Efficacy analysis of a phase III study of androgen deprivation
therapy (ADT) +/- docetaxel (D) for men with biochemical relapse (BCR) after prostatectomy.
Expectant management was the leading treatment in these patients, followed by androgen deprivation
. Even among those who also consulted a urologist and a radiation oncologist, 51% chose watchful waiting, whereas just over a third (34%) opted for radiation therapy.
Absolute prostate-specific antigen value after androgen deprivation
is a strong independent predictor of survival in new metastatic prostate cancer: data from Southwest Oncology Group Trial 9346 (INT0162).
Overall, men treated with androgen deprivation
therapy had a 2.5% risk of cardiac death at 5 years, compared with 0.6% in men who did not get hormones.
We excluded patients with incomplete pathological information, treated with pre-operative androgen deprivation
, and who were previously treated with prostate radiation.
"While the absolute risks of fracture and cardiovascular mortality are low among men treated with androgen deprivation
therapy, preventive treatments may further reduce the risk of these serious adverse outcomes related to androgen deprivation
therapy," the authors wrote.
This patient was one of the four who opted for androgen deprivation
therapy, either with bilateral orchiectomy or treatment with GnRH agonists, is the mainstay of treatment for metastatic prostate cancer.
The McMaster data presented at the 2014 meeting adds to this body of knowledge as it appears that at least part of the deleterious metabolic effects of androgen deprivation
therapy (ADT) may lie in its FSH-suppressing activity and not all due to lowering of testosterone.
They observed that prostate cancer patients, who received bisphosphonate treatment and androgen deprivation
therapy, did show an increase in bone loss.
After 10 years on androgen deprivation
therapy, about 20% of men will have experienced a fracture, a risk fivefold greater than in age-matched controls.
This US FDA submission is based on the company's Phase 3 data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which assessed the safety and efficacy of apalutamide versus placebo, in men with non-metastatic CRPC who have a rapidly rising prostate specific antigen (PSA) despite receiving continuous androgen deprivation