Trial Outcomes & Findings for Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) (NCT NCT04631744)

Last Updated: 2026-05-01

Results Overview

Radiographic progression will be assessed based on PCWG-modified RECIST 1.1 criteria for soft-tissue lesions and protocol-specific criteria for bone lesions. Progressive disease (PD) for soft-tissue lesions is defined as an increase ≥ 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started, or the appearance of one or more new lesions, or the appearance of new lesions. Progressive disease (PD) criteria for bone lesions is assessing whether there are either "no new lesions" or "new lesions", which will be confirmed on a second scan performed 6 or more weeks later. Radiographic progress-free survival (rPFS) is defined as time from start of treatment to minimum of radiographic progression.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

From initiation of treatment to minimum of radiographic progression, approximately 6 months.

Results posted on

2026-05-01

Participant Flow

1 subject withdrew after being registered but before starting treatment.

Participant milestones

Participant milestones
Measure	Cabozantinib Each participant received cabozantinib, 40 mg PO daily.
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cabozantinib Each participant received cabozantinib, 40 mg PO daily.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cabozantinib n=3 Participants Each participant received cabozantinib, 40 mg PO daily.
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=14 Participants
Age, Categorical >=65 years	2 Participants n=14 Participants
Sex: Female, Male Female	0 Participants n=14 Participants
Sex: Female, Male Male	3 Participants n=14 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants
Race (NIH/OMB) Asian	1 Participants n=14 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants
Race (NIH/OMB) Black or African American	0 Participants n=14 Participants
Race (NIH/OMB) White	1 Participants n=14 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=14 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=14 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants

PRIMARY outcome

Timeframe: From initiation of treatment to minimum of radiographic progression, approximately 6 months.

Population: 1 participant withdrew after being registered but before starting treatment

Outcome measures

Outcome measures
Measure	Cabozantinib n=3 Participants Each participant received cabozantinib, 40 mg PO daily.
Median Radiographic Progression-free Survival (rPFS) Using Kaplan-Meier Methodology	2.8 Months Interval 2.0 to There were insufficient number of patients enrolled on this study to generate meaningful outcome measures. Consequently, the upper bound of the confidence interval was not estimable due to an insufficient number of events.

SECONDARY outcome

Timeframe: From initiation of treatment to minimum of radiographic progression, at approximately 6 months after start of treatment.

Population: 1 subject was not evaluable for response and 1 withdrew prior to treatment initiation.

Number of men with meaningful decrease in PSA based on modified PCWG3 criteria.

Outcome measures

Outcome measures
Measure	Cabozantinib n=2 Participants Each participant received cabozantinib, 40 mg PO daily.
Change in Prostate Specific Antigen (PSA)	0 Participants

SECONDARY outcome

Timeframe: Patients will be followed every 12 weeks up to 2 years after completion of study

Population: 1 subject withdrew before treatment initiation

Overall survival will be captured through in-clinic or telephone contact with patients.

Outcome measures

Outcome measures
Measure	Cabozantinib n=3 Participants Each participant received cabozantinib, 40 mg PO daily.
Overall Survival (OS)	8.2 Months Interval 2.8 to There were insufficient number of patients enrolled on this study to generate meaningful outcome measures. Consequently, the upper bound of the confidence interval was not estimable due to an insufficient number of events.

SECONDARY outcome

Timeframe: From initiation of treatment to minimum of radiographic progression, at approximately 6 months after start of treatment.

Population: 1 subject withdrew before treatment initiation

Modified response evaluation criteria in solid tumors (RECIST) criteria is used to determine complete response (CR) or partial response (PR).

Outcome measures

Outcome measures
Measure	Cabozantinib n=3 Participants Each participant received cabozantinib, 40 mg PO daily.
Number of Patients With a Tumor Response	0 Participants

SECONDARY outcome

Timeframe: From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.

Adverse events based on NCI-CTCAE Version 5 guidelines

Outcome measures

Outcome measures
Measure	Cabozantinib n=4 Participants Each participant received cabozantinib, 40 mg PO daily.
Number of Adverse Events	58 Adverse Events

Adverse Events

Cabozantinib

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cabozantinib n=4 participants at risk Each participant received cabozantinib, 40 mg PO daily.
Hepatobiliary disorders Hepatic Failure	25.0% 1/4 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Renal and urinary disorders Pyleonephritis	25.0% 1/4 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
General disorders Generalized Weakness	25.0% 1/4 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.

Other adverse events

Other adverse events
Measure	Cabozantinib n=4 participants at risk Each participant received cabozantinib, 40 mg PO daily.
General disorders Pain	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Renal and urinary disorders Urinary hesitancy	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Blood and lymphatic system disorders Anemia	50.0% 2/4 • Number of events 2 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
General disorders Non-cardiac chest pain	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Gastrointestinal disorders Dry mouth	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Gastrointestinal disorders Dyspepsia	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Gastrointestinal disorders Cramping	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Investigations Alanine aminotransferase increased	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Investigations Alkaline phosphatase increased	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Investigations Blood bilirubin increased	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Investigations Creatinine increased	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Investigations Proteinuria	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Metabolism and nutrition disorders Hypoglycemia	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Musculoskeletal and connective tissue disorders Bone pain	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Cardiac disorders Sinus tachycardia	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Musculoskeletal and connective tissue disorders Difficulty ambulating from the swelling in legs	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Renal and urinary disorders Hematuria	50.0% 2/4 • Number of events 3 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Renal and urinary disorders Urinary incontinence	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
General disorders Fatigue	100.0% 4/4 • Number of events 4 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
General disorders Edema Limbs	50.0% 2/4 • Number of events 2 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
General disorders Malaise	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Infections and infestations Macular rash	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Infections and infestations Cold sores	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Nervous system disorders Somnolence	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Psychiatric disorders Insomnia	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Reproductive system and breast disorders Pelvic pain	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Chest congestion	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Voice alteration	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Skin and subcutaneous tissue disorders Suprapubic swelling	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Skin and subcutaneous tissue disorders Petechiae	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Skin and subcutaneous tissue disorders Diffuse itchiness	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Vascular disorders Hot flashes	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Vascular disorders Headache	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.
Vascular disorders Acute Pulmonary Embolism	25.0% 1/4 • Number of events 1 • From the time of signing consent through their End of Treatment visit, which is 30 days after the date of the last dose of cabozantinib treatment, approximately 12 months.

Additional Information

Dr. David Nanus

Weill Cornell Medicine

Phone: 646-962-2072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place