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

ABSTRACT:

Background

No standard of care exists for patients with high-risk biochemical recurrence (BCR) after prostatectomy.

Objective

To evaluate whether addition of docetaxel to androgen deprivation therapy (ADT) improved progression-free survival (PFS) in high-risk BCR patients.

Design, setting, and participants

TAX3503 was a multicenter phase 3 trial that randomized patients with high-risk BCR to ADT for 18 mo ± docetaxel (75 mg/m² q3w for ten cycles). Eligibility included prostate-specific antigen (PSA) ≥1.0 ng/ml after prostatectomy alone or after postoperative radiation therapy, PSA doubling time ≤9 mo, and absence of metastases on computed tomography and bone scintigraphy.

Outcome measurements and statistical analysis

The primary endpoint was PFS foll

SUBMITTER: Morris MJ 

PROVIDER: S-EPMC9386576 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature