Trial reportCancer2013
Adjuvant leuprolide with or without docetaxel in patients with high-risk prostate cancer after radical prostatectomy (TAX-3501): important lessons for future trials.
Trial report in Cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- MRI software and cognitive fusion biopsies in people with suspected prostate cancer: a systematic review, network meta-analysis and cost-effectiveness analysis.Health technology assessment (Winchester, England) · 2024Pooled it
- Addition of docetaxel or bisphosphonates to standard of care in men with localised or metastatic, hormone-sensitive prostate cancer: a systematic review and meta-analyses of aggregate data.The Lancet. Oncology · 2016Pooled it
- Trial
- Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial.Lancet (London, England) · 2016 · on this mapTrial
- Trial
- Novel insights into post-marketing AEs associated with leuprorelin: A comprehensive analysis utilizing the FAERS database.Heliyon · 2024Article
- Is time to castration resistant prostate cancer a potential intermediate end-point for time to metastasis among men initiating androgen deprivation therapy for non-metastatic prostate cancer with rapid PSA doubling time (<9 months)?Prostate cancer and prostatic diseases · 2023Article
- Current Status and Future Perspective on the Management of Lymph Node-Positive Prostate Cancer after Radical Prostatectomy.Cancers · 2022Review
- Prostate cancer dormancy and recurrence.Cancer letters · 2022Review
- Machine Learning Approach for Active Vaccine Safety Monitoring.Journal of Korean medical science · 2021Article
- Cancer epithelia-derived mitochondrial DNA is a targetable initiator of a paracrine signaling loop that confers taxane resistance.Proceedings of the National Academy of Sciences of the United States of America · 2020Article
- Clinical studies investigating the use of leuprorelin for prostate cancer in Asia.Prostate international · 2020Review
- The docetaxel debate: impact of chemotherapy in high-risk non-metastatic prostate cancer.Translational andrology and urology · 2019Article
- The addition of chemotherapy in the definitive management of high risk prostate cancer.Urologic oncology · 2018Review
- Systemic treatments for high-risk localized prostate cancer.Nature reviews. Urology · 2018Review
- The effect of additional chemotherapy on high-risk prostate cancer: a systematic review and meta-analysis.OncoTargets and therapy · 2018Review
- Docetaxel in prostate cancer: a familiar face as the new standard in a hormone-sensitive setting.Therapeutic advances in medical oncology · 2017Review
- The very-high-risk prostate cancer: a contemporary update.Prostate cancer and prostatic diseases · 2016Review
- The STAMPEDE trial: paradigm-changing data through innovative trial design.Translational cancer research · 2016Article
- Hormonal therapy and chemotherapy in hormone-naive and castration resistant prostate cancer.Translational andrology and urology · 2015Review
Corrections and comments
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Authors and funding
8 authors at 6 institutions in 4 countries.
Funding
Abstract
backgroundThe current trial evaluated 2 common therapies for patients with advanced prostate cancer, docetaxel and hormonal therapy (HT), in the surgical adjuvant setting.
methodsTAX-3501 was a randomized, phase 3, adjuvant study post-radical prostatectomy (RP) in high-risk patients with prostate cancer (n=228) comparing 18 months of HT with (CHT) without docetaxel chemotherapy either immediately (I) or deferred (D). High-risk disease was defined as a 5-year freedom-from-disease-progression rate of ≤ 60% as predicted by a post-RP nomogram. Progression-free survival (PFS), including prostate-specific antigen disease recurrence, was the primary endpoint. The authors also assessed the accuracy of the nomogram and analyzed testosterone recovery in 108 patients treated with HT who had at least 1 posttreatment testosterone value.
resultsBetween December 2005 and September 2007, 228 patients were randomized between the treatment cohorts. TAX-3501 was terminated prematurely because of enrollment challenges, leaving it underpowered to detect differences in PFS. After a median follow-up of 3.4 years (interquartile range, 2.3-3.8 years), 39 of 228 patients (17%) demonstrated PSA disease progression, and metastatic disease progression occurred in 1 patient. The median time to baseline testosterone recovery after the completion of treatment was prolonged at 487 days (95% confidence interval, 457-546 days). The nomogram's predicted versus observed freedom from disease progression was significantly different for the combination D(HT) and D(CHT) group (P<.00001).
conclusionsTAX-3501 illustrated several difficulties involved in conducting postoperative adjuvant systemic trials in men with high-risk prostate cancer: the lack of consensus regarding patient selection and treatment, the need for long follow-up time, nonvalidated intermediate endpoints, evolving standard approaches, and the need for long-term research support. Except for selected patients at very high-risk of disease recurrence and death, surgical adjuvant trials in patients with prostate cancer may not be feasible.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.