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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 below

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I can do most of my daily activities but not heavy physical work.

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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:

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My cancer is confirmed as small cell or sarcomatoid through a biopsy.

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I have had chemotherapy, experimental treatments, or over 8 weeks of hormone therapy for prostate cancer.

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My high blood pressure is not well controlled.

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I expect to need a major surgery during the study.

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I have had serious abdominal issues, untreated bone fractures, or major wounds.

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I am allergic to or have previously used axitinib.

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I have certain heart, lung, liver, or immune system conditions.

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I had another type of cancer but was treated successfully and have been cancer-free for 3 years.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after surgery for reporting.

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