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Gonadotropin-Releasing Hormone (GnRH) Agonist

Arm 1 (leuprolide) for Prostate Adenocarcinoma

Phase 2

Waitlist Available

Led By Shang-Jui Wang, MD, PhD

Research Sponsored by Ohio State University Comprehensive Cancer Center

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 up to 6 months

Awards & highlights

Study Summary

This trial compares the effects of two different treatments, relugolix and leuprolide, on heart health and performance in prostate cancer patients. Androgen deprivation therapy (ADT) is commonly

Who is the study for?

This trial is for men with prostate cancer who need hormone therapy and haven't started it yet. They should be fit enough for cardiac tests, willing to answer questionnaires, and give blood samples. Specific details on who can or cannot participate are not provided here.Check my eligibility

What is being tested?

The study compares Relugolix and Leuprolide's effects on heart health in prostate cancer patients undergoing hormone therapy. It includes MRI scans, physical tests, biospecimen collection, and uses a contrast agent during the process.See study design

What are the potential side effects?

Potential side effects of Relugolix and Leuprolide may include impacts on heart function due to hormonal changes from the treatment. Other side effects specific to these drugs are not detailed here.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Physiologic alterations in cardiopulmonary function - Maximal rate of oxygen consumption

Physiologic alterations in cardiopulmonary function - Myocardial perfusion

Secondary outcome measures

Changes in body composition

Functional tests of strength and balance using 10-meter walk time

Functional tests of strength and balance using Grip strength

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 (relugolix)Experimental Treatment5 Interventions

Patients receive definitive therapy for prostate cancer with ADT (relugolix orally once daily for a total of 6 months) in the absence of disease progression or unacceptable toxicity and definitive radiotherapy within 90 days of starting ADT. Patients receive gadolinium-based contrast intravenously (IV) and undergo exercise-stress cardiac MRI perfusion and comprehensive exercise physiology testing before starting ADT and at 6 months after starting ADT. Patients also undergo blood and urine sample collection throughout the study, as well as completion of quality-of-life questionnaires.

Group II: Arm 1 (leuprolide)Experimental Treatment5 Interventions

Patients receive definitive therapy for prostate cancer with ADT (leuprolide via injection once every 3 months, for a total of 6 months) in the absence of disease progression or unacceptable toxicity and definitive radiotherapy within 90 days of starting ADT. Patients receive gadolinium-based contrast intravenously (IV) and undergo exercise-stress cardiac MRI perfusion and comprehensive exercise physiology testing before starting ADT and at 6 months after starting ADT. Patients also undergo blood and urine sample collection throughout the study, as well as completion of quality-of-life questionnaires.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Relugolix

2016

Completed Phase 3

~5360

Leuprolide

2008

Completed Phase 4

~18970

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sumitomo Pharmaceuticals AmericaIndustry Sponsor

1 Previous Clinical Trials

80 Total Patients Enrolled

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,097 Total Patients Enrolled

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,804 Total Patients Enrolled

Frequently Asked Questions

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

Is the enrollment for this study currently available to prospective participants?

"The investigation, as per clinicaltrials.gov, is not currently in need of participants. It was initially published on April 1st, 2024 and last modified on March 19th, 2024. Despite its closure to new entrants, there are a substantial number of 1324 alternative trials actively seeking volunteers at present."

Answered by AI

Is the use of Arm 1 (leuprolide) considered safe for individuals?

"In this Phase 2 trial, Arm 1 involving leuprolide is rated as a 2 for safety by our experts at Power. This score signifies existing data on safety but lacks evidence of efficacy."

Answered by AI

What are the specific goals and objectives of this research study?

"The primary objective in this investigation, to be evaluated within a period of up to half a year, is the assessment of physiological changes in cardiopulmonary function specifically focusing on the maximal rate at which oxygen is consumed. The secondary endpoints encompass an evaluation of quality of life by employing two different instruments: EuroQol-5-Dimension 5-level (EQ-5D-5L) and Patient-Reported Outcomes Measurement Information System (PROMIS). Additionally, functional assessments involving strength and balance will be conducted using the Timed Up-and-Go test protocol where participants are timed while performing specific tasks related to mobility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer

Shang-Jui Wang, MD, PhD 2024. "Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06330805.