Major pharmaceutical companies continually research and develop new medications and treatments, which must be shown to be safe and effective before the FDA ( Food and Drug Administration) approves them and doctors can prescribe them to patients. Through prostate cancer clinical trials, researchers test the effects of new medications on a group of volunteers with prostate cancer. Following a strict protocol and using carefully controlled conditions, researchers evaluate the investigational drugs under...
Added text to state that in a registry of men with rising prostate-specific antigen (PSA) after initial treatment of clinically localized prostate cancer, 19 of 510 men who had undergone radical prostatectomy complained of reduced penile size; however, the data were based upon physician reporting of patients' complaints rather than direct patient questioning or before-and-after measurement of penile length (cited Parekh et al. as reference 51).
Added text to state that the use of androgen deprivation therapy may be associated with complaints of penile shortening, although the data are very limited. Also added text to state that in a registry study of men with rising PSA after initial treatment of clinically localized prostate cancer treated with radiation therapy plus androgen deprivation therapy, 6 of 225 men complained of reduced penile size.
Stage IV Prostate Cancer Treatment
Added text to state that a larger randomized trial designed to determine whether survival using intermittent androgen therapy (IAD) is noninferior to continuous deprivation could not rule out a 20% higher relative risk of death using intermittent therapy (cited Hussain et al. as reference 39 and level of evidence 1iiA). Also added text to state that the trial was designed as a noninferiority study to rule out a survival rate that was 20% worse in the IAD therapy group compared with the continuous androgen therapy group.
Added text to state that in a preplanned quality-of-life analyses, intermittent therapy was associated with better erectile function and mental health at 3 months following random assignment, for an additional year of quality-of-life assessment (cited level of evidence 1iiC).
Recurrent Prostate Cancer Treatment
Added text to state that some forms of hormonal therapy are effective in the management of metastatic hormone–refractory prostate cancer.
Added text to state that abiraterone acetate is an inhibitor of androgen biosynthesis that works by blocking cytochrome P450c17 (CYP17). In a double-blinded, placebo-controlled trial, 1,088 men with progressing hormone refractory disease, no prior chemotherapy, and Eastern Cooperative Oncology Group performance status (PS) 0 to 1 were given prednisone (cited Ryan et al. as reference 16). The coprimary endpoints were radiologic progression-free survival and overall survival.