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Tyrosine Kinase Inhibitor

Radical Prostatectomy for Prostate Cancer (SPARC Trial)

Phase 2
Waitlist Available
Led By Michael Harrison, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up arm a: screening, day 29, day 43, day 57-85; arm b: screening, day 1
Awards & highlights

SPARC Trial Summary

Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer

Eligible Conditions
  • Prostate Cancer
  • Non-Metastatic

SPARC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~arm a: screening, day 29, day 43, day 57-85; arm b: screening, day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and arm a: screening, day 29, day 43, day 57-85; arm b: screening, day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apoptotic Index in Prostatectomy Specimens From Patients Who Undergo Immediate Prostatectomy (Arm B) Versus Those Treated With Cabozantinib Followed by Prostatectomy (Arm A)
Secondary outcome measures
Description of the MDSC-promoting Cytokine CCL12
Description of the MDSC-promoting Cytokine CCL5
Description of the MDSC-promoting Cytokine CD40
+10 more

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250
74%
Hot flashes
71%
Fatigue
44%
Anemia
38%
Hyperglycemia
26%
AST increase
26%
Hypertension
26%
Lipase increase
24%
ALT increase
24%
Dry skin
21%
Rash
18%
ACTH increase
18%
Cholesterol high
15%
Amylase increase
15%
Dizziness
12%
Memory impairment
12%
White blood cell decrease
12%
Constipation
12%
Lymphocyte count decrease
9%
Myalgia
9%
Paresthesia
9%
Weight loss
9%
Arthralgia
9%
Hypothyrodism
9%
LDH increase
6%
Personality change
6%
Erectile dysfunction
6%
Headache
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Anxiety
3%
Atrial fibrillation
3%
Bruising
3%
Anorexia
3%
Hypercalcemia
3%
Dehydration
3%
TSH increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Arm A (LHRHa, Apalutamide)

SPARC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cabozantinib Followed by Prostatectomy (Arm A)Experimental Treatment2 Interventions
Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.
Group II: Immediate Prostatectomy (Arm B)Active Control1 Intervention
Control group will receive an immediate prostatectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1080
Radical Prostatectomy
2005
Completed Phase 2
~4550

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,420,066 Total Patients Enrolled
42 Trials studying Prostate Cancer
96,791 Patients Enrolled for Prostate Cancer
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,548 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,293 Patients Enrolled for Prostate Cancer
Michael Harrison, MDPrincipal InvestigatorDuke Cancer Institute
6 Previous Clinical Trials
127 Total Patients Enrolled
2 Trials studying Prostate Cancer
78 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer
2020. "Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03964337.
~1 spots leftby Apr 2025
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