The edition · Urology
Gynaecomastia on enzalutamide has nothing to do with the testosterone
Forty-two per cent of men on intermittent enzalutamide monotherapy developed gynaecomastia, and neither peak testosterone nor how long it stayed up predicted who. Plus a Class II recall on compounding-grade tadalafil, and a four-arm stone trial worth reading carefully.
The edition in brief
In 38 men with biochemically recurrent prostate cancer given three months of intermittent enzalutamide with no androgen deprivation, serum testosterone rose from a median of 316 ng/dL to a median peak of 832.5 — a 63% median increase — and gynaecomastia was reported by 16 patients (42%). Neither peak testosterone nor the duration of raised testosterone correlated with it, and having gynaecomastia in the first course did not reliably predict it in the second. The practical consequence is that testosterone monitoring cannot be used to anticipate or manage this toxicity, and counselling should be based on the 42% rate rather than on a level. Separately, the FDA has classified a recall of tadalafil USP active pharmaceutical ingredient, supplied in 500 g bags for prescription compounding only by Shoolin Pharma Chem LLP, as Class II following CGMP deviations noted during inspection; the recall is ongoing. This is bulk starting material rather than a finished product, and the relevance to a urology clinic is the compounded and unlicensed tadalafil that patients buy outside a prescription. A four-arm randomised trial in 100 patients with kidney stones compared a traditional Chinese medicine formula, hydrogen-rich water, both, and neither, alongside guideline treatment for 12 weeks. Total effective rates were 76% for the formula, 80% for the combination, 32% for hydrogen-rich water alone and 28% for the control — a pattern in which nearly all of the effect belongs to the herbal formula, not the hydrogen. IMPALA-ERAS, a 2,290-patient pragmatic cluster-randomised trial including urological surgery, will test perioperative intravenous lidocaine within established ERAS pathways.
Class II recall on compounding-grade tadalafil
Ask where the tadalafil came from — the recall is on bulk material feeding compounded and unlicensed supply.
A four-arm stone trial that shows which half of the combination is working
Nothing to adopt: the benefit in this trial belongs to the herbal formula, not the hydrogen-rich water.
A 2,290-patient test of whether lidocaine earns its place in ERAS
A properly sized answer on perioperative lidocaine is coming; the practice remains unproven inside a full ERAS pathway.
The stone you retrieved is a test result — send it
Analyse every stone you retrieve; without the composition the prevention plan is guesswork.
Stop using testosterone levels to explain gynaecomastia on enzalutamide
Counsel on the 42% rate up front; no testosterone level will tell you who gets gynaecomastia.
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