MRC Clinical Trials Unit at UCL
90 High Holborn
Please review this page for updates on COVID-19; we are continuously updating information as the situation develops.
There have been recent updates on the following sections:
The STAMPEDE Team recommend that everyone on the STAMPEDE trial have a Covid vaccine if they are advised to do so by their hospital doctor or GP. The Covid vaccines are NOT live vaccines and therefore considered safe for patients undergoing cancer treatment. Please discuss with your treating team regarding the timing of the vaccine according to your treatment schedule.
Abiraterone, Prednisolone and Enzalutamide:
1.1 - Continued access to abiraterone and enzalutamide for Patients randomised to arms G & J
From protocol 22 onwards patients who have not met the criteria for stopping treatment in arm G and arm J (please refer to protocol 21 section 8.1.1. Stopping Research Treatment: Abiraterone, Enzalutamide + Abiraterone) will have continued access to these treatments through the trial, as long as there is no other available option outside of the trial. If a therapeutic alternative becomes commercialized and available for these patients according to local guidelines, patients should switch to this option and the treatment access through the trial should be stopped. Patients on Arm J can choose to continue on both or either treatment alone. There will be limited data collected on these patients, which will include SAE reporting (please see section 11) and an end of treatment CRF if a patient comes off either abiraterone or enzalutamide or both. No data collection is required for any other patients in arms G or J or the contemporaneous control arm A patients randomised between November-2011 and March-2016.
Local guidelines for abiraterone and enzalutamide treatment should be followed for safety assessments, dose reductions or stopping of treatment due to toxicity. Local guidelines should align with previously published guidelines, namely NICE guidance, St Luke’s SACT policy or EAU guidelines. Sites are required to confirm which guidelines they follow and if none of these three are adhered to, sites are required to provide their local guidelines for review and recording by the MRC CTU and the TMG.
Due to current NHS commissioning of AR therapy, patients allocated to Arms G and J do not fall under the provision of AR therapies. Therefore, the trial will continue to provide access to abiraterone and/or enzalutamide for those patients who are still on treatment. If this situation changes, patients will be transferred to NHS provision.
1. Supply for pharmacy:
2. Safety checks and treatment administration:
Arm K dispensing:
Arm L dispensing:
Accessing Trial Treatment and Prescriptions
The STAMPEDE team understand the difficulty of reporting SAEs at this unprecedented time. The current MHRA guidance is now that sites should report events within 24 hours of awareness of the event to the sponsor. They do also state “Particular attention should be paid to timely reporting of suspected unexpected serious adverse reactions (SUSARs) which put participant safety at risk on a trial or have the potential to impact participants of other trials. Every effort should be made to notify MHRA in this case”. We understand sites may not be aware of the events to be able to report within the 24 hour required timeline and therefore please can sites ensure that a systematic review occurs when there is capacity and the research team is in place to ensure any SAEs are reported to the MRC CTU within the 24 hour timeline.
PATIENT MANAGEMENT AND FOLLOW-UP ASSESSMENTS
We understand there will be some necessary changes on how patients are followed up during this period, we will work closely with you to try and aid where we can.
The MHRA have given clear guidance about recording deviations, as there is a high probability of these occurring while research teams deal with the challenges of the COVID-19 pandemic. To aid in the identification and tracking of these please follow the below guidance:
Ensure all deviations are recorded using the Site Deviation Log
Site Deviation Log Guidance
There is a high probability of deviations occurring while research teams deal with the challenges of the COVID-19 pandemic. Ensure all deviations that occur are recorded using the Site deviation log.
When using the log first ensure the tab “Deviations” is selected at the bottom of the spreadsheet, and ensure your site name and site number is entered into the appropriate cells. Fill in a row for each single deviation, such as missed safety bloods, a missed blood pressure measurement or if the follow up has been missed entirely. Some cells are free text fields whilst others have drop down menus for you to select the most appropriate answer, such as the below.
Select which category you believe best describes the issue in the “Deviation category”. The “Current Status” column should be considered open or closed depending on status of resolution. The “Severity” category is intended as a guide on whether a deviation needs to be reported to the STAMDPEDE team immediately.
Critical Deviation - Any change, divergence, or departure from study protocol that significantly impacts patients’ rights, safety and/or well-being or significantly impacts the integrity and/or reliability of study results.
Major Deviation - Any change, divergence, or departure from study protocol that may impact the patients’ rights, safety and/or well-being or significantly impact the completeness, accuracy and/or reliability of study data
Other Deviation - Any deviation that will not adversely affect patients’/data but should be dealt with appropriately.
If you believe any of the issues identified to be a Critical or Major Deviation, please contact the STAMPEDE team as soon as possible. If you are unsure if the deviation meets either category, do contact the STAMPEDE team who will be happy to review the issue with you.
The tab “PI Sign Off” is intended for PI review of closed deviations, this can be completed post Covid-19 pandemic.
Examples of deviations that will need to be logged include:
These deviations should also be captured on CRFs by indicating when data points have been missed due to the current COVID-19 pandemic, by clearly writing “COVID-19” next to the field with the missing data. Deviation logs where possible should be sent to the STAMPEDE team on a periodic basis. This will enable the study team to assess the impact of this challenging period on the study results at the time of analysis. If you have any questions about how to use the log or a query about how to classify a deviation, please do not hesitate to get in touch with the team.
Please continue to collect Metabolic Sub-Study blood samples as normal.
Please note, if you require additional kits please inform the STAMPEDE team at MRCCTU.email@example.com or Michelle at The Manchester Cancer Research Centre Biobank at firstname.lastname@example.org
Samples will be shipped in batches, along with the sample transfer log and freezer box map, to the central biobank once sites have filled two freezer boxes with samples. Once two freezer boxes are filled, please liaise with the team to organise shipment.
Please document on the relevant CRF where samples have been missed, and reasons causing the missed sample.
CONTACT WITH THE CTU TEAM/RETURNING DATA
MRC Clinical Trials Unit at UCL
90 High Holborn
Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy
See the latest News in STAMPEDE through the link to the right.