Trial reportEuropean urology2019
Cabozantinib Versus Mitoxantrone-prednisone in Symptomatic Metastatic Castration-resistant Prostate Cancer: A Randomized Phase 3 Trial with a Primary Pain Endpoint.
Trial report in European urology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01522443 (A Phase 3, Randomized, Double-blind, Controlled Trial of Cabozantinib), which is not on this map. Cited by 42 papers, 3 of them syntheses that pooled it.
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.
A Phase 3, Randomized, Double-blind, Controlled Trial of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer
Who cites it
42 citing papers in PubMed, 3 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Cabozantinib and thromboembolism in patients with cancer: a systematic review, meta-analysis, and retrospective study.Blood advances · 2026Pooled it
- Patient-reported outcome domains in multiple myeloma randomized controlled trials and association with survival outcomes.Annals of hematology · 2024Pooled it
- Harnessing the patient voice in prostate cancer research: Systematic review on the use of patient-reported outcomes in randomized controlled trials to support clinical decision-making.Cancer medicine · 2020Pooled it
- Efficacy and safety of mitoxantrone hydrochloride liposome injection in Chinese patients with advanced breast cancer: a randomized, open-label, active-controlled, single-center, phase II clinical trial.Investigational new drugs · 2022Trial
- Comparison of weekly and daily recall of pain as an endpoint in a randomized phase 3 trial of cabozantinib for metastatic castration-resistant prostate cancer.Clinical trials (London, England) · 2021Trial
- Cabozantinib plus docetaxel and prednisone in metastatic castration-resistant prostate cancer.BJU international · 2021Trial
- Assessment of Adverse Events From the Patient Perspective in a Phase 3 Metastatic Castration-Resistant Prostate Cancer Clinical Trial.JAMA oncology · 2020Trial
- Quality of patient-reported outcome reporting and related trial characteristics in randomized controlled trials of cancer pain: A systematic review based on the CONSORT-PRO extension.Asia-Pacific journal of oncology nursing · 2026Review
- C-MET tyrosine kinase receptor: mechanisms, clinical applications and future perspectives in cancer therapy.Signal transduction and targeted therapy · 2026Review
- Article
- The HGF/MET Axis in Advanced Prostate Cancer: From Context-Dependent Biology to Biomarker-Driven Therapeutic Strategies.Cancers · 2026Review
- Efficacy and Safety of Ifosfamide and Mesna in Metastatic Castration-Resistant Prostate Cancer after Taxane-Based Chemotherapy and Novel Hormonal Therapy Failure.Cancer research and treatment · 2026Article
- Patient-reported oral adverse events during cancer chemotherapy: longitudinal evaluation using patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) and concordance with clinician assessments.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Article
- Review
- Targeting the tumor microenvironment, a new therapeutic approach for prostate cancer.Prostate cancer and prostatic diseases · 2025Review
- The NET-DNA-CCDC25 inhibitor di-Pal-MTO suppresses tumor progression and promotes the innate immune response.Cellular & molecular immunology · 2025Article
- P3-GemOx as a novel immunochemotherapy candidate in NK/T-cell lymphoma management.Frontiers in medicine · 2025Article
- Targeting multiple receptor tyrosine kinases with sitravatinib: A Phase 1b study in advanced renal cell carcinoma and castrate-resistant prostate cancer.Investigational new drugs · 2024Article
- PSMA-Targeted 2-Deoxyglucose-Based Dendrimer Nanomedicine for the Treatment of Prostate Cancer.Biomacromolecules · 2024Article
- PSMA-targeted dendrimer as an efficient anticancer drug delivery vehicle for prostate cancer.Nanoscale · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 19 institutions in 4 countries.
Funding
Abstract
backgroundBone metastases in patients with metastatic castration-resistant prostate cancer (mCRPC) are associated with debilitating pain and functional compromise.
objectiveTo compare pain palliation as the primary endpoint for cabozantinib versus mitoxantrone-prednisone in men with mCRPC and symptomatic bone metastases using patient-reported outcome measures. DESIGN, SETTING, AND
participantsA randomized, double-blind phase 3 trial (COMET-2; NCT01522443) in men with mCRPC and narcotic-dependent pain from bone metastases who had progressed after treatment with docetaxel and either abiraterone or enzalutamide.
interventionCabozantinib 60mg once daily orally versus mitoxantrone 12mg/m OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was pain response at week 6 confirmed at week 12 (≥30% decrease from baseline in patient-reported average daily worst pain score via the Brief Pain Inventory without increased narcotic use). The planned sample size was 246 to achieve ≥90% power. RESULTS AND LIMITATIONS: Enrollment was terminated early because cabozantinib did not demonstrate a survival benefit in the companion COMET-1 trial. At study closure, 119 participants were randomized (cabozantinib: N=61; mitoxantrone-prednisone: N=58). Complete pain and narcotic use data were available at baseline, week 6, and week 12 for 73/106 (69%) patients. There was no significant difference in the pain response with cabozantinib versus mitoxantrone-prednisone: the proportions of responders were 15% versus 17%, a -2% difference (95% confidence interval: -16% to 11%, p=0.8). Barriers to accrual included pretreatment requirements for a washout period of prior anticancer therapy and a narcotic optimization period to maximize analgesic dosing.
conclusionsCabozantinib treatment did not demonstrate better pain palliation than mitoxantrone-prednisone in heavily pretreated patients with mCRPC and symptomatic bone metastases. Future pain-palliation trials should incorporate briefer timelines from enrollment to treatment initiation. PATIENT SUMMARY: Cabozantinib was not better than mitoxantrone-prednisone for pain relief in patients with castration-resistant prostate cancer and debilitating pain from bone metastases.
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What OpenQuestion holds
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.