MRC Clinical Trials Unit at UCL
2nd Floor
90 High Holborn
London
WC1V 6LJ
Email: mrcctu.stampede@ucl.ac.uk
A low oestradiol result often indicates issues with compliance or incorrect patch application, so please check this with the patient. If this is the first time the oestradiol has been out of range, please run a repeat test in 4 weeks (being careful to time this the day before the patches are changed). If the oestradiol has been persistently out of range, please request advice from the STAMPEDE team (mrcctu.stampede@ucl.ac.uk).
If this is the first time the oestradiol has been out of range, please run a repeat test in 4 weeks (being careful to time this the day before the patches are changed). If the patient’s oestradiol is particularly high (>4000pmol/L) at any time, please run a repeat test in 1 week. If the oestradiol has been persistently out of range, please request advice from the STAMPEDE team (mrcctu.stampede@ucl.ac.uk).
Induction dose: If a patient's testosterone is still >1.7nmol/L after 4 weeks on the induction regime (4 patches changed twice weekly), they should remain on the induction regimen for another 4 week period, and have a repeat hormone test at the week 8 time point. Once the patient achieves a castrate level of testosterone (≤1.7nmol/L), they can be reduced to the maintenance regimen (3 patches changed twice weekly). If the testosterone does not reduce below 1.7nmol/L, please request advice from the STAMPEDE team (mrcctu.stampede@ucl.ac.uk).
Maintenance dose: If this is the first time the testosterone has been out of range, please run a repeat test in 4 weeks. If the testosterone has been persistently >1.7nmol/L, please request advice from the STAMPEDE team (mrcctu.stampede@ucl.ac.uk).
Please note: if both the testosterone and oestradiol are high, please check if the patient has been prescribed tamoxifen. Tamoxifen is not a permitted concomitant medication for patients using transdermal oestradiol as it can stop the patches functioning as they should.
Please check if the patient has been following the application instructions (“To apply the patch, remove the protective liner and then press onto skin immediately and hold for at least 30 seconds to ensure proper adhesion”). It is recommended that patches are placed on dry, intact and hairless skin and on areas where little wrinkling occurs. He can also try using tape to keep the patches on.
If applied correctly, the patient should be able to bath or shower as normal, however the patches might come off in very hot water or in a sauna. If patches become dislodged they should not put on extra patches, but apply their next set of patches when they are next due to be applied
There is no official guidance, but some sources have different suggestions, such as:
If you or your patients find any particularly effective methods, please share your knowledge with the STAMPEDE team!
Please ensure the patient is rotating the site of patch application between the shoulder girdle, back, upper arms, and buttocks and is waiting at least a week before applying patches to the same site. We advise the site team review the rash, and may advise the patient uses a low-dose steroid cream on any areas of irritation after removing the patches.
There is no washout period and the patient can commence tE2 treatment immediately after randomisation. Patients should stop taking anti-androgens (e.g. bicalutamide) before starting on tE2.
There is no washout period and patients may start their new treatment immediately.
Bayer (Manufacture of the Progynova TS 100 patches), announced that as of the 1st September 2022, there will be a change of wholesaler route to market.
Alliance will no longer be their selected wholesaler and Progynova TS 100 patches should be ordered through either AAH Pharmaceuticals Ltd or Phoenix Medical Supplies Ltd. Links to their websites are below:
https://www.aah.co.uk/s/
https://www.phoenixmedical.co.uk/en/
There should not be any interruption to supply and pricing has been applied with AAH and Phoenix.
Exceptional orders can also be placed with wholesalers when demand exceeds available stock at any particular time. This can be discussed with the wholesaler directly.
If you have any questions, please do not hesitate to contact the PATCH team (mrcctu.pr09@ucl.ac.uk).
Have another question or looking for more information? Why not check out the STAMPEDE Training Suite for the training slides detailing information on STAMPEDE.
STAMPEDE
MRC Clinical Trials Unit at UCL
2nd Floor
90 High Holborn
London
WC1V 6LJ
Email: mrcctu.stampede@ucl.ac.uk
STAMPEDE
Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy
See the latest News in STAMPEDE through the link to the right.