate resistant metastatic prostate cancer, who are commencing androgen blockage therapy (Abiraterone or Enzalutamide) for clinical reasons. Participants will receive a GaPSMA PET scan, free of charge. If the GaPSMA PET scan detects any cancer, the participant will continue with study. If the GaPSMA PET scan does not detect any cancer, then the participant is withdrawn from the study. Irrespective of whether or not the GaPSMA PET scan detects any cancer, the participant will receive clinical treatment as indicated. The eligible participant will return for follow-up PSMA PET scans at days 9, 18 and 28. The participant will continue with ADT as clinically required. Clinical information and imaging results will be collected at these times points (baseline, Days 9, 18 and 28). The findings of the study will enable clinicians to better plan for the treatment of metastatic prostate cancer, particularly with the use of treatment that target PSMA cancer sites.
Interventions
The treating medical oncologist will firstly review that potential participant for eligibility to participate in the study. The participant will then be asked to participant in the study and if the participant consents to the study, the participant will receive a GaPSMA PET scan, free of charge.
A GaPSMA PET scan will involve a needle inserted into the arm and the participant will be injected with a small volume of 68Ga-PSMA, the imaging agent. The participant will be placed under the PET scan
The treating medical oncologist will firstly review that potential participant for eligibility to participate in the study. The participant will then be asked to participant in the study and if the participant consents to the study, the participant will receive a GaPSMA PET scan, free of charge. A GaPSMA PET scan will involve a needle inserted into the arm and the participant will be injected with a small volume of 68Ga-PSMA, the imaging agent. The participant will be placed under the PET scanner, and some pictures will be taken of the whole body about 45 minutes after injection. The scan will take 30 minutes. If the GaPSMA PET scan detects any cancer, the participant will continue with study. If the GaPSMA PET scan does not detect any cancer, then the participant is withdrawn from the study. Irrespective of whether or not the GaPSMA PET scan detects any cancer, the participant will receive clinical treatment as indicated. The eligible participant will return to have PSMA PET scans at days 9, 18 and 28. The participant will continue with either ADT or androgen blockade treatment as clinically required. Clinical information and imaging results will be collected at these times points (baseline, Days 9, 18 and 28). The GaPSMA PET scan will occur at St Vincent’s Hospital Sydney.
Sponsors
St Vincent's Hospital, Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants meeting all of these criteria are eligible for the study: 1. Castrate sensitive metastatic prostate cancer commencing androgen deprivation 2. Male, aged 18 years or older 3. Pathologically confirmed adenocarcinoma of prostate 4. Metastatic prostate cancer (> 4 extra-prostatic lesions) confirmed on imaging (sites of disease not relevant) 5. Gleason score 7-10 6. GaPSMA positive disease on screening PET CT 7. Provision of written informed consent. OR 1. Castrate resistant metastatic prostate cancer, who are commencing androgen blockage therapy (Abiraterone or Enzalutamide) 2. Male, aged 18 years or older 3. Pathologically confirmed adenocarcinoma of prostate 4. Metastatic prostate cancer (> 4 extra-prostatic lesions) confirmed on imaging (sites of disease not relevant) 5. Gleason score 7-10 6. GaPSMA positive disease on screening PET CT 7. Provision of written informed consent.
Exclusion criteria
1. Prostate cancer that is not metastatic 2. Prostate cancer that is not measurable on GaPSMA PET CT (5% of all prostate cancers) 3. Patients who refuse to join the trial or are unable to consent. 4. Patients who cannot lie still for at least 30 minutes or comply with imaging.
Outcome results
None listed