None listed
Conditions
Brief summary
This study will aim to predict a response to radiotherapy treatment using multiparametric MRI 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 radiotherapy treatment with the addition of 3 MRI scans prior to and following radiotherapy treatment and 3 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 radiotherapy and at two time points post radiotherapy. Prostate specific antigen (PSA) blood tests represent the standard measure of treatment response and will be collected at each time point 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; mpMRI - three additional MRI scans with contrast above what is normal standard of care. The MRI scans will involve the use of the contrast agent Gadovist (dosage given per patient weight will be 0.1 mL/kg, equating to 0.1 mmol/kg) administered intravenously by the treating doctor. The mpMRI scan will be performed by a suitably qualified allied health professional. Scans will be performed at time of radiotherapy planning, and then 6 and 12 months post radiotherapy treatment. Full Blood Count (FBC) and Testosterone will be obtained at three timepoints (prior to radiotherapy planning, and then 6 and 12 months post radiotherapy treatment) which are not standard blood tests for this group of patients. Measurement of Testosterone is also not standard in patents who are not receiving androgen deprivation therapy (ADT). Measures of oxygen level in prostate biopsy tissue collected during standard of care biopsy procedures before treatment will be assessed using immunohistochemistry and will be compared with the mpMRI and blood tests. These immunohistochemistry analyses are not standard of care. Adherence to the study protocol will be recorded in case report forms.
Sponsors
Study design
Eligibility
Inclusion criteria
Signed, written and informed consent Biopsy proven localised prostate cancer >= 18 years of age Willing and able to comply with all study requirements Completed MRI safety screening and contrast agent safety screening
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 threshold according to protocol) at baseline imaging Participants who are unable or unwilling to remain still in MRI for up to 60 minutes Prior pelvic radiotherapy Any prosthetic implants such as metallic hip prostheses that may cause artefacts in the imaging studies Prescribed ADT