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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Robert
Bristow
Robert.bristow@manchester.ac.uk
Martin
Swinton
m.swinton@nhs.net
Malignant neoplasms of male genital organs
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Due to the rapid growth, tumour demand for oxygen often is higher than what can be delivered by the newly forming blood vessels. Tumour adaption to this imbalanced oxygen supply and demand (hypoxia) is associated with poor prognosis and genetic changes (genomic instability) that allow it to become more resistant to chemo- and radiotherapy. Patients with hypoxic tumours therefore die earlier. Limited information is available on hypoxia in newly diagnosed prostate cancer, especially to what degree hypoxia in the prostate tumour is associated with the presence of metastases to bones. This study will therefore aim to determine the association between hypoxia in the primary tumour with the presence of skeletal metastases. Secondly this study will aim to determine if hypoxia is also present in the metastatic sites themselves. Hypoxia presence will be determined by using a hypoxia identifying stain (by giving a patient a tablet of the stain to take orally) and by identifying genomic alterations that are associated with hypoxia. After taking the tablet of the hypoxia marker (Pimonidazol) patients will receive both a biopsy of the prostate and of one of the bone metastasis. Patients who already have undergone a diagnostic biopsy of the prostate may opt to not undergo a second biopsy solely for research purposes, in which case existing archival samples from the diagnostic biopsies willl be assessed to address the research questions. This will, however, limit the information contant to be retrieved from the study assessments. The presence or not as well as the degree of hypoxia in both sites will be assessed.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Validation of investigation /therapeutic procedures;
You can take part if:
You may not be able to take part if:
* Involvement in the planning and/or conduct of the study (applies to staff at the study site); * Previous enrolment in the HYPROGEN study; * As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. uncompensated respiratory, cardiac, hepatic or renal disease); * Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study; * Any investigational agents or study drugs from a previous clinical study within 30 days of the first tissue collection; * Prior treatment of localized prostate cancer including radiotherapy and/or androgen-deprivation therapy; * Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements; * Contra-indications to MRI (incl. pacemakers etc.) (cohort B only); * Bone metastases in difficult to reach areas or areas which might be at risk for pathological fracture post biopsy as judged by biopsying radiologist / chief investigator; * Increased risk of bleeding as a result of biopsy; * History of bleeding disorders or thrombocytopenia (platelets <100/nL); * Concomitant treatment with anticoagulant therapy, e.g. warfarin/low molecular weight heparin or Anti-Xa-inhibitors and other NOACs, if temporary cessation medically not justifiable; * Current urinary tract infection (UTI) or prostatitis.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by THE CHRISTIE NHS FOUNDATION TRUST and funded by Prostate Cancer UK .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 44638
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
