Phase 3 randomized controlled trial of androgen deprivation therapy with or without docetaxel in high-risk biochemically recurrent prostate cancer after surgery (TAX3503) Journal Article
| Authors: | Morris, M. J.; Mota, J. M.; Lacuna, K.; Hilden, P.; Gleave, M.; Carducci, M. A.; Saad, F.; Cohn, E. D.; Filipenko, J.; Heller, G.; Shore, N.; Armstrong, A. J.; Scher, H. I. |
| Article Title: | 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 following testosterone recovery to noncastrate levels (testosterone >50 ng/dl). Secondary endpoints included time to testosterone recovery, overall survival (OS), quality of life, and safety. RESULTS AND LIMITATIONS: Between September 2007 and May 2011, 413 patients were assigned to ADT ± docetaxel. In 2012, following completion of accrual and treatment, the sponsor withdrew support of the study, and in 2013, a registry was created to secure the primary endpoint. The final analysis included data from the original trial and registry. At a median follow-up of 33.6 mo, 260 patients demonstrated testosterone recovery, which occurred similarly between groups. ADT plus docetaxel trended toward a nonclinically meaningful improvement in PFS (median 26.2 vs 24.7 mo) for the testosterone-recovered population (218 events, hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.61-1.04) and in OS for the intention-to-treat population (medians not reached, HR 0.51, 95% CI 0.23-1.10). Grade ≥3 adverse events occurred more frequently in the ADT plus docetaxel group (48.0% vs 10.8%). CONCLUSIONS: TAX3503 did not demonstrate a meaningful benefit of adding docetaxel to ADT in patients with high-risk BCR. Testosterone recovery was unaffected by addition of docetaxel to ADT. PATIENT SUMMARY: Addition of docetaxel to androgen deprivation therapy did not meaningfully improve outcomes for men with high-risk biochemically recurrent prostate cancer. Copyright © 2021. Published by Elsevier B.V. |
| Keywords: | docetaxel; prostate cancer; biochemical recurrence; nonmetastatic; castration sensitive; rising prostate-specific antigen |
| Journal Title: | European Urology Oncology |
| Volume: | 4 |
| Issue: | 4 |
| ISSN: | 2588-9311 |
| Publisher: | Elsevier BV |
| Date Published: | 2021-08-01 |
| Start Page: | 543 |
| End Page: | 552 |
| Language: | English |
| DOI: | 10.1016/j.euo.2021.04.008 |
| PUBMED: | 34020931 |
| PROVIDER: | scopus |
| PMCID: | PMC9386576 |
| DOI/URL: | |
| Notes: | Article -- Erratum issued, see DOI: 10.1016/j.euo.2022.08.001 -- Export Date: 1 October 2021 -- Source: Scopus |
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