Radical Prostatectomy for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate Cancer+3 MoreRadical Prostatectomy - Procedure
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial studies how well antiandrogen therapy works with or without axitinib before surgery in treating patients with prostate cancer.

Eligible Conditions
  • Prostate Cancer
  • Metastatic Cancer in Lymph Node
  • Prostate Cancer (Stage III)
  • Prostate Cancer (Stage IV)

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 months after surgery

12 months after surgery
Participants Progression-free 12 months after surgery

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm II (antiandrogen therapy, surgery)
1 of 2
Arm I (antiandrogen therapy, axitinib, surgery)
1 of 2

Active Control

Experimental Treatment

73 Total Participants · 2 Treatment Groups

Primary Treatment: Radical Prostatectomy · No Placebo Group · Phase 2

Arm I (antiandrogen therapy, axitinib, surgery)Experimental Group · 4 Interventions: Regional Lymph Node Dissection, Radical Prostatectomy, Antiandrogen Therapy, Axitinib · Intervention Types: Procedure, Procedure, Drug, Drug
Arm II (antiandrogen therapy, surgery)ActiveComparator Group · 3 Interventions: Regional Lymph Node Dissection, Radical Prostatectomy, Antiandrogen Therapy · Intervention Types: Procedure, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radical Prostatectomy
2005
Completed Phase 2
~4520
Antiandrogen Therapy
2015
Completed Phase 1
~10
Axitinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months after surgery

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,290 Total Patients Enrolled
90 Trials studying Prostate Cancer
27,535 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,083 Previous Clinical Trials
41,141,429 Total Patients Enrolled
537 Trials studying Prostate Cancer
502,396 Patients Enrolled for Prostate Cancer
Amado J Zurita SaavedraPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have non-bulky (< 5 cm) regional pelvic or distant lymphadenopathy visualized on computed tomography (CT)/magnetic resonance imaging (MRI) scan; lymph node biopsy is required if < 2.
You have an Eastern Cooperative Oncology Group performance status of 2 or better.
Lymph node biopsy or lymph node dissection demonstrating lymph node metastasis by prostate cancer.
You have received prior hormonal therapy for at least 8 weeks.