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VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy

Study acronym: PREVENT-GU
StatusRecruiting
PhasePhase 2/3
Started2024-11-04
View on ClinicalTrials.gov ↗

Amendment history

2025-07-08
minor
Study Status v4
Re-verified, no change to tracked fields
2025-01-24
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-02→2026-10
Completion date2026-02→2026-10
Start dateestimated 2024-02→confirmed 2024-11-04
Study sites0→1
2023-10-30
minor
Study Status v2
Primary completion date2025-09→2026-02
Completion date2025-09→2026-02
Start date2023-09→2024-02
2023-08-13
minor
Study Status, Outcome Measures v1
Secondary endpoints4 entries, revised
Adherence to the study intervention, assessed as the proportion of patients taking the study medication >80% of days taken during the study period,
Primary endpoints1 entry, revised
Feasibility of enrollment, assesed by the number of patients accrued per month
2023-06-16
minor
Original filing
Patients with genitourinary cancers (ex: bladder, testicular, kidney) are at high risk of developing blood clots if they receive systemic therapy (ex: chemotherapy, immunotherapy). Blood clots cause pain, may require hospitalization and invasive testing, and in some cases cause death. In fact, blood clots are one of the leading causes of death in patients with cancer. Furthermore, patients who develop a blood clot require medication to thin the blood for a prolonged (sometimes indefinite) period of time, and this can disrupt other important cancer treatments. Studies have shown that using low dose blood thinners to prevent blood clots during systemic therapy is effective in some patients with cancer. However very few patients in these studies had genitourinary cancers, therefore physicians in Canada are not sure if recommending blood thinners to patients with genitourinary cancers is useful or safe. Safety is a primary concern because blood thinners may cause bleeding, and patients with genitourinary cancers may have higher risk of bleeding than patients with other types of cancer. The investigators hypothesize that blood thinners are effective and safe for reducing blood clots in patients with genitourinary cancers. The objective of this study is to determine if a large clinical trial testing the effectiveness and safety of low dose blood thinners for preventing blood clots in patients with genitourinary cancers receiving systemic therapy is feasible.
Trial Details
NCT Number NCT05920343
Lead Sponsor Ottawa Hospital Research Institute
Collaborators: Canadian Institutes of Health Research (CIHR), Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, Kidney Cancer Research Network of Canada
Conditions Venous Thromboembolism, Urologic Cancer
Enrollment 120 participants
Start Date 2024-11-04
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-07-10