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1 Study Matches

Site for 22-061 Relugolix Versus Leuprolide in Patients with Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV)

The purpose of this research study is to compare and see if medications used in ADT treatment, either relugolix or leuprolide acetate, lower the risk of cardiovascular events in patients with prostate cancer. You (or your caregiver) will be asked to complete questionnaires electronically (such as computer, tablet, or smartphone) and/or share information via phone calls every three months until the end of your participation in the study. You will receive the study medications for treatment (either relugolix or leuprolide acetate)

Participants will be required to complete questionnaires electronically (such as computer, tablet, or smartphone) and/or share information via phone calls every three months until the end of your participation in the study. You will receive the study medications for treatment (either relugolix or leuprolide acetate)

$150 per year

Yes
 
Megan Wheelden
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05605964
SITE00001315
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Inclusion Criteria:
Has voluntarily signed and dated the informed consent form prior to baseline visit;
Is a male and 18 years of age or older on the day of signing and dating the informed consent form;
Patient has sufficient cognitive function in the investigator’s opinion to complete the questionnaires and other activities related to the study
Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
Is, in the opinion of the investigator, a candidate for at least 1 year of continuous ADT for the management of prostate cancer with one of the following clinical disease state presentations:Evidence of biochemical (prostate-specific antigen
Exclusion Criteria:
Any significant cardiovascular conditions per the investigator within 1 month before study entry
Any major cardiovascular or cerebrovascular procedures planned within 1 month after enrollment;
Patients with QT interval corrected for heart rate (QTc) determined using Fridericia’s formula (QTcF; QTcF = QT/[R-R interval {RR}^0.33]) > 470 msec within 6 months of screening
Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) at the time of screening
Previously received GnRH receptor agonist
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,