A clinical study for the long-term protection of prostate and breast cancer patients from thrombosis

Long-term thromboprophylaxis with tinzaparin in high-risk prostate or breast cancer patients. A prospective, randomised, international multicentre, open-label, blinded-endpoint Phase III study. PROBE design PRONIA-CAT study - PRONIA-CAT study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001230-18-GR

Enrollment

1052

Registered

2018-12-05

Start date

2019-01-30

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term thromboprophylaxis with tinzaparin in high-risk prostate or breast cancer patients. MedDRA version: 20.0 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865

Interventions

Trade Name: INNOHEP® Product Name: Tinzaparin (Innohep) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: TINZAPARIN SODIUM CAS Number: 9041-08-1 Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Histologically confirmed breast or prostate cancer, including previously untreated patients and patients with recurrent disease after previous local and/or systemic therapy •Age =18 years •Planned endocrine therapy, chemotherapy, or targeted anticancer therapy within 1 month from study enrolment; patients may also have started such therapy less than 1 month before study enrolment •High risk for VTE according to the COMPASS-CAT RAM (score =7) •ECOG 0-2 •Life expectancy >6 months •Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 632 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 420

Exclusion criteria

Exclusion criteria: •Hypersensitivity to heparin •History of heparin-induced thrombocytopenia •Ongoing anticoagulant treatment (patients receiving antiplatelet agents are not excluded) •Objectively confirmed VTE at inclusion before treatment group assignment or incidental VTE found when imaging methods for disease staging are performed •Creatinine clearance 5 × ULN, bilirubin >2 × ULN •Cancer treated exclusively with supportive care •Patient enrolled in another trial at the time of screening •Recent (<1 month) oncological surgery, major abdominal or thoracic surgery, major orthopaedic surgery, vascular surgery •Recent (<1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or haemorrhagic stroke •Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the PRONIA-CAT trial is to investigate the efficacy and safety of long-term VTE prevention with administration of tinzaparin (4500 anti-Xa IU s.c. o.d. for 6 months) in patients scheduled to start anticancer treatment or receiving standard care anticancer for a maximum period of 1 month, for breast or prostate cancer and who are identified at high thromboembolic risk according to the COMPASS-CAT RAM stratification. ;Secondary Objective: Not applicable;Primary end point(s): The composite of all objectively confirmed VTE events during the 6-month treatment period including: symptomatic or incidental distal DVT; symptomatic or incidental proximal DVT (including iliac and cava thrombosis); symptomatic or incidental PE, or both (DVT and PE); symptomatic or incidental CVC thrombosis or upper limb vein thrombosis (not related to the CVC); vein thrombosis of rare localisation (i.e., splanchnic vein or cerebral vein thrombosis); or death due to PE. ;Timepoint(s) of evaluation of this end point: Primary efficacy and safety endpoints will be assessed at 180 days after randomisation. Total observation period will be 360 days.	—

Measure

Time frame

Main Objective: The objective of the PRONIA-CAT trial is to investigate the efficacy and safety of long-term VTE prevention with administration of tinzaparin (4500 anti-Xa IU s.c. o.d. for 6 months) in patients scheduled to start anticancer treatment or receiving standard care anticancer for a maximum period of 1 month, for breast or prostate cancer and who are identified at high thromboembolic risk according to the COMPASS-CAT RAM stratification. ;Secondary Objective: Not applicable;Primary end point(s): The composite of all objectively confirmed VTE events during the 6-month treatment period including: symptomatic or incidental distal DVT; symptomatic or incidental proximal DVT (including iliac and cava thrombosis); symptomatic or incidental PE, or both (DVT and PE); symptomatic or incidental CVC thrombosis or upper limb vein thrombosis (not related to the CVC); vein thrombosis of rare localisation (i.e., splanchnic vein or cerebral vein thrombosis); or death due to PE. ;Timepoint(s) of evaluation of this end point: Primary efficacy and safety endpoints will be assessed at 180 days after randomisation. Total observation period will be 360 days.

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Secondary

Measure	Time frame
Secondary end point(s): •Objectively confirmed symptomatic VTE and death due to PE during the 6-month treatment period •Objectively confirmed symptomatic or incidental VTE during the 12-month study period •Objectively confirmed symptomatic or incidental VTE during the 6-month treatment period in the predefined subgroup of patients with breast cancer •Objectively confirmed symptomatic or incidental VTE during the 6-month treatment period in the predefined subgroup of patients with prostate cancer •Overall mortality and causes of death during the 6-month treatment period and during the overall 12-month study period •Progression-free survival in patients in each studied group •Progression-free survival in patients with antiangiogenic treatments •Evaluation of the burden of VTE (using data of the control group) and estimation of the cost of VTE treatment as well as of the socioeconomic benefit from the application of thromboprophylaxis with tinzaparin ;Timepoint(s) of evaluation of this end point: During each visit, the search for VTE events, bleeding, and other study endpoints will be done systematically using a structured questionnaire. All CT reports will be checked for VTE and bleeding events. All suspected outcomes will be centrally adjudicated by a clinical events committee unaware of treatment allocation.	—

Measure

Time frame

Secondary end point(s): •Objectively confirmed symptomatic VTE and death due to PE during the 6-month treatment period •Objectively confirmed symptomatic or incidental VTE during the 12-month study period •Objectively confirmed symptomatic or incidental VTE during the 6-month treatment period in the predefined subgroup of patients with breast cancer •Objectively confirmed symptomatic or incidental VTE during the 6-month treatment period in the predefined subgroup of patients with prostate cancer •Overall mortality and causes of death during the 6-month treatment period and during the overall 12-month study period •Progression-free survival in patients in each studied group •Progression-free survival in patients with antiangiogenic treatments •Evaluation of the burden of VTE (using data of the control group) and estimation of the cost of VTE treatment as well as of the socioeconomic benefit from the application of thromboprophylaxis with tinzaparin ;Timepoint(s) of evaluation of this end point: During each visit, the search for VTE events, bleeding, and other study endpoints will be done systematically using a structured questionnaire. All CT reports will be checked for VTE and bleeding events. All suspected outcomes will be centrally adjudicated by a clinical events committee unaware of treatment allocation.

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Countries

France, Greece, Spain

Contacts

Public ContactGrigoris Gerotziafas

Hôpitaux Universitaires de l'Est Parisien Tenon – APHP

gregtnn@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026