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Hormone Therapy
Antiandrogen Therapy +/− Axitinib for Prostate Cancer
Phase 2
Waitlist Available
Led By Amado J Zurita Saavedra
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 2 or better
Patients must be regarded as acceptable surgical risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the pre-surgical therapy
Must not have
Patients with biopsy-proven small cell or sarcomatoid histology
Patients who have had prior chemotherapy, experimental agents for prostate cancer, or more than 8 weeks of prior hormone therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how well antiandrogen therapy works with or without axitinib before surgery in treating patients with prostate cancer.
Who is the study for?
Men with untreated prostate cancer that has spread to lymph nodes may join this trial. They must be fit for surgery, have a good performance status (ECOG 2 or better), and agree to use contraception. Excluded are those who've had prior chemotherapy, more than 8 weeks of hormone therapy, certain other health issues, or are on drugs affecting the study medication.
What is being tested?
The trial is testing if antiandrogen therapy alone or combined with Axitinib is more effective before surgery in patients with prostate cancer that has possibly spread to lymph nodes. It's unknown whether adding Axitinib improves outcomes.
What are the potential side effects?
Antiandrogen therapy can cause hot flashes, fatigue, and sexual dysfunction. Axitinib might lead to high blood pressure, fatigue, nausea, diarrhea and could increase the risk of bleeding or affect liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most of my daily activities but not heavy physical work.
Select...
I am considered a good candidate for prostate surgery and plan to have it after pre-surgery treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer is confirmed as small cell or sarcomatoid through a biopsy.
Select...
I have had chemotherapy, experimental treatments, or over 8 weeks of hormone therapy for prostate cancer.
Select...
My high blood pressure is not well controlled.
Select...
I expect to need a major surgery during the study.
Select...
I have had serious abdominal issues, untreated bone fractures, or major wounds.
Select...
I am allergic to or have previously used axitinib.
Select...
I have certain heart, lung, liver, or immune system conditions.
Select...
I had another type of cancer but was treated successfully and have been cancer-free for 3 years.
Select...
My cancer has spread to my bones or other areas beyond the original site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Participants Progression-free 12 months after surgery
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (antiandrogen therapy, axitinib, surgery)Experimental Treatment4 Interventions
Patients receive antiandrogen therapy per standard care and axitinib PO BID for 4 months. Patients then undergo radical prostatectomy and pelvic lymph node dissection.
Group II: Arm II (antiandrogen therapy, surgery)Active Control3 Interventions
Patients receive antiandrogen therapy per standard care for 4 months and then undergo radical prostatectomy and pelvic lymph node dissection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radical Prostatectomy
2005
Completed Phase 2
~4550
Antiandrogen Therapy
2015
Completed Phase 1
~10
Axitinib
2020
Completed Phase 2
~3050
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,172 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,928 Total Patients Enrolled
Amado J Zurita SaavedraPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have consulted with both a surgeon and a medical oncologist before agreeing to participate.I do not have stomach or digestion problems that affect how my body uses medicine.I can do most of my daily activities but not heavy physical work.My cancer is confirmed as small cell or sarcomatoid through a biopsy.I have had chemotherapy, experimental treatments, or over 8 weeks of hormone therapy for prostate cancer.I have an infection that could get worse with new treatments.My high blood pressure is not well controlled.I expect to need a major surgery during the study.I am allergic to or have previously used axitinib.I am considered a good candidate for prostate surgery and plan to have it after pre-surgery treatment.I have certain heart, lung, liver, or immune system conditions.My prostate cancer is considered operable after treatment, according to my urologist.My cancer's stage has been thoroughly assessed.I have had serious abdominal issues, untreated bone fractures, or major wounds.I had another type of cancer but was treated successfully and have been cancer-free for 3 years.I will need drugs that affect CYP3A4 enzymes.My cancer has spread to my bones or other areas beyond the original site.I have had hormone therapy for up to 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (antiandrogen therapy, surgery)
- Group 2: Arm I (antiandrogen therapy, axitinib, surgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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