Cardiovascular Outcomes published at The Lancet:
We are delighted that recent PATCH data on the use of oestradiol in prostate cancer has recently been published in The Lancet. These results showed no excess of cardiovascular toxicity from the patches compared to LHRHa. A copy of the paper is available with this link until 2/4/2021 https://authors.elsevier.com/a/1cZgXV-4XDOCm
CORONAVIRUS (COVID-19) GUIDANCE:
VACCINE
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The PATCH Trial Management Group encourages everyone on the PATCH trial to 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 safe for patients with immunosuppression undergoing cancer treatment. Please discuss with your treating team regarding the timing of the vaccine according to your treatment schedule.
RECRUITMENT
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PATCH is now closed to recruitment.
TRIAL TREATMENT
The MHRA have issued new guidance for managing clinical trials during Covid-19:
We have summarised the points relevant to the PATCH trial below:
- It is important that patients with locally advanced and metastatic prostate cancer remain on ADT with effectively suppressed testosterone levels and as such the regular blood tests for patients on transdermal oestradiol patches remain important. We recognize that arrangements for regular blood tests may be subject to change and are grateful to sites for their help with this. Local services may be reconfigured to assist oncology patients with this aspect of their care and we would encourage research teams to engage with these options.
- It may be that sites are able to dispense longer prescriptions or utilise alternative delivery services to supply patients with their medication. For the latter, participants must consent verbally to providing contact details for shipping purposes and this should be documented in their notes. If a participant cannot sign for delivery due to self-isolation, then a follow up phone call could be used to confirm they have received the package.
- If it becomes impossible to monitor patients’ estradiol and testosterone levels, it may on occasion be necessary to switch patients to LHRHa treatment to ensure androgen suppression is maintained. However we appreciate that this may also be challenging given the pressures and reconfiguration of primary care at this time.
- We recognize that the usual recommendation to consider upfront Docetaxel in metastatic patients may not be appropriate in light of the ongoing situation. Similarly the timelines for any radical radiotherapy may also shift. We support clinical teams in making these decisions as per local guidelines and advice.
PATIENT MANAGEMENT AND FOLLOW-UP ASSESSMENTS
- Follow-up visits can be conducted via phone wherever necessary and this is preferable to postponing them. Please ensure source documents accurately reflect the type of follow up visit conducted.
- However, we appreciate that some visits will need to be postponed (and will fall outside of the stipulated visit windows) – please document where this occurs and let us know.
- For phone follow-up, sites should annotate next to any missed assessments (e.g. blood tests, scans, BP) to confirm the reason they have been missed and these will not be queried as missing data.
- For infections with Covid-19 that are life threatening/requires hospitalisation, please report on a SAE form under the ‘other important medical condition category’
SAMPLE COLLECTION
- Please do not send any further blood samples to Charing Cross Hospital, as they are unable to process these currently.
CONTACT WITH THE CTU TEAM/RETURNING DATA
- The CTU team are now all working remotely but can still be contacted on the normal numbers and via the trial mailbox.
- Please scan CRFs and send them to us via fax +44 (0)20 7670 4818 or via encrypted email to mrcctu.pr09@ucl.ac.uk until further notice. This is to enable the team working remotely to continue entering information in the PATCH database. Please continue to post them as well as sending electronically.
- As noted above, the line for randomisation has now changed: please call +44(0)20 7670 4941 between 09:00am and 17:00pm.
Are hormone patches a safe treatment for prostate cancer?
WHY OESTADIOL PATCHES?
Hormone therapy is a well-established practice in the treatment of prostate cancer, with oestradiol patches offering an alternative way of doing so with the potential benefits including less side-effects and better quality of life.
Current practice involves treating prostate cancer patients with hormone injections (LHRH agonist or antagonist), but there is accumulating evidence suggesting that LHRH therapy is associated with adverse metabolic changes and increased risk of heart disease and type II diabetes.
The purpose of either form of hormone therapy is to suppress the level of testosterone which encourages the growth and spread of prostate cancer. When using the hormone injections there are side-effects related to the loss of oestrogen which is present in low levels in the male body. Oestrogens are involved in metabolic regulation (for example blood glucose and cholesterol) and in the uptake of calcium in bone health. By using oestradiol patches to suppress testosterone, these side-effects can be avoided.
WHO CAN TAKE PART?
The trial is for patients with newly-diagnosed locally advanced or metastatic prostate cancer, or relapsing patients who have had previous radical treatment but now have a rising PSA level (Prostate Specific Antigen, the specific marker used to track the severity of prostate cancer).
For the full inclusion/exclusion criteria, see the protocol in the Documents section.
