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

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03964337
• Collaborator: Exelixis (Industry)
• Enrollment: 3
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is a prospective, randomized, open-label, phase II trial of cabozantinib in subjects with untreated, high risk prostate cancer undergoing radical prostatectomy. This multicenter study will enroll 30 subjects. Duke is the lead site for this trial. There will be a second site selected TBD.

Patients will be assigned (first 9 subjects only) or randomized 2:1 to either: (1) cabozantinib 40 mg by mouth daily for 4 weeks, followed by a 2 week drug washout period before prostatectomy (n = 20), or (2) immediate prostatectomy within 12 weeks of registration (n = 10). The first 9 subjects (6 subjects assigned to cabozantinib treatment, 3 subjects assigned to immediate prostatectomy) will constitute the Safety Lead-In Cohort, which will be only accrued at Duke. After six subjects have received cabozantinib and completed the 57-85 day safety visit without triggering a stopping rule, subjects may be accrued at the ex-Duke site.

The primary goal is to compare pathologic apoptotic indices (cleaved caspase-3) in prostatectomy specimens from patients who undergo immediate prostatectomy (controls) versus those who receive with cabozantinib followed by prostatectomy. The secondary objective is to conduct immune phenotypic profiling on the peripheral blood and tumor microenvironment in prostatectomy specimens from both groups. A statistical analysis will be used to compare the apoptotic indices between the two groups.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Prostate Cancer Adenocarcinoma; Non-Metastatic	Drug: Cabozantinib; Procedure: Radical Prostatectomy	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Phase II, Open-Label Randomized Study of Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer (SPARC)
• Actual Study Start Date: Mar 17, 2020
• Actual Primary Completion Date: Jun 4, 2021
• Actual Study Completion Date: Jun 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cabozantinib Followed by Prostatectomy (Arm A) Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.	Drug: Cabozantinib; Cabozantinib 40 mg by mouth daily for 4 weeks.; Other Names: Cabometyx ; Procedure: Radical Prostatectomy; Radical prostatectomy as part of routine medical care.
Active Comparator: Immediate Prostatectomy (Arm B) Control group will receive an immediate prostatectomy.	Procedure: Radical Prostatectomy; Radical prostatectomy as part of routine medical care.

Outcome Measures

Primary Outcome Measures

1. Apoptotic Index in Prostatectomy Specimens From Patients Who Undergo Immediate Prostatectomy (Arm B) Versus Those Treated With Cabozantinib Followed by Prostatectomy (Arm A) [At prostatectomy (Arm A: Day 43, Arm B: Day 1)]

   Apoptotic index as measured by cleaved caspase-3 levels in tumor tissue

Secondary Outcome Measures

1. Immune Phenotyping of Myeloid-derived Suppressor Cells (MDSCs) [Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1]

   Percentage of MDSCs in peripheral blood and tumor tissue

2. Immune Phenotyping of Neutrophils [Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1]

   Percentage of neutrophils in peripheral blood and tumor tissue

3. Immune Phenotyping of M1 Macrophages [Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1]

   Percentage of M1 macrophages in peripheral blood and tumor tissue

4. Immune Phenotyping of M2 Macrophages [Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1]

   Percentage of M2 macrophages in peripheral blood and tumor tissue

5. Immunohistochemical (IHC) Analysis of CD8+ [At prostatectomy (Arm A: Day 43, Arm B: Day 1)]

   Percentage of CD8+ positive cells in tumor tissue

6. Immunohistochemical (IHC) Analysis of Programmed Death Ligand-1 (PD-L1) [At prostatectomy (Arm A: Day 43, Arm B: Day 1)]

   Percentage of PD-L1 positive cells in tumor tissue

7. Immunohistochemical (IHC) Analysis of Cytotoxic T-lymphocyte-associated Protein 4 (CTLA-4) [At prostatectomy (Arm A: Day 43, Arm B: Day 1)]

   Percentage of CTLA-4 positive cells in tumor tissue

8. Immunohistochemical (IHC) Analysis of Interleukin-1 Receptor Antagonist (IL-1RA) [At prostatectomy (Arm A: Day 43, Arm B: Day 1)]

   Percentage of IL-1RA positive cells in tumor tissue

9. Description of the Neutrophil Chemotactic Factor CXCL12 [At prostatectomy (Arm A: Day 43, Arm B: Day 1)]

   Percentage of neutrophil chemotactic factor CXCL12 positive cells in tumor tissue

10. Description of the Neutrophil Chemotactic Factor HMGB1 [At prostatectomy (Arm A: Day 43, Arm B: Day 1)]

    Percentage of neutrophil chemotactic factor HMGB1 positive cells in tumor tissue

11. Description of the MDSC-promoting Cytokine CCL5 [At prostatectomy (Arm A: Day 43, Arm B: Day 1)]

    Percentage of MDSC-promoting cytokine CCL5 positive cells in tumor tissue

12. Description of the MDSC-promoting Cytokine CCL12 [At prostatectomy (Arm A: Day 43, Arm B: Day 1)]

    Percentage of MDSC-promoting cytokine CCL12 positive cells in tumor tissue

13. Description of the MDSC-promoting Cytokine CD40 [At prostatectomy (Arm A: Day 43, Arm B: Day 1)]

    Percentage of MDSC-promoting cytokine CD40 cells in tumor tissue

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male, age ≥ 18 years old.

2. ECOG performance status of 0 or 1

3. Histologic evidence of adenocarcinoma of the prostate who are deemed candidates for curative radical prostatectomy.

4. Planned robotic or laparoscopic prostatectomy technique.

5. Low risk for conversion to open prostatectomy, in the opinion of the treating surgeon.

6. Intermediate-high or high risk, clinically localized disease by the following criteria:

• Prostate cancer in at least 2 cores with a Gleason score ≥ 7 (4+3 or 3+4) in at least 1 of those cores.

• No definite evidence of metastasis, in the opinion of the investigator.

1. Adequate organ function as defined by the following criteria within 14 days prior to first dose of study treatment:

• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 x local laboratory upper limit of normal (ULN)

• Total serum bilirubin ≤1.5 x ULN, (for subjects with Gilbert's disease ≤ 3 x ULN)

• Absolute neutrophil count (ANC) ≥1500/L without granulocyte colony-stimulating factor support.

• White blood cell count ≥ 2500/mm3

• Serum albumin ≥ 2.8 g/dl

• Platelets ≥100,000/mm3

• Hemoglobin ≥9.0 g/dL

• Serum calcium ≤12.0 mg/dL

• Serum creatinine ≤ 2.0 x ULN or calculated creatinine clearance ≥ 30mL/min.

• Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol).

1. Written Authorization for Use and Release of Health and Research Study Information (HIPAA authorization per institutional requirements)

2. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.

3. Willing/able to adhere to the prohibitions and restrictions specified in this protocol.

4. Agrees to use a condom (even men with vasectomies) and another effective method of birth control if subject is having sex with a woman who is pregnant or a woman of childbearing potential while on study drug and for 4 months following the last dose of study drug.

Exclusion Criteria:

1. Prior treatment for prostate cancer.

2. Major surgery or radiation therapy within 4 weeks of Day 1 on study.

3. Planned radiation therapy until at least 4 weeks after prostatectomy.

4. NCI CTCAE v4.0 grade 3 hemorrhage within 4 weeks of Day 1 on study.

5. Prothrombin time (PT)/INR or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory ULN within 14 days before Day 1 on study (Arm A subjects only) or within 14 days of the completion of screening (Arm B subjects only).

6. Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel). However, low-dose aspirin for cardio protection is allowed (per local applicable guidelines).

7. History of or known metastatic prostate cancer.

8. QTcf interval > 500 msec on baseline EKG.

9. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

1. Cardiovascular disorders:

2. Symptomatic congestive heart failure (CHF) New York Heart Association Class 3 or 4, unstable angina pectoris, ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2. coronary/peripheral artery bypass graft (CABG), within 6 months prior to screening.

1. Stroke (including transient ischemic attack [TIA]), cerebrovascular accident (CVA), myocardial infarction (MI), or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism (PE)) within 6 months prior to screening.

1. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:

2. Evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.

1. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose.

Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose.

1. Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose.

2. Serious non-healing wound/ulcer/bone fracture. e. Other clinically significant disorders that would preclude safe study participation.

1. Hypertension that cannot be controlled by medications (>140/90 mm Hg despite optimal medical therapy).

2. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.

3. Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.

4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

5. Inability to swallow tablets.

6. Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• Exelixis

Investigators

• Principal Investigator: Michael Harrison, MD, Duke Cancer Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 1, 2021

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03964337
• Other Study ID Numbers: Pro00101042
• First Posted: May 28, 2019
• Last Update Posted: Jun 29, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	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)
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

Baseline Characteristics

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)	Total
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 Participants	3	0	3
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.47 (8.40)	62.47 (8.40)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 NaN
Male	3 100%	3 Infinity
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 NaN
Not Hispanic or Latino	3 100%	3 Infinity
Unknown or Not Reported	0 0%	0 NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN
Asian	0 0%	0 NaN
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN
Black or African American	0 0%	0 NaN
White	3 100%	3 Infinity
More than one race	0 0%	0 NaN
Unknown or Not Reported	0 0%	0 NaN
Region of Enrollment (Count of Participants)
United States	3 100%	3 Infinity

Outcome Measures

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)
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)

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

2. Secondary Outcome

Title	Immune Phenotyping of Myeloid-derived Suppressor Cells (MDSCs)
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

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

3. Secondary Outcome

Title	Immune Phenotyping of Neutrophils
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

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

4. Secondary Outcome

Title	Immune Phenotyping of M1 Macrophages
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

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

5. Secondary Outcome

Title	Immune Phenotyping of M2 Macrophages
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

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

6. Secondary Outcome

Title	Immunohistochemical (IHC) Analysis of CD8+
Description	Percentage of CD8+ positive cells in tumor tissue
Time Frame	At prostatectomy (Arm A: Day 43, Arm B: Day 1)

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

7. Secondary Outcome

Title	Immunohistochemical (IHC) Analysis of Programmed Death Ligand-1 (PD-L1)
Description	Percentage of PD-L1 positive cells in tumor tissue
Time Frame	At prostatectomy (Arm A: Day 43, Arm B: Day 1)

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

8. Secondary Outcome

Title	Immunohistochemical (IHC) Analysis of Cytotoxic T-lymphocyte-associated Protein 4 (CTLA-4)
Description	Percentage of CTLA-4 positive cells in tumor tissue
Time Frame	At prostatectomy (Arm A: Day 43, Arm B: Day 1)

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

9. Secondary Outcome

Title	Immunohistochemical (IHC) Analysis of Interleukin-1 Receptor Antagonist (IL-1RA)
Description	Percentage of IL-1RA positive cells in tumor tissue
Time Frame	At prostatectomy (Arm A: Day 43, Arm B: Day 1)

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

10. Secondary Outcome

Title	Description of the Neutrophil Chemotactic Factor CXCL12
Description	Percentage of neutrophil chemotactic factor CXCL12 positive cells in tumor tissue
Time Frame	At prostatectomy (Arm A: Day 43, Arm B: Day 1)

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

11. Secondary Outcome

Title	Description of the Neutrophil Chemotactic Factor HMGB1
Description	Percentage of neutrophil chemotactic factor HMGB1 positive cells in tumor tissue
Time Frame	At prostatectomy (Arm A: Day 43, Arm B: Day 1)

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

12. Secondary Outcome

Title	Description of the MDSC-promoting Cytokine CCL5
Description	Percentage of MDSC-promoting cytokine CCL5 positive cells in tumor tissue
Time Frame	At prostatectomy (Arm A: Day 43, Arm B: Day 1)

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

13. Secondary Outcome

Title	Description of the MDSC-promoting Cytokine CCL12
Description	Percentage of MDSC-promoting cytokine CCL12 positive cells in tumor tissue
Time Frame	At prostatectomy (Arm A: Day 43, Arm B: Day 1)

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

14. Secondary Outcome

Title	Description of the MDSC-promoting Cytokine CD40
Description	Percentage of MDSC-promoting cytokine CD40 cells in tumor tissue
Time Frame	At prostatectomy (Arm A: Day 43, Arm B: Day 1)

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Cabozantinib Followed by Prostatectomy (Arm A)	Immediate Prostatectomy (Arm B)
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.
Measure Participants	0	0

Adverse Events

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)
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)
Serious Adverse Events
	Cabozantinib Followed by Prostatectomy (Arm A)		Immediate Prostatectomy (Arm B)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Cabozantinib Followed by Prostatectomy (Arm A)		Immediate Prostatectomy (Arm B)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		0/0 (NaN)
Blood and lymphatic system disorders
Anemia	1/3 (33.3%)		0/0 (NaN)
Gastrointestinal disorders
Abdominal pain	2/3 (66.7%)		0/0 (NaN)
Constipation	3/3 (100%)		0/0 (NaN)
Diarrhea	1/3 (33.3%)		0/0 (NaN)
Nausea	1/3 (33.3%)		0/0 (NaN)
General disorders
Fatigue	2/3 (66.7%)		0/0 (NaN)
Pain	1/3 (33.3%)		0/0 (NaN)
Hepatobiliary disorders
Hepatobiliary disorders - Other	1/3 (33.3%)		0/0 (NaN)
Investigations
Alanine aminotransferase increased	1/3 (33.3%)		0/0 (NaN)
Aspartate aminotransferase increased	1/3 (33.3%)		0/0 (NaN)
Investigations - Other	1/3 (33.3%)		0/0 (NaN)
Neutrophil count decreased	1/3 (33.3%)		0/0 (NaN)
Platelet count decreased	1/3 (33.3%)		0/0 (NaN)
Renal and urinary disorders
Bladder spasm	1/3 (33.3%)		0/0 (NaN)
Urinary incontinence	2/3 (66.7%)		0/0 (NaN)
Reproductive system and breast disorders
Erectile dysfunction	1/3 (33.3%)		0/0 (NaN)
Skin and subcutaneous tissue disorders
Dry skin	1/3 (33.3%)		0/0 (NaN)
Hair color changes	1/3 (33.3%)		0/0 (NaN)
Skin and subcutaneous tissue disorders - Other	2/3 (66.7%)		0/0 (NaN)
Surgical and medical procedures
Surgical and medical procedures - Other	1/3 (33.3%)		0/0 (NaN)
Vascular disorders
Hypertension	1/3 (33.3%)		0/0 (NaN)
Hypotension	1/3 (33.3%)		0/0 (NaN)

Limitations/Caveats

Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B).

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.