None listed
Conditions
Brief summary
This phase 1 study will aim to predict a response to radiotherapy treatment in prostate cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with prostate cancer and have been recommended radiotherapy treatment. Study details Participants will undergo normal radiotherapy treatment with the addition of up to 5 MRI scans prior to and following radiotherapy treatment, up to 2 PSMA PET scans prior to and following radiotherapy treatment and up to 5 pathology blood tests prior to and following radiotherapy treatment. This study will determine the pre-treatment clinical and radiographic predictors of local recurrence in prostate cancer patients treated with radiotherapy.
Interventions
This study collects imaging data in the form of multiparametric magnetic resonance imaging (mpMRI) prior to initiation of therapy(s) and at three time points post radiotherapy, as well as Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) prior to the initiation of radiotherapy and at 18-months post radiotherapy. Prostate specific antigen (PSA) blood tests represent the standard measure of treatment response and will be collected at time points in addition to non-stand
This study collects imaging data in the form of multiparametric magnetic resonance imaging (mpMRI) prior to initiation of therapy(s) and at three time points post radiotherapy, as well as Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) prior to the initiation of radiotherapy and at 18-months post radiotherapy. Prostate specific antigen (PSA) blood tests represent the standard measure of treatment response and will be collected at time points in addition to non-standard blood tests corresponding to collection of imaging data in participants undergoing standard radiotherapy for prostate cancer treatment. The interventions involved in this study are as follows; PSMA PET at baseline (may be standard at the site) and again at 18 months post radiotherapy treatment (not standard). The PSMA PET scan involves the use of an intravenously administered radioactive drug (tracer) followed by the scan. The PSMA PET scan will be performed by a suitably qualified allied health professional. mpMRI - three additional MRI scans with contrast above what is normal standard of care. The MRI scans will involve the use of a contrast agent administered intravenously by the treating doctor. The standard of care MRI used for radiotherapy planning will utilise contrast which may not be standard of care in some centres. The MRI scan will be performed by a suitably qualified allied health professional. mpMRI scans will be performed at time of radiotherapy planning, and then 6, 12 and 18 months post radiotherapy treatment. Full Blood Count (FBC) and Electrolytes, Urea and Creatinine (EUC) at four timepoints (prior to radiotherapy planning, and then 6, 12 and 18 months post radiotherapy treatment) which are not standard blood tests for this group of patients. Measurement of Testosterone is also not standard in patents not on androgen deprivation therapy (ADT). Patients who are being treated using ADT as part of their standard treatment for their prostate cancer compared to those that who are not being treated using ADT will complete one additional mpMRI and one additional blood test prior to the commencement of ADT in addition to the interventions outlined above.
Sponsors
University of Sydney
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
Biopsy proven localised prostate cancer. Great than or equal to 18 years of age. Willing and able to comply with all study requirements. Signed, written and informed consent. Completed MRI safety screening as per local policy. Up to 4 months ADT prior to radiotherapy. No more than 20 participants who receive ADT.
Exclusion criteria
Mentally impaired participants or participants for who obtaining informed consent would be difficult. Unable to undergo an MRI examination or has contraindications to MRI. Inadequate renal function for contrast administration (eGFR <60 ml/min) at baseline imaging. Participants who have been clinically diagnosed with severe claustrophobia. Prior pelvic radiotherapy. Any prosthetic implants such as metallic hip prostheses that may cause artefacts in the imaging studies.
Outcome results
None listed