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
VACCINE
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
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:
PATIENT MANAGEMENT AND FOLLOW-UP ASSESSMENTS
SAMPLE COLLECTION
CONTACT WITH THE CTU TEAM/RETURNING DATA
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.
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.