18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical Benefit Rate From Cabozantinib (XL184)Primary· Baseline to 12 weeks after starting therapy
Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria.
Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) \>=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease.
Group
Value
95% CI
Treatment (Cabozantinib)
10
Change in Number of Circulating Tumor Cells (CTC) in Response to CabozantinibSecondary· Baseline and 12 weeks
Change in number of CTC from baseline at 12 weeks
Group
Value
95% CI
Treatment (Cabozantinib)
53.2
± 217.8
Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor CellsSecondary· 12 weeks
This is to provide a measure of feasibility using NanoVelcro to measure RNA in circulating tumor cells (CTC)
Group
Value
95% CI
Treatment (Cabozantinib)
16
Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) ConcentrationSecondary· 12 weeks
Mean change from baseline in levels of HGF and VEGF
Group
Value
95% CI
Treatment (Cabozantinib) HGF Levels
-322.96
± 1981.19
Treatment (Cabozantinib) VEGF Levels
191.1
± 302.1
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4)Secondary· Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks.
Each cycle is 28 days. Safety and tolerability was defined as related grade 3-4 AEs of doses of cabozantinib below 100 mg daily using common terminology criteria for adverse events (CTCAE)
AST increased
Group
Value
95% CI
Treatment (Cabozantinib)
4
Alkaline phosphatase increased
Group
Value
95% CI
Treatment (Cabozantinib)
2
Anemia
Group
Value
95% CI
Treatment (Cabozantinib)
1
Corneal Epithelial Defect
Group
Value
95% CI
Treatment (Cabozantinib)
1
Dehydration
Group
Value
95% CI
Treatment (Cabozantinib)
1
Diarrhea
Group
Value
95% CI
Treatment (Cabozantinib)
1
GGT increased
Group
Value
95% CI
Treatment (Cabozantinib)
1
Hematuria
Group
Value
95% CI
Treatment (Cabozantinib)
1
Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of DeathSecondary· From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks.
This is a feasibility outcome to assess ability to measure protein content in large oncosomes in this population.
Group
Value
95% CI
Treatment (Cabozantinib)
12
Adverse events — posted to ClinicalTrials.gov
Time frame: From signed consent up to 30 days after last treatment.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Cabozantinib)
Serious: 14/17 (82%)
Deaths: —
Serious adverse events (11 terms)
Reaction
System
Treatment (Cabozantinib)
Anemia
Blood and lymphatic system disorders
—
Nausea
Gastrointestinal disorders
—
Chest Pain- Cardiac
Cardiac disorders
—
Cholecystitis
Hepatobiliary disorders
—
Confusion
Psychiatric disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Fever
General disorders
—
Hematuria
Renal and urinary disorders
—
Keratitis
Eye disorders
—
Rectal fistula
Gastrointestinal disorders
—
Retinal detachment
Eye disorders
—
Other adverse events (119 terms — click to expand)
This research study is being done to measure the clinical benefit associated with cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant prostate cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07293351 — A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Caboz
· Phase 1, PHASE2
· recruiting
NCT07187869 — Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell
· Phase 1
· not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
· Phase 3
· recruiting
NCT06900595 — Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescent
· Phase 2
· recruiting
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno)
· recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
· Phase 2
· recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer
· Phase 2
· recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris
· Phase 2
· recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate
· Phase 2, PHASE3
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Edwin Posadas, MD
Last refreshed: 27 September 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01834651.