Rivaroxaban for Urinary Tract Cancer

(PREVENT-GU Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Luke T Lavallee, MDCM MSc FRCSC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Anticoagulants, Dual antiplatelets

Disqualifiers: Severe renal insufficiency, Severe liver disease, Thrombocytopenia, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain blood thinners, dual antiplatelet therapy, or medications that strongly interact with rivaroxaban. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Rivaroxaban for treating urinary tract cancer?

Rivaroxaban has been shown to be effective in preventing blood clots in cancer patients, as seen in studies where it was compared to other blood thinners like enoxaparin. While this doesn't directly show its effectiveness for urinary tract cancer, it suggests Rivaroxaban can be beneficial in managing blood clot risks in cancer patients. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 18 with genitourinary cancers (like bladder or kidney cancer) except prostate cancer, who are starting systemic treatments like chemotherapy. They must be planning to undergo treatment for at least 8 weeks.

Inclusion Criteria

I am eligible for treatments like chemotherapy, targeted therapies, and immunotherapies.

I am starting a treatment that will last at least 8 weeks.

I am starting treatment for a urinary cancer, but not prostate cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Rivaroxaban or placebo during systemic therapy for genitourinary cancers

26 weeks

Regular visits for monitoring and pill counts

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to be monitored for long-term outcomes such as overall survival and quality of life

Long-term

Treatment Details

Interventions

• Rivaroxaban (Anticoagulant)

Trial Overview The study tests if a low dose of Rivaroxaban, a blood thinner, can safely prevent blood clots in patients receiving systemic therapy for genitourinary cancers compared to a placebo control.

Participant Groups

Group I: Rivaroxaban Experimental Treatment 1 Intervention

Participants receiving study drug (Rivaroxaban)

Group II: Control Placebo Group 1 Intervention

Participants receiving matched placebo

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ottawa Hospital Research Institute Ottawa, Canada

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute Lead Sponsor

Canadian Institutes of Health Research (CIHR) Collaborator

Kidney Cancer Research Network of Canada Collaborator

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. [2022] Patients with venous thromboembolism and cancer have a substantial risk of recurrent venous thromboembolism and bleeding during anticoagulant therapy. Although monotherapy with low-molecular-weight heparin is recommended in these patients, in clinical practice many patients with venous thromboembolism and cancer do not receive this treatment. We aimed to assess the efficacy and safety of a single-drug regimen with oral rivaroxaban compared with enoxaparin followed by vitamin K antagonists, in the subgroup of patients with cancer enrolled in the EINSTEIN-DVT and EINSTEIN-PE randomised controlled trials.

2. England pubmed.ncbi.nlm.nih.gov

Outcomes from a prospectively implemented protocol using apixaban after robot-assisted radical cystectomy. [2023] To compare the safety and efficacy of oral apixaban with that of injectable enoxaparin after robot-assisted radical cystectomy (RARC) for venous thromboembolism (VTE) thromboprophylaxis.

3. United States pubmed.ncbi.nlm.nih.gov

Extended Anticoagulation after Radical Cystectomy Using Direct Acting Oral Anticoagulants: A Single-Institutional Experience. [2023] Extended prophylactic anticoagulation therapy with enoxaparin 40 mg daily is effective in reducing the incidence of venous thromboembolism (VTE) after radical cystectomy. In an effort to improve compliance, we modified our extended anticoagulation options to direct oral anticoagulants (DOAs; eg apixaban 2.5 mg twice daily or rivaroxaban 10 mg daily). This study assesses our experience with extended VTE prophylaxis using DOAs.

4. France pubmed.ncbi.nlm.nih.gov

[Critical haematuria after prostate biopsies with RIVAROXABAN. Case report]. [2015] Managing patients with new oral anticoagulants in perioperative period is not yet well protocolized. We report a clinical case of a critical haematuria after prostate biopsies to a patient treated with RIVAROXABAN. Monitoring and treatment of the haematuria have been difficult due to the lack of biological control and antidote for this treatment.

5. United States pubmed.ncbi.nlm.nih.gov

Targeting Angiogenesis in Bladder Cancer. [2019] Findings from the phase III RANGE study indicate that adding ramucirumab to docetaxel may improve progression-free survival for patients with advanced or metastatic urothelial carcinoma whose disease is refractory to platinum chemotherapy.