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Hormone Therapy

Hormone Therapy + Radiation for Prostate Cancer

N/A

Waitlist Available

Led By Stanley Liauw, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial will compare quality of life and survival rates for patients receiving oral hormone therapy or standard of care.

Who is the study for?

Men aged 18+ with intermediate or high-risk prostate cancer who haven't had radical surgery, hormonal therapy, or certain other treatments for prostate cancer. They should have a life expectancy of at least 10 years and be able to give informed consent. Men with severe health issues like unstable angina, active infections needing IV antibiotics, liver problems, AIDS, or autoimmune diseases are excluded.Check my eligibility

What is being tested?

The trial is testing if oral hormone therapies (Bicalutamide, Dutasteride, Finasteride) plus radiation improve quality of life and survival rates compared to standard care in men with prostate cancer. It's looking at how well patients do on these drugs versus the usual treatment.See study design

What are the potential side effects?

Possible side effects from the hormone therapies may include breast tenderness/enlargement, hot flashes, reduced sex drive/erectile function; while radiation can cause fatigue, skin changes in treated area and urinary/bowel symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire

Secondary outcome measures

Percentage of Participants Free From Biochemical Failure

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oral Androgen TherapyExperimental Treatment4 Interventions

Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Finasteride

FDA approved

Radiation

2003

Completed Phase 3

~1020

Bicalutamide

FDA approved

Dutasteride

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,003 Previous Clinical Trials

819,675 Total Patients Enrolled

20 Trials studying Prostate Cancer

8,209 Patients Enrolled for Prostate Cancer

Stanley Liauw, MDPrincipal InvestigatorUniversity of Chicago

1 Previous Clinical Trials

17 Total Patients Enrolled

Media Library

Bicalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01342367 — N/A

Prostate Cancer Research Study Groups: Oral Androgen Therapy

Prostate Cancer Clinical Trial 2023: Bicalutamide Highlights & Side Effects. Trial Name: NCT01342367 — N/A

Bicalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01342367 — N/A

Frequently Asked Questions

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

What health concerns can Dutasteride alleviate?

"Dutasteride is routinely used to treat bladder outlet obstruction, as well as benign prostatic hyperplasia and benign prostatic hypertrophy."

Answered by AI

Is this research the inaugural endeavor of its type?

"Presently, 54 clinical trials for Dutasteride are ongoing over 857 cities and 30 countries. AstraZeneca first initiated research on the drug in 2000 with a Phase 3 study involving 600 participants; since then, an additional 353 studies have been carried out."

Answered by AI

How many participants are being included in this clinical trial?

"This research endeavour is not currently taking on any new patients. The trial was first posted in December 2010 and the information has been updated most recently at the end of September 2021. If you are interested, there are 1321 trials with open enrollment for prostate cancer and 54 studies utilizing Dutasteride that require volunteers to participate."

Answered by AI

Have other experiments demonstrated the efficacy of Dutasteride?

"Currently, there are 54 active Dutasteride studies with 20 in Phase 3. Notably, although the majority of these clinical trials for Dutasteride originate from Springfield, Missouri, 3710 other locations across the globe are running similar tests."

Answered by AI

Is recruitment for this medical trial still open?

"Evidence from clinicaltrials.gov suggests that this trial is not presently recruiting for participants, as the study was initially posted on December 17th 2010 and last updated September 30th 2021. However, there are 1,375 other trials actively searching for patients at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

2010. "Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01342367.

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