Cabozantinib in Men With Castration-Resistant Prostate Cancer

Phase 2

Terminated

• Conditions: Castration-resistant Prostate Cancer; Stage III Prostate Cancer; Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer
• Interventions: Drug: Cabozantinib

• Registration Number: NCT01703065
• Lead Sponsor: University of Washington

Brief Summary

This pilot clinical trial studies cabozantinib in treating men with castration-resistant prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description

Primary Outcome Measure:

1. Change in urinary N-telopeptide (uNTX) from baseline to after 6 weeks of treatment with cabozantinib in men with non-metastatic CRPC.

Secondary Outcome Measures:

2. Changes in serum markers of bone metabolism from baseline to after 6 weeks of treatment with cabozantinib. Markers of bone metabolism in blood include bone specific alkaline phosphatase, alkaline phosphatase, LDH.

3. Changes in biomarker expression in bone biopsy samples. To include MET, AKT, FASN and VEGFR2 expression and phosphorylation status (activation) in osteoblasts/osteoclasts and prostate cancer cells. Will also include changes in markers of apoptosis, proliferation, and angiogenesis.

OUTLINE:

Patients receive cabozantinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.

Study Timeline

• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-05
• Study First Posted: 2012-10-10
• Study Start: 2013-06-18
• Primary Completion: 2015-02-02
• Study Completion: 2015-09-18
• Disposition First Submitted: 2017-10-16
• Disposition First Submitted QC: 2017-11-25
• Disposition First Posted: 2017-12-05
• Results First Submitted: 2018-08-03
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-06
• Last Update Submitted: 2018-11-06
• Results First Posted: 2018-12-04
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cabozantinib in metastatic CRPC	Cabozantinib	Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.
Cabozantinib in non-metastatic CRPC	Cabozantinib	Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Change in Urinary N-telopeptide (uNTX) as a Marker of Bone Metabolism in Non-metastatic Patients	Baseline and 6 weeks	Median percent change in Urinary N-Telopeptide from baseline compared to after 6 weeks of treatment with Cabozantinib in patients with non-metastatic prostate cancer.

Secondary Outcome Measures

Name	Time	Method
Change in Alkaline Phosphatase as a Marker of Bone Metabolism	Baseline, 6 weeks	Median percent change in Alkaline Phosphatase from baseline compared to after 6 weeks of treatment with Cabozantinib.
Change in Lactic Acid Dehydrogenase (LDH) as a Marker of Bone Metabolism	Baseline and at 6 weeks	Median percent change in Lactic Acid Dehydrogenase (LDH) from baseline compared to after 6 weeks of treatment with Cabozantinib.
Change in Bone Specific Alkaline Phosphatase as a Marker of Bone Metabolism	Baseline and at 6 weeks	Median percent change in Bone Specific Alkaline Phosphatase from baseline compared to after 6 weeks of treatment with Cabozantinib.
Changes in Biomarker Expression in Bone Biopsy Samples	Baseline and at 6 weeks	To include MET, AKT, FASN and VEGFR2 expression and phosphorylation status (activation) in osteoblasts/osteoclasts and prostate cancer cells. Will also include changes in markers of apoptosis, proliferation, and angiogenesis.

Trial Locations

Locations (1)

Seattle Cancer Care Alliance/University of Washington; 🇺🇸 Seattle, Washington, United States