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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964337
Recruitment Status : Terminated (Poor accrual.)
First Posted : May 28, 2019
Results First Posted : June 29, 2022
Last Update Posted : June 29, 2022
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Prostate Cancer
Prostate Cancer Adenocarcinoma
Non-Metastatic
Interventions Drug: Cabozantinib
Procedure: Radical Prostatectomy
Enrollment 3
Recruitment Details  
Pre-assignment Details Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B).
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Period Title: Overall Study
Started 3 0
Completed 3 0
Not Completed 0 0
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B) Total
Hide Arm/Group Description

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Total of all reporting groups
Overall Number of Baseline Participants 3 0 3
Hide Baseline Analysis Population Description
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 0 participants 3 participants
62.47  (8.40) 62.47  (8.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
Female
0
   0.0%
0
   0.0%
Male
3
 100.0%
3
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
3
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
3
 100.0%
3
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 0 participants 3 participants
3
 100.0%
3
 100.0%
1.Primary Outcome
Title Apoptotic Index in Prostatectomy Specimens From Patients Who Undergo Immediate Prostatectomy (Arm B) Versus Those Treated With Cabozantinib Followed by Prostatectomy (Arm A)
Hide Description Apoptotic index as measured by cleaved caspase-3 levels in tumor tissue
Time Frame At prostatectomy (Arm A: Day 43, Arm B: Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Immune Phenotyping of Myeloid-derived Suppressor Cells (MDSCs)
Hide Description Percentage of MDSCs in peripheral blood and tumor tissue
Time Frame Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Immune Phenotyping of Neutrophils
Hide Description Percentage of neutrophils in peripheral blood and tumor tissue
Time Frame Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Immune Phenotyping of M1 Macrophages
Hide Description Percentage of M1 macrophages in peripheral blood and tumor tissue
Time Frame Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Immune Phenotyping of M2 Macrophages
Hide Description Percentage of M2 macrophages in peripheral blood and tumor tissue
Time Frame Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Immunohistochemical (IHC) Analysis of CD8+
Hide Description Percentage of CD8+ positive cells in tumor tissue
Time Frame At prostatectomy (Arm A: Day 43, Arm B: Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Immunohistochemical (IHC) Analysis of Programmed Death Ligand-1 (PD-L1)
Hide Description Percentage of PD-L1 positive cells in tumor tissue
Time Frame At prostatectomy (Arm A: Day 43, Arm B: Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Immunohistochemical (IHC) Analysis of Cytotoxic T-lymphocyte-associated Protein 4 (CTLA-4)
Hide Description Percentage of CTLA-4 positive cells in tumor tissue
Time Frame At prostatectomy (Arm A: Day 43, Arm B: Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Immunohistochemical (IHC) Analysis of Interleukin-1 Receptor Antagonist (IL-1RA)
Hide Description Percentage of IL-1RA positive cells in tumor tissue
Time Frame At prostatectomy (Arm A: Day 43, Arm B: Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Description of the Neutrophil Chemotactic Factor CXCL12
Hide Description Percentage of neutrophil chemotactic factor CXCL12 positive cells in tumor tissue
Time Frame At prostatectomy (Arm A: Day 43, Arm B: Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Description of the Neutrophil Chemotactic Factor HMGB1
Hide Description Percentage of neutrophil chemotactic factor HMGB1 positive cells in tumor tissue
Time Frame At prostatectomy (Arm A: Day 43, Arm B: Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Description of the MDSC-promoting Cytokine CCL5
Hide Description Percentage of MDSC-promoting cytokine CCL5 positive cells in tumor tissue
Time Frame At prostatectomy (Arm A: Day 43, Arm B: Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Description of the MDSC-promoting Cytokine CCL12
Hide Description Percentage of MDSC-promoting cytokine CCL12 positive cells in tumor tissue
Time Frame At prostatectomy (Arm A: Day 43, Arm B: Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Description of the MDSC-promoting Cytokine CD40
Hide Description Percentage of MDSC-promoting cytokine CD40 cells in tumor tissue
Time Frame At prostatectomy (Arm A: Day 43, Arm B: Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description:

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Adverse Event Reporting Description Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
 
Arm/Group Title Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Hide Arm/Group Description

Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.

Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

Control group will receive an immediate prostatectomy.

Radical Prostatectomy: Radical prostatectomy as part of routine medical care.

All-Cause Mortality
Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/0 
Hide Serious Adverse Events
Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cabozantinib Followed by Prostatectomy (Arm A) Immediate Prostatectomy (Arm B)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   0/0 
Blood and lymphatic system disorders     
Anemia   1/3 (33.33%)  0/0 
Gastrointestinal disorders     
Abdominal pain   2/3 (66.67%)  0/0 
Constipation   3/3 (100.00%)  0/0 
Diarrhea   1/3 (33.33%)  0/0 
Nausea   1/3 (33.33%)  0/0 
General disorders     
Fatigue   2/3 (66.67%)  0/0 
Pain   1/3 (33.33%)  0/0 
Hepatobiliary disorders     
Hepatobiliary disorders - Other   1/3 (33.33%)  0/0 
Investigations     
Alanine aminotransferase increased   1/3 (33.33%)  0/0 
Aspartate aminotransferase increased   1/3 (33.33%)  0/0 
Investigations - Other   1/3 (33.33%)  0/0 
Neutrophil count decreased   1/3 (33.33%)  0/0 
Platelet count decreased   1/3 (33.33%)  0/0 
Renal and urinary disorders     
Bladder spasm   1/3 (33.33%)  0/0 
Urinary incontinence   2/3 (66.67%)  0/0 
Reproductive system and breast disorders     
Erectile dysfunction   1/3 (33.33%)  0/0 
Skin and subcutaneous tissue disorders     
Dry skin   1/3 (33.33%)  0/0 
Hair color changes   1/3 (33.33%)  0/0 
Skin and subcutaneous tissue disorders - Other   2/3 (66.67%)  0/0 
Surgical and medical procedures     
Surgical and medical procedures - Other   1/3 (33.33%)  0/0 
Vascular disorders     
Hypertension   1/3 (33.33%)  0/0 
Hypotension   1/3 (33.33%)  0/0 
Indicates events were collected by systematic assessment
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Harrison, M.D.
Organization: Duke University
Phone: 919-668-8108
EMail: michael.harrison@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03964337    
Other Study ID Numbers: Pro00101042
First Submitted: May 23, 2019
First Posted: May 28, 2019
Results First Submitted: June 3, 2022
Results First Posted: June 29, 2022
Last Update Posted: June 29, 2022