This randomized phase II/III trial studies how well heparin works in preventing blood clots in patients with prostate cancer after surgery. Heparin may be a better way to prevent blood clots (in the legs or in the lungs) for men undergoing radical prostatectomy for prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03006562.
PRIMARY OBJECTIVES:
I. Whether the use of perioperative pharmacologic agents (subcutaneous heparin; 5,000 units given before surgery and every 8 hours after surgery until discharge), compared to pneumatic compression devices (IPCs) alone, for radical prostatectomy (RP) for prostate cancer prevent the occurrence of symptomatic venous thromboembolism (VTE) following surgery.
II. Whether the use of perioperative pharmacologic agents (subcutaneous heparin; 5,000 units given before surgery and every 8 hours after surgery until discharge), compared to IPCs alone, for RP for prostate cancer increase the incidence of clinically significant lymphocele.
III. Whether the use of perioperative pharmacologic agents (subcutaneous heparin; 5,000 units given before surgery and every 8 hours after surgery until discharge), compared to IPCs alone, for RP for prostate cancer increase the incidence of clinically significant hematoma.
IV. Whether the use of perioperative pharmacologic agents (subcutaneous heparin; 5,000 units given before surgery and every 8 hours after surgery until discharge), compared to IPCs alone, for RP for prostate cancer increase the incidence of major bleeding following surgery.
SECONDARY OBJECTIVES:
I. Whether the use of perioperative pharmacologic agents (subcutaneous heparin; 5,000 units given before surgery and every 8 hours after surgery until discharge), compared to IPCs alone, for RP for prostate cancer prevent the occurrence of any VTE (asymptomatic or symptomatic) following surgery.
II. Whether the use of perioperative pharmacologic agents (subcutaneous heparin; 5,000 units given before surgery and every 8 hours after surgery until discharge), compared to IPCs alone, for RP for prostate cancer increase estimated blood loss during surgery.
III. Whether the use of perioperative pharmacologic agents (subcutaneous heparin; 5,000 units given before surgery and every 8 hours after surgery until discharge), compared to IPCs alone, for RP for prostate cancer increase surgical drain output after surgery.
IV. Whether the use of perioperative pharmacologic agents (subcutaneous heparin; 5,000 units given before surgery and every 8 hours after surgery until discharge), compared to IPCs alone, for RP for prostate cancer lead to potential surveillance bias measured by increased or decreased use of diagnostic imaging for VTE relative to symptoms (e.g. lower extremity Duplex ultrasound, spiral computed tomography [CT] angiography, V/Q scan, etc.).
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients receive heparin subcutaneously (SC) with IPCs within 2 hours before surgery and every 8 hours after surgery until discharge in the absence of disease progression or unaccepted toxicity.
ARM II: Patients receive standard of care with pneumatic compression devices alone.
After completion of study treatment, patients are followed up at 30 days post surgery.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorMohamad E. Allaf
