None listed
Conditions
Brief summary
This study's purpose is to assess new bones lesion(s) in prostate cancer participants starting androgen deprivation therapy (ADT). Who is it for? You may be eligible to join this study if you have prostate cancer with a high risk of metastatic disease and your treating doctor recommends starting ADT and targeted radiotherapy. Study Details: Participants in this study will undergo a 68Ga-PSMA PET CT at study entry. Participants will have two additional 68Ga-PSMA PET CT at 6 and 12 months. Participants will be followed up per routine clinical care. Participants have the option of providing optional blood test. It is hoped that this research will provide insight in the incidence and mechanism of bone lesions in advanced prostate cancer.
Interventions
This study aims to improve knowledge around the way that cancer spreads in men with advanced prostate cancer who receive targeted radiation therapy and androgen deprivation therapy (ADT).
This study does not direct treatment and any treatment decisions will be based on the recommendation of your treating doctor. This study is looking at the effects on bone lesions in individuals receiving this treatment. At study enrolment a 68Ga-PSMA PET CT scan will occur as part of standard of care treatme
This study aims to improve knowledge around the way that cancer spreads in men with advanced prostate cancer who receive targeted radiation therapy and androgen deprivation therapy (ADT). This study does not direct treatment and any treatment decisions will be based on the recommendation of your treating doctor. This study is looking at the effects on bone lesions in individuals receiving this treatment. At study enrolment a 68Ga-PSMA PET CT scan will occur as part of standard of care treatment. A 68Ga-PSMA PET CT is a nuclear medicine imaging test used in prostate cancer and it has higher diagnostic efficacy than conventional imaging. Radioactive tracers are injected and then taken up by tissues in your body. Activity within your organs are then detected by the PET scanner which shows how tissue and organs are working. This test takes approximately 2 hours with the scan itself taking up to half an hour. This nuclear medicine examination is considered safe with almost no reported adverse reactions attributable to the radiopharmaceuticals used. This study requires two additional 68Ga-PSMA PET CT scans that are beyond standard of care. These scans occur at 6 and 12 months post enrolment. There are also optional blood tests that occur at enrolment, 6 and 12 months post enrolment. Blood tests are at the discretion of the individual participant.
Sponsors
The Garvan Institues of Medical Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Pathologically confirmed adenocarcinoma of prostate - Men presenting high risk of metastatic disease. - Gleason score 7-10 - Deemed suitable by a medical oncologist to start targeted radiation therapy and androgen deprivation therapy. - Blood tests: a) haemoglobin > 100g/L b) Platelets > 100 x 10^9/L c) Total white cell count > 4 x 10^9/L -Willingness to give written, informed consent and willingness to participate in and comply with the study.
Exclusion criteria
- Participants whose prostate cancer is not high risk of metastasis; - Participants who refuse to join the trial or are unable consent; - Participants who cannot remain still for at least 30 minutes to comply with imaging requirements. - Participants who have no PSMA receptor activity (approximately 5-10% of the population) and provide a negative baseline scan.
Outcome results
None listed