ArticleThe Journal of urology2010
A phase I clinical study of high dose ketoconazole plus weekly docetaxel for metastatic castration resistant prostate cancer.
Article in The Journal of urology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
18 citing papers in PubMed, 33 citations in OpenAlex.
- A Combined Chemoinformatics- and Machine Learning-Based Approach Identifies Chlormidazole as a Drug Repurposing Candidate against Aggressive Prostate Cancer.Journal of medicinal chemistry · 2026Article
- Metabolic Targets in CRC: The Emerging Role of Cytochrome P450 Inhibitors.Current pharmaceutical design · 2025Review
- Article
- Repurposing antifungal drugs for cancer therapy.Journal of advanced research · 2023Review
- Lung cancer cells survive epidermal growth factor receptor tyrosine kinase inhibitor exposure through upregulation of cholesterol synthesis.FASEB bioAdvances · 2020Article
- Inhibition of proliferation and migration of melanoma cells by ketoconazole andOncology letters · 2019Article
- Effects of Ketoconazole on ACTH-Producing and Non-ACTH-Producing Neuroendocrine Tumor Cells.Hormones & cancer · 2019Article
- The role of ketoconazole in current prostate cancer care.Nature reviews. Urology · 2018Review
- Review
- PSMA targeted docetaxel-loaded superparamagnetic iron oxide nanoparticles for prostate cancer.Colloids and surfaces. B, Biointerfaces · 2016Article
- Review
- Medical strategies for treatment of castration resistant prostate cancer (CRPC) docetaxel resistant.Cancer biology & therapy · 2012Review
- The prognostic factors of effective ketoconazole treatment for metastatic castration-resistant prostate cancer: who can benefit from ketoconazole therapy?Asian journal of andrology · 2012Article
- Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures.Journal of hematology & oncology · 2012Review
- Redefining hormone sensitive disease in advanced prostate cancer.Advances in urology · 2012Article
- Overcoming chemotherapy resistance in prostate cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2011Article
- CYP17 inhibitors for prostate cancer therapy.The Journal of steroid biochemistry and molecular biology · 2011Review
- Chemotherapy and its evolving role in the management of advanced prostate cancer.Asian journal of andrologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 1 country.
Funding
Abstract
purposeThis phase I study of high dose ketoconazole and docetaxel was designed against castration resistant prostate cancer to determine the maximum tolerated doses, side effects, and pharmacokinetic interaction of co-administered docetaxel and ketoconazole. MATERIALS AND
methodsPatients with metastatic castration resistant prostate cancer received weekly docetaxel for 3 of every 4 weeks plus daily ketoconazole. Pharmacokinetic studies were performed on day 1 (docetaxel alone) and day 16 (after ketoconazole).
resultsThe study enrolled 42 patients at 9 different dose levels. The combination regimens investigated included docetaxel weekly, increasing from 5 to 43 mg/m(2), with starting doses of 600, 800 or 1,200 mg ketoconazole daily. Decreases in prostate specific antigen of 50% or greater were seen in 62% of patients. Of 25 patients with soft tissue disease 7 (28%) had a partial response. Median overall survival was 22.8 months and was significantly greater in docetaxel naïve patients than in patients pretreated with docetaxel (36.8 vs 10.3 months, p = 0.0001). The most frequently observed adverse events were anemia, edema, fatigue, diarrhea, nausea, sensory neuropathy and elevated liver function tests. The fractional change in docetaxel clearance correlated significantly with ketoconazole exposure (p <0.01). Concomitant ketoconazole increased docetaxel exposure 2.6-fold with 1,200 mg daily, 1.6-fold with 800 mg daily and approximately 1.3 to 1.5-fold with 600 mg daily.
conclusionsCombination regimens using 600 mg ketoconazole daily were fairly well tolerated and the maximum tolerated dose of docetaxel was 32 mg/m(2). Results suggest that the combination has significant antitumor activity in castration resistant prostate cancer. The long survival in the docetaxel naïve cohort warrants additional, larger trials of docetaxel with ketoconazole or possibly CYP17A1 inhibitors such as abiraterone.
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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.