Phase 3 Randomized Controlled Trial of Androgen Deprivation Therapy with or Without Docetaxel in High-risk Biochemically Recurrent Prostate Cancer After Surgery (TAX3503)

Gender-Specific Impact of Sex Hormones on the Immune System

“…Androgen deprivation therapy (ADT) in patients affected by castration-sensitive prostate cancer leads to neutropenia [ 43 ] and to an aberrant neutrophilic phenotype, with more banded and immature neutrophils [ 28 ]. Furthermore, hypogonadal men treated with Te show an increased number of neutrophils ( Table 1 ) [ 30 ] with a reduction in superoxide anion and lipid peroxidation, and an increase in nitric oxide concentrations [ 44 ].…”

Should androgen deprivation therapy and other systemic treatments be used in men with prostate cancer and a rising PSA post-local treatments?

“…When considering docetaxel, the two reported phase III trials reported on PFS, with one failing to show benefit, and the other showing borderline benefit, whilst OS data were not mature in the former and not reported in the latter. 83,84 Both studies aimed to include high-risk BCR patients, but their criteria for this were not identical, and they also differed in the docetaxel regimen and number of cycles. This is reminiscent of the landscape of docetaxel trials for locally advanced, non-metastatic disease, with contradicting results amongst trials that differed in the definition of high-risk disease, docetaxel regimen, accrual power and timing of treatment, and failure to show OS survival benefit despite improvements in failure-free survival.…”

“…In the phase III TAX 3503 trial, 83 which was terminated early, 413 patients high-risk BCR patients (PSA-DT ⩽ 9 months and PSA ⩾ 1 ng/ ml) were randomised to receive 18 months of ADT (leuprolide and bicalutamide), with or without, docetaxel (75 mg/m 2 IV 3-weekly, 10 cycles). The final analysis included data from the trial and a subsequent registry created after completion of study accrual to secure the primary endpoint.…”

Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy

“…The TAX 3503 study randomized patients (n = 413) with BCR after primary RP to docetaxel (75 mg/m 2 every 3 weeks for up to 10 cycles) with ADT for 18 months compared to ADT alone. 39 Patients were eligible based on a PSA ≥ 1.0 ng/mL or PSADT of ≤ 9 months. No statistically significant differences were identified between the group that received docetaxel versus the group that received no docetaxel with respect to PFS or OS.…”