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Hormone Therapy

Sunitinib + Hormone Therapy for Prostate Cancer

Phase 2

Waitlist Available

Led By Amado Zurita, MD

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

Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of >= 1,500/mm^3 and platelet count of >= 100,000/mm^3; hemoglobin >= 9.0g/dl; adequate hepatic function defined as a total bilirubin of <=1.5 mg/dl and AST/ALT <= 2 x the upper limit of normal; adequate renal function defined as serum creatinine <= 1.5 x the upper limits of normal or creatinine clearance >= 40cc/min (measured or calculated).

All patients must have one of the following high-risk features: clinical (c) T3 disease or Gleason 8-10 adenocarcinoma or cT2b-c and PSA >= 10 ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging system will be followed.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surgery following 3 months of therapy.

Awards & highlights

Study Summary

This trial is testing whether adding sunitinib to hormone therapy can better shrink or control the tumor before surgery.

Who is the study for?

This trial is for men with confirmed adenocarcinoma of the prostate that's considered removable by surgery. They must be at low risk for anesthesia during prostate removal, intend to have this surgery after therapy, and meet specific cancer severity criteria (like Gleason score 8-10). Participants need normal organ function and can't have had certain treatments or conditions like metastatic disease, recent heart issues, uncontrolled hypertension or diabetes.Check my eligibility

What is being tested?

The study tests if adding Sunitinib Malate to hormone-based castration before removing the prostate helps shrink/control the tumor. It involves a drug called Sunitinib Malate combined with hormonal therapy prior to radical prostatectomy—a surgical procedure to remove the prostate gland.See study design

What are the potential side effects?

Sunitinib Malate may cause side effects such as fatigue, diarrhea, skin discoloration, mouth sores, high blood pressure, bleeding events and potentially affect liver enzymes. Hormonal ablation can lead to hot flashes, reduced sexual desire and other hormone-related changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is advanced or very aggressive based on its size, PSA levels, and Gleason score.

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I am considered low risk for anesthesia and plan to have surgery to remove my prostate after initial treatment.

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I can carry out all my daily activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ surgery following 3 months of therapy.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~surgery following 3 months of therapy.

This trial's timeline: 3 weeks for screening, Varies for treatment, and surgery following 3 months of therapy. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Inverse PCR

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sunitinib + Hormonal Ablation Before ProstatectomyExperimental Treatment3 Interventions

Sunitinib Malate 25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles. LHRH Agonist intramuscular injection either monthly for 3 months or in a single 3-month dose. Radical prostatectomy after completion of Sunitinib and LHRH agonist.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sunitinib Malate

2008

Completed Phase 3

~3070

Radical Prostatectomy

2005

Completed Phase 2

~4550

LHRH Agonist

2013

Completed Phase 2

~130

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,809 Total Patients Enrolled

41 Trials studying Prostate Cancer

12,305 Patients Enrolled for Prostate Cancer

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,717 Total Patients Enrolled

95 Trials studying Prostate Cancer

29,676 Patients Enrolled for Prostate Cancer

Amado Zurita, MDPrincipal InvestigatorM.D. Anderson Cancer Center

5 Previous Clinical Trials

326 Total Patients Enrolled

2 Trials studying Prostate Cancer

4 Patients Enrolled for Prostate Cancer

Media Library

LHRH Agonist (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00329043 — Phase 2

Prostate Cancer Research Study Groups: Sunitinib + Hormonal Ablation Before Prostatectomy

Prostate Cancer Clinical Trial 2023: LHRH Agonist Highlights & Side Effects. Trial Name: NCT00329043 — Phase 2

LHRH Agonist (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00329043 — Phase 2

Frequently Asked Questions

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

Are there currently any recruitment opportunities for this research endeavor?

"This investigation is not currently recruiting volunteers. It was initially listed on May 1st 2006 and the last edit took place on December 6th 2022. If you are looking for alternative trials, there are 1326 studies focusing on prostate cancer that are actively accepting patients as well as 99 investigations involving Sunitinib Malate seeking participants."

Answered by AI

Are there any historical precedents for research into Sunitinib Malate?

"Currently, the number of active clinical trials employing Sunitinib Malate is 99 with 35 in Phase 3. In Duarte, California alone there are several trials being conducted; however, across all 9218 medical centres worldwide that offer this treatment the total amount of said experiments reaches into the double digits."

Answered by AI

What is the aggregate participation rate for this experiment?

"The clinical trial is not an active recruitment at the present time. It was initially listed on May 1st 2006 and its last update occurred December 6th 2022. Those looking for other research opportunities may want to explore 1326 trials recruiting prostate cancer patients or 99 studies enrolling people in Sunitinib Malate programs."

Answered by AI

What potential adverse effects are associated with Sunitinib Malate?

"Sunitinib Malate received a score of 2 on our evaluation, as it is currently undergoing Phase 2 trials. This implies that while there are signs suggesting the drug's safety, no data can be found to support its effectiveness."

Answered by AI

What therapeutic purpose does Sunitinib Malate typically fulfill?

"Sunitinib Malate is the most common form of treatment for symptom recurrence and has seen success in treating thyroid cancers, metastatic pancreatic neuroendocrine tumors, and advanced prostate cancer."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy

2006. "Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00329043.

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