None listed
Conditions
Brief summary
The purpose of this study is to determine if the radio-tracer 18F-PSMA-1007 has similar diagnostic accuracy to the radio-tracer 68Ga-PSMA-11 in patients with prostate cancer metastasis. Who is it for? You may be eligible for this study if you are aged 60 and above and currently have prostate cancer. Study details. Participants will receive a PET scan using the radio-tracer 68Ga-PSMA-11 as normal standard-of-care. Participants will be asked to return for a second PET scan within two weeks of the first PET scan. This second PET scan will be performed using the radio-tracer 18F-PSMA-1007. The only tests involved with this study will be PET scans. By comparing the two radio-tracers (68Ga-PSMA and 18F-PSMA) we hope to validate the use of 18F-PSMA for diagnostic use in screening and staging prostate cancers. 18F-PSMA has slightly different properties to 68Ga-PSMA that will make it a more versatile tool for diagnosing prostate cancer. Its longer half-life means that 18F-PSMA will be able to be shipped to regional centres to be used instead of cancer patients having to travel to a large metropolitan hospital.
Interventions
Two radiotracers will be utilised in this study. The first, 68Ga-PSMA-11, the current gold standard PET tracer for identifying prostate cancers. The second, 18F-PSMA-1007, will be assessed against the 68Ga-PSMA-11.
Patients will be administered 68Ga-PSMA first, then imaged, and after a period of time when the tracer has been excreted from the body, the patients will be administered 18F-PSMA and then imaged.
Patients will not need to be admitted to hospital. Patients will be injected with radiotr
Two radiotracers will be utilised in this study. The first, 68Ga-PSMA-11, the current gold standard PET tracer for identifying prostate cancers. The second, 18F-PSMA-1007, will be assessed against the 68Ga-PSMA-11. Patients will be administered 68Ga-PSMA first, then imaged, and after a period of time when the tracer has been excreted from the body, the patients will be administered 18F-PSMA and then imaged. Patients will not need to be admitted to hospital. Patients will be injected with radiotracer according to usual standard-of-care practice and will undergo standard-of-care PET imaging 45-90 minutes post-injection. PET imaging will start at the knees and move towards the head. Two and a half minute bed positions will be acquired from thighs to skull vertex with the exception of two bed positions over the pelvis which will be for 4 minutes. Overall, imaging should be approximately 45-60 minutes. A nuclear medicine doctor will administer the radiotracer and analyse the imaging. Participants will be followed up over 5 years. The minimum period of time between the first tracer and the second tracer being administered is five half-lives (approx. 340 minutes). The maximum period of time between tracers being administered is two weeks. All participants will have 68Ga-PSMA first followed by 18F-PSMA. This does not need to be randomised as the nuclear medicine clinician will know immediately (from the PET scan) which tracer has been used. Therefore, there is no need to randomise as there is no direct way to 'blind' the clinician as to which tracer has been used.
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients: 1. Age equal to or greater than 60 years. 2. Patient has provided written informed consent for participation in this trial 3. The patient is able to comply with the required study procedures Primary staging cohort: 1. Newly-diagnosed, untreated, biopsy proven adenocarcinoma of the prostate gland. 2. Patients must have at least one of the following features - Gleason group 3, 4 or 5 - PSA >20 ng/mL within 12 weeks prior to referral - Clinical stage =T3 Biochemical recurrence restaging cohort: A. Prostatectomy cohort 1. Complete excision of the prostate gland, R0- or R1- resection 2. PSA =0.2ng/mL after nadir following radical prostatectomy B. Radiotherapy cohort 1. Organ-preserving local treatment (external beam radiation therapy, brachytherapy, seed implantation, high intensity focused ultrasound) 2. PSA increase of 2.0ng/mL greater than the lowest recorded PSA value following therapy Known metastatic disease restaging cohort: 1. Known distant metastatic prostate cancer (M1 a/b/c) diagnosed by at least one of the following: - 68Ga-PSMA-11 demonstrating metastatic disease - WBBS demonstrating lesions characteristic of prostate cancer metastases - CT or MRI imaging demonstrating lesions characteristic of prostate cancer metastases - Histological confirmation of prostate cancer metastasis
Exclusion criteria
1. Significant intercurrent comorbidity that, in the opinion of the investigators, would limit compliance with the study protocol 2. Change in prostate cancer therapy after the 68Ga-PSMA-11 PET/CT but before the 18F-PSMA-1007 PET/CT.
Outcome results
None listed