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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months after surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participants Progression-free 12 months after surgery

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,248 Total Patients Enrolled

96 Trials studying Prostate Cancer

29,740 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,926,000 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

Amado J Zurita SaavedraPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Antiandrogen Therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01409200 — Phase 2

Prostate Cancer Research Study Groups: Arm II (antiandrogen therapy, surgery), Arm I (antiandrogen therapy, axitinib, surgery)

Prostate Cancer Clinical Trial 2023: Antiandrogen Therapy Highlights & Side Effects. Trial Name: NCT01409200 — Phase 2

Antiandrogen Therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01409200 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is Radical Prostatectomy a secure procedure for people?

"The safety rating of Radical Prostatectomy in this study is 2, as there has been preliminary data indicating a degree of safety but no supporting evidence for efficacy."

Answered by AI

What other experiments involving Radical Prostatectomy have been conducted thus far?

"Currently, there are 48 Radical Prostatectomy trials running in various stages of completion; four have already reached Phase 3. In Houston, Texas alone, several sites are conducting these studies while 1038 locations worldwide are participating in the research."

Answered by AI

Are there any remaining vacancies for the medical trial?

"Judging from the information supplied by clinicaltrials.gov, this medical trial is not presently accepting participants. Initially posted on March 26th 2012 and recently updated on August 17th 2022, this study is no longer recruiting but there are over 4000 other trials that currently require patients to join them."

Answered by AI

Is this experimental research the inaugural of its kind?

"Since 2011, Radical Prostatectomy has been studied extensively with the first trial sponsored by Pfizer. Following its Phase 2 drug approval from an initial 39-patient study, there are now 48 active investigations involving this medical intervention taking place in 386 cities and 30 countries worldwide."

Answered by AI

What is the enrollment capacity for this experiment?

"Unfortunately, this clinical trial is no longer recruiting. Initially posted on March 26th 2012 and last edited August 17th 2022; those looking for alternative trials can browse through the 4264 studies seeking patients with lymphatic metastasis or the 48 trials enrolling participants who have undergone Radical Prostatectomy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis

2012. "Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01409200.

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