Trial Outcomes & Findings for Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer (NCT NCT01385059)

Last Updated: 2023-03-07

Results Overview

The niche density is defined as the average number of VEGF receptor 1 (VEGFR1) clusters in 8 distinct 40X microscopic fields in the regional lymph nodes of patients. We will use a two sample student's T-test to compare the primary endpoint of pre-metastatic niche density in the patients treated with axitinib, as compared to the pre-metastatic niche density in the patients enrolled on the control arm.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

At the time of prostatectomy

Results posted on

2023-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Neoadjuvant Enzyme Inhibitor and Prostatectomy) Patients receive axitinib PO BID on days 1-28. Patients then undergo prostatectomy and pelvic lymph node dissection. Treatment continues in the absence of disease progression or unacceptable toxicity. axitinib: Given PO therapeutic conventional surgery: Undergo prostatectomy and pelvic lymph node dissection enzyme-linked immunosorbent assay: Correlative studies laboratory biomarker analysis: Correlative studies	Arm II (Surgery) Patients undergo prostatectomy and pelvic lymph node dissection at 5-6 weeks after biopsy confirmation of prostate cancer. therapeutic conventional surgery: Undergo prostatectomy and pelvic lymph node dissection enzyme-linked immunosorbent assay: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Study STARTED	4	7
Overall Study COMPLETED	4	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Neoadjuvant Enzyme Inhibitor and Prostatectomy) n=4 Participants Patients receive axitinib PO BID on days 1-28. Patients then undergo prostatectomy and pelvic lymph node dissection. Treatment continues in the absence of disease progression or unacceptable toxicity. axitinib: Given PO therapeutic conventional surgery: Undergo prostatectomy and pelvic lymph node dissection enzyme-linked immunosorbent assay: Correlative studies laboratory biomarker analysis: Correlative studies	Arm II (Surgery) n=7 Participants Patients undergo prostatectomy and pelvic lymph node dissection at 5-6 weeks after biopsy confirmation of prostate cancer. therapeutic conventional surgery: Undergo prostatectomy and pelvic lymph node dissection enzyme-linked immunosorbent assay: Correlative studies laboratory biomarker analysis: Correlative studies	Total n=11 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	60 years n=7 Participants	67 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	7 participants n=7 Participants	11 participants n=5 Participants
Clinical T stage Stage T1	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Clinical T stage Stage T2	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Pathologic T Stage Stage T2a/b	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Pathologic T Stage Stage T2c	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Pathologic T Stage Stage T3a/b	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Preoperative Gleason grade Gleason grade < 8	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Preoperative Gleason grade Gleason grade >= 8	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Baseline PSA Baseline PSA < 20 ng/mL	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Baseline PSA Unfavorable	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of prostatectomy

Population: Caution should be taken when drawing conclusions from these data as the target sample size needed per arm was not reached.

Outcome measures

Outcome measures
Measure	Arm I (Axitinib Followed by Surgery) n=4 Participants Patients receive Axitinib PO BID on days 1-28. Patients then undergo prostatectomy and pelvic lymph node dissection. Treatment continues in the absence of disease progression or unacceptable toxicity. Axitinib: Given PO Therapeutic conventional surgery: Undergo prostatectomy and pelvic lymph node dissection	Arm II (Surgery) n=7 Participants Patients undergo prostatectomy and pelvic lymph node dissection at 5-6 weeks after biopsy confirmation of prostate cancer. Therapeutic conventional surgery: Undergo prostatectomy and pelvic lymph node dissection
Pre-metastatic Niche Density	75.6 clusters/hpf Interval 34.3 to 79.4	62.5 clusters/hpf Interval 1.0 to 104.4

Adverse Events

Arm I (Neoadjuvant Enzyme Inhibitor and Prostatectomy)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm II (Surgery)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Sumanta Kumar Pal

City of Hope Medical Center

Phone: 626-359-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I (Neoadjuvant Enzyme Inhibitor and Prostatectomy) n=4 participants at risk Patients receive axitinib PO BID on days 1-28. Patients then undergo prostatectomy and pelvic lymph node dissection. Treatment continues in the absence of disease progression or unacceptable toxicity. axitinib: Given PO therapeutic conventional surgery: Undergo prostatectomy and pelvic lymph node dissection enzyme-linked immunosorbent assay: Correlative studies laboratory biomarker analysis: Correlative studies	Arm II (Surgery) n=7 participants at risk Patients undergo prostatectomy and pelvic lymph node dissection at 5-6 weeks after biopsy confirmation of prostate cancer. therapeutic conventional surgery: Undergo prostatectomy and pelvic lymph node dissection enzyme-linked immunosorbent assay: Correlative studies laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders 10002272-Anemia	50.0% 2/4 • Number of events 2 • From the initial treatment up to 60 weeks.	42.9% 3/7 • Number of events 3 • From the initial treatment up to 60 weeks.
Cardiac disorders 10040741-Sinus bradycardia	25.0% 1/4 • Number of events 1 • From the initial treatment up to 60 weeks.	0.00% 0/7 • From the initial treatment up to 60 weeks.
Gastrointestinal disorders 10000081-Abdominal pain	0.00% 0/4 • From the initial treatment up to 60 weeks.	14.3% 1/7 • Number of events 1 • From the initial treatment up to 60 weeks.
General disorders 10016256-Fatigue	0.00% 0/4 • From the initial treatment up to 60 weeks.	14.3% 1/7 • Number of events 1 • From the initial treatment up to 60 weeks.
General disorders 10033371-Pain	0.00% 0/4 • From the initial treatment up to 60 weeks.	14.3% 1/7 • Number of events 1 • From the initial treatment up to 60 weeks.
General disorders 10054482-Neck edema	0.00% 0/4 • From the initial treatment up to 60 weeks.	14.3% 1/7 • Number of events 1 • From the initial treatment up to 60 weeks.
Metabolism and nutrition disorders 10020639-Hyperglycemia	50.0% 2/4 • Number of events 2 • From the initial treatment up to 60 weeks.	28.6% 2/7 • Number of events 2 • From the initial treatment up to 60 weeks.
Metabolism and nutrition disorders 10020647-Hyperkalemia	25.0% 1/4 • Number of events 1 • From the initial treatment up to 60 weeks.	0.00% 0/7 • From the initial treatment up to 60 weeks.
Metabolism and nutrition disorders 10020949-Hypocalcemia	50.0% 2/4 • Number of events 2 • From the initial treatment up to 60 weeks.	28.6% 2/7 • Number of events 2 • From the initial treatment up to 60 weeks.
Metabolism and nutrition disorders 10021005-Hypoglycemia	0.00% 0/4 • From the initial treatment up to 60 weeks.	14.3% 1/7 • Number of events 1 • From the initial treatment up to 60 weeks.
Metabolism and nutrition disorders 10021018-Hypokalemia	25.0% 1/4 • Number of events 1 • From the initial treatment up to 60 weeks.	0.00% 0/7 • From the initial treatment up to 60 weeks.
Metabolism and nutrition disorders 10021038-Hyponatremia	25.0% 1/4 • Number of events 1 • From the initial treatment up to 60 weeks.	0.00% 0/7 • From the initial treatment up to 60 weeks.
Musculoskeletal and connective tissue disorders 10003988-Back pain	25.0% 1/4 • Number of events 1 • From the initial treatment up to 60 weeks.	0.00% 0/7 • From the initial treatment up to 60 weeks.
Musculoskeletal and connective tissue disorders 10065780-Muscle weakness left-sided	0.00% 0/4 • From the initial treatment up to 60 weeks.	14.3% 1/7 • Number of events 1 • From the initial treatment up to 60 weeks.
Nervous system disorders 10013573-Dizziness	0.00% 0/4 • From the initial treatment up to 60 weeks.	14.3% 1/7 • Number of events 1 • From the initial treatment up to 60 weeks.
Reproductive system and breast disorders 10036968-Prostatic pain	0.00% 0/4 • From the initial treatment up to 60 weeks.	14.3% 1/7 • Number of events 1 • From the initial treatment up to 60 weeks.
Reproductive system and breast disorders 10061461-Erectile dysfunction	25.0% 1/4 • Number of events 1 • From the initial treatment up to 60 weeks.	0.00% 0/7 • From the initial treatment up to 60 weeks.
Respiratory, thoracic and mediastinal disorders 10011224-Cough	25.0% 1/4 • Number of events 1 • From the initial treatment up to 60 weeks.	0.00% 0/7 • From the initial treatment up to 60 weeks.
Vascular disorders 10020772-Hypertension	25.0% 1/4 • Number of events 1 • From the initial treatment up to 60 weeks.	14.3% 1/7 • Number of events 1 • From the initial treatment up to 60 weeks.