Venous ThromboembolismPhase 2/3PREVENT-GUNCT05920343
VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy
A Phase 2/3 study testing Rivaroxaban 10 MG in people with Venous Thromboembolism and Urologic Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Urologic Cancer
- What is being tested?
- Rivaroxaban 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 4 Nov 2024to Oct 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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))
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- 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.
- Patients may be excluded from the study for other reasons, at the investigator's discretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Luke Lavallee, MDCM MSc FRCSC, 613-737-8899 ext. 73019, lulavallee@toh.ca
David Yachnin, MSc, 613-737-5555 ext. 74639, dyachnin@toh.ca
About this study
Official title: Prevention of Thromboembolism With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy: A Randomized Placebo-Controlled, Double-Blind Clinical 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.
Read the detailed description
Background and Importance: Patients with cancer receiving systemic therapy are at high risk of venous thromboembolism (VTE). Thromboprophylaxis with antiocoagulants reduces VTEs during chemotherapy by 60%. Despite this, thromboprophylaxis is not routinely used in Canada for patients with genitourinary (GU) malignancies (bladder, testis, kidney). Reasons prophylaxis is not used are that very few GU patients were included in landmark trials evaluating DOACs, and because GU patients may be at higher risk of bleeding compared to non-GU cancer patients. The omission of GU patients from prior trials has created an important gap in knowledge because these patients have among the highest risk of VTE of all cancer patients. Prior studies have reported VTE rates during chemotherapy for bladder and testis cancer in the range of 10-15%, well above thresholds at which guidelines usually recommend thromboprophylaxis.
Hypotheses: The investigators hypothesize that thromboprophylaxis with a direct oral anticoagulant (DOAC) during systemic therapy for GU malignancies will reduce the risk of VTE with acceptable risk of major bleeding. Secondly, the investigators hypothesize that a randomized trial of thromboprophylaxis versus placebo in GU patients is feasible and needed to change care in Canada.
Research goals: The goal of this pilot study is to determine if a randomized control trial of thromboprophylaxis with rivaroxaban versus placebo in GU patients receiving systemic therapy is feasible.
Methods: This internal pilot feasibility study will randomize patients with GU malignancies receiving systemic therapy (patients) to rivaroxaban 10mg daily (intervention) versus placebo (control). The primary outcome of this internal pilot study will be feasibility of patient accrual. Feasibility will be reported as the average number of patients enrolled per month. Secondary outcomes will be time to trial initiation, number of patients enrolled per site, and proportion of patients who complete the intervention. If feasibility is confirmed, patients enrolled in the pilot will be included in the full trial using a vanguard design.
The primary outcome(s) of the full trial will be VTE (efficacy outcome) and major bleeding (safety outcome) during the intervention. Patient reported outcomes including quality of life will also be recorded.
Expected outcomes: While thromboprophylaxis is effective in cancer patients, medical guidelines only recommend prophylaxis for some patients due to limited evidence in disease-specific subgroups. Importantly, safety concerns in GU patients are a particular concern necessitating further study of this population. The investigators expect the results of this internal pilot study to prove feasibility of a full trial. The full trial will determine the net benefits/harms of prophylaxis in GU patients and change practice worldwide, regardless of the results.
- Conditions
- Venous Thromboembolism, Urologic Cancer
- Being tested
- Rivaroxaban 10 MG, Placebo control
- Keywords
- Genitourinary Cancer, Venous Thromboembolism, Systemic Therapy, Thromboprophylaxis
- Medical subject headings
- Venous Thromboembolism, Urologic Neoplasms, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10 MGDrug
Also called Xarelto
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).
Placebo controlOther
Identical to Rivaroxaban intervention except participants will receive a matched placebo instead of the study drug
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Participants receiving study drug (Rivaroxaban) Receives: Drug: Rivaroxaban 10 MG |
| Control | Placebo comparator | Participants receiving matched placebo Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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,
This outcome will measure patient adherence to the study intervention (defined as >80% of medication taken during the study intervention period). This will be assessed using pill counts during study follow-ups.
Measured: During 180 days of study intervention
Recruitment rate
Number of participants recruited per month at each study site
Measured: Enrollment
VTE incidence
VTE will be recorded and adjudicated similarly to the full trial. Outcomes will be examined in aggregate to ascertain an estimate of baseline risk for patients in the trial. VTE outcomes will NOT be examined or reported by allocation group in the Pilot so all patients can be included in Full Trial analyses (internal pilot design).
Measured: During 180 days of study intervention
Bleeding incidence
Bleeding outcomes (major and minor) will be recorded and adjudicated similarly to the full trial. Outcomes will be examined in aggregate to ascertain an estimate of baseline risk for patients in the trial. Bleeding outcomes will NOT be examined or reported by allocation group in the Pilot so all patients can be included in Full Trial analyses (internal pilot design).
Measured: During 180 days of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start4 Nov 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, Kidney Cancer Research Network of Canada
- Responsible party
- Sponsor
- Investigators
- Luke T Lavallee, MDCM MSc FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920343
- Sponsor's protocol ID
- PGU2023
- Acronym
- PREVENT-GU
- Status last verified
- Jul 2025
- First submitted
- 8 Jun 2023
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Thromboembolism With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy: A Randomized Placebo-Controlled, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05920343
- Acronym / sponsor ID
- PREVENT-GU / PGU2023
- Conditions
- Venous Thromboembolism, Urologic Cancer
- Keywords
- Genitourinary Cancer, Venous Thromboembolism, Systemic Therapy, Thromboprophylaxis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, Kidney Cancer Research Network of Canada
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Importance: Patients with cancer receiving systemic therapy are at high risk of venous thromboembolism (VTE). Thromboprophylaxis with antiocoagulants reduces VTEs during chemotherapy by 60%. Despite this, thromboprophylaxis is not routinely used in Canada for patients with genitourinary (GU) malignancies (bladder, testis, kidney). Reasons prophylaxis is not used are that very few GU patients were included in landmark trials evaluating DOACs, and because GU patients may be at higher risk of bleeding compared to non-GU cancer patients. The omission of GU patients from prior trials has created an important gap in knowledge because these patients have among the highest risk of VTE of all cancer patients. Prior studies have reported VTE rates during chemotherapy for bladder and testis cancer in the range of 10-15%, well above thresholds at which guidelines usually recommend thromboprophylaxis.
Hypotheses: The investigators hypothesize that thromboprophylaxis with a direct oral anticoagulant (DOAC) during systemic therapy for GU malignancies will reduce the risk of VTE with acceptable risk of major bleeding. Secondly, the investigators hypothesize that a randomized trial of thromboprophylaxis versus placebo in GU patients is feasible and needed to change care in Canada.
Research goals: The goal of this pilot study is to determine if a randomized control trial of thromboprophylaxis with rivaroxaban versus placebo in GU patients receiving systemic therapy is feasible.
Methods: This internal pilot feasibility study will randomize patients with GU malignancies receiving systemic therapy (patients) to rivaroxaban 10mg daily (intervention) versus placebo (control). The primary outcome of this internal pilot study will be feasibility of patient accrual. Feasibility will be reported as the average number of patients enrolled per month. Secondary outcomes will be time to trial initiation, number of patients enrolled per site, and proportion of patients who complete the intervention. If feasibility is confirmed, patients enrolled in the pilot will be included in the full trial using a vanguard design.
The primary outcome(s) of the full trial will be VTE (efficacy outcome) and major bleeding (safety outcome) during the intervention. Patient reported outcomes including quality of life will also be recorded.
Expected outcomes: While thromboprophylaxis is effective in cancer patients, medical guidelines only recommend prophylaxis for some patients due to limited evidence in disease-specific subgroups. Importantly, safety concerns in GU patients are a particular concern necessitating further study of this population. The investigators expect the results of this internal pilot study to prove feasibility of a full trial. The full trial will determine the net benefits/harms of prophylaxis in GU patients and change practice worldwide, regardless of the results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: Rivaroxaban 10 MGParticipants receiving study drug (Rivaroxaban) |
| Control | Placebo comparator | Other: Placebo controlParticipants receiving matched placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 10 MGAlso: XareltoThe 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). | Drug | Rivaroxaban |
| Placebo controlIdentical to Rivaroxaban intervention except participants will receive a matched placebo instead of the study drug | Other | Control |
Primary outcome
Feasibility of enrollment, assesed by the number of patients accrued per month
Time frame: Enrollment
The primary outcome of this Pilot Trial is feasibility of enrollment. Feasibility will be measured by the average number of patients accrued per month.
4 secondary outcomes
Adherence to the study intervention, assessed as the proportion of patients taking the study medication >80% of days taken during the study period,
Time frame: During 180 days of study intervention
Recruitment rate
Time frame: Enrollment
VTE incidence
Time frame: During 180 days of study intervention
Bleeding incidence
Time frame: During 180 days of study intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No. No plan to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luke T Lavallee, MDCM MSc FRCSC principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rivaroxaban 10 MG in people with Venous Thromboembolism and Urologic Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luke T Lavallee, MDCM MSc FRCSC (613-737-8899 ext. 71393, lulavallee@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of enrollment, assesed by the number of patients accrued per month (time frame: Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.