VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy

NCT05920343 | Recruiting Phase 2 DMC

• 1 other identifier: PGU2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Thromboembolism; Urologic Cancer

Keywords

Genitourinary Cancer; Venous Thromboembolism; Systemic Therapy; Thromboprophylaxis

Outcome Measures

Primary Outcomes (1)

• Feasibility of enrollment, assesed by the number of patients accrued per month

  The primary outcome of this Pilot Trial is feasibility of enrollment. Feasibility will be measured by the average number of patients accrued per month.

  Enrollment

Secondary Outcomes (4)

• Adherence to the study intervention, assessed as the proportion of patients taking the study medication >80% of days taken during the study period,

  During 180 days of study intervention

• Recruitment rate

  Enrollment

• VTE incidence

  During 180 days of study intervention

• Bleeding incidence

  During 180 days of study intervention

Other Outcomes (4)

• VTE-related death

  During 180 days of study intervention

• Overall survival

  During 180 days of study intervention

• Health-related Quality of Life assessed using the EQ-5D-5L Score

  During 180 days of study intervention

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Participants receiving study drug (Rivaroxaban)

Drug: Rivaroxaban 10 MG

Control

PLACEBO COMPARATOR

Participants receiving matched placebo

Other: Placebo control

Interventions

Rivaroxaban 10 MG DRUG

The intervention in the experimental arm will be rivaroxaban, 10 mg PO once daily (prophylactic dosing) for 180 days after the start of systemic therapy or until one of the primary study outcomes occurs (VTE or major bleeding).

Also known as: Xarelto

Rivaroxaban

Placebo control OTHER

Identical to Rivaroxaban intervention except participants will receive a matched placebo instead of the study drug

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are starting systemic therapy for active GU cancer (bladder, testis, ureter/renal pelvis, kidney, urethral, penile) except for prostate cancer.
• Age ≥ 18
• Eligible systemic therapies include chemotherapy, targeted therapies (tyrosine kinase inhibitors and antiangiogenic therapy), and immunotherapies.
• Patients must be initiating systemic therapy with a minimum planned treatment duration of 8 weeks.

You may not qualify if:

• Anticoagulation (prophylactic or therapeutic dosing) required for another indication for entire duration of study
• Known allergies to rivaroxaban
• Concomitant use of dual antiplatelet therapy (two antiplatelet medications oncomitantly)
• Ongoing refractory bleeding that may be exacerbated by rivaroxaban.
• Concomitant use of strong inducers or inhibitors of CYP3A4 or glycoprotein-P (known interaction with rivaroxaban).
• Severe renal insufficiency (Creatinine clearance \<30 mL/min (defined by Cockcroft-Gault))
• Severe liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis)
• Thrombocytopenia \< 50 x 109/L
• Life expectancy under 6 months.
• Pregnancy (if child bearing age under 50 and sexually active, documentation of use of effective contraception or negative B- HCG is required)
• Patient is breastfeeding or lactating
• History of condition at increased bleeding risk including, but not limited to:
• cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the previous 4 weeks.
• Chronic hemorrhagic disorder
• Inability to adhere to protocol or obtain consent.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network: collaborator
• Kidney Cancer Research Network of Canada: collaborator

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Urologic Neoplasms; Urogenital Neoplasms

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Luke T Lavallee, MDCM MSc FRCSC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luke T Lavallee, MDCM MSc FRCSC

CONTACT

613-737-8899; lulavallee@toh.ca

David J Yachnin, MSc

CONTACT

613-798-5555; dyachnin@toh.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind placebo-controlled study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 27, 2023
• Study Start: November 4, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)