Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2008
Phase II trial of docetaxel with rapid androgen cycling for progressive noncastrate prostate cancer.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis 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, 1 synthesis or guideline pooled it.
- Neutropenia and docetaxel exposure in metastatic castration-resistant prostate cancer patients: A meta-analysis and evaluation of a clinical cohort.Cancer medicine · 2019Pooled it
- Accelerating Drug Development in Hormone-Naïve Prostate Cancer through Multimodal Therapy Strategies: The MetaCURE Phase 2 Randomized Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Toxicity in patients receiving adjuvant docetaxel + hormonal treatment after radical radiotherapy for intermediate or high-risk prostate cancer: a preplanned safety report of the SPCG-13 trial.Prostate cancer and prostatic diseases · 2012Trial
- Castration-dependent pharmacokinetics of docetaxel in patients with prostate cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010Trial
- Treatment Response and Outcomes of Prostate Cancer Patients Carrying the Germline MMS22L F722fs Mutation.The Prostate · 2026Article
- Should androgen deprivation therapy and other systemic treatments be used in men with prostate cancer and a rising PSA post-local treatments?Therapeutic advances in medical oncology · 2021Review
- 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
- Drug development for noncastrate prostate cancer in a changed therapeutic landscape.Nature reviews. Clinical oncology · 2018Review
- Article
- Exploiting Epigenetic Alterations in Prostate Cancer.International journal of molecular sciences · 2017Review
- A Pilot Study of a Multimodal Treatment Paradigm to Accelerate Drug Evaluations in Early-stage Metastatic Prostate Cancer.Urology · 2017Article
- Advances in hormonal therapies for hormone naïve and castration-resistant prostate cancers with or without previous chemotherapy.Experimental hematology & oncology · 2015Review
- Uptake carriers and oncology drug safety.Drug metabolism and disposition: the biological fate of chemicals · 2014Review
- Beyond castration-defining future directions in the hormonal treatment of prostate cancer.Hormones & cancer · 2012Review
- Article
- Article
- Use of testosterone replacement therapy in patients with prostate cancer.Current urology reports · 2011Review
- Efficacy and safety of docetaxel plus prednisolone chemotherapy for metastatic hormone-refractory prostate adenocarcinoma: single institutional study in Korea.Cancer research and treatment · 2010Article
- Phase 1 trial of high-dose exogenous testosterone in patients with castration-resistant metastatic prostate cancer.European urology · 2009Article
- Starving the addiction: new opportunities for durable suppression of AR signaling in prostate cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2009Review
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
purposeWe evaluated rapid androgen cycling in combination with docetaxel for men with progressive noncastrate prostate cancers. PATIENTS AND
methodsNoncastrate patients with <or= 6 months of hormone therapy were eligible. Cohort 1 (62 patients) received six 28-day cycles of docetaxel (75 mg/m(2)), leuprolide, and 7 days of topical testosterone. Cohort 2 (38 patients) received nine 21-day cycles of docetaxel (70 mg/m(2)), leuprolide, and 3 days of testosterone. The primary end point was the proportion of patients at 18 months who achieved noncastrate testosterone levels (> 150 ng/dL) and an undetectable prostate-specific antigen (PSA; <or= 0.05, <or= 0.5, or <or= 2.0 ng/mL with prior prostatectomy, radiation therapy, or no definitive therapy, respectively). Cytochrome P450 3A4 (CYP3A4) activity and docetaxel pharmacokinetics were evaluated.
resultsA higher proportion of patients achieved the undetectable PSA outcome at 18 months in cohort 2 relative to cohort 1 (13% v 0%). The 16% incidence of febrile neutropenia was higher than that observed in patients was castration-resistant disease, which may have been related to a 50% reduction in overall docetaxel clearance in the noncastrate group. There was no alteration in CYP3A4 activity (P = .87) or docetaxel clearance (P = .88) between cycles.
conclusionThe undetectable PSA end point allows for a rapid screening of interventions for further study. Increasing the number of docetaxel cycles after a shorter period of testosterone repletion, and a longer duration of testosterone depletion, increased the proportion of men who achieved an undetectable PSA. The higher-than-expected incidence of febrile neutropenia may have been related to the reduced overall docetaxel clearance in patients with noncastrate versus castrate testosterone levels.
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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.