drugset / Trial / NCT04248621

Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients

NCT04248621

RandomizedParallel-groupOpen-labelSupportive care

Summary

Androgen deprivation therapy (ADT) is a mainstay of prostate cancer treatment to improve overall survival for intermediate- and high-risk localized disease as well as metastatic disease. While ADT improves survival, it can cause significant morbidity and a decrement in quality of life. In particular, ADT is associated with decrease in bone mineral density (BMD) and increased risk of fracture. Although current guidelines recommend continuous androgen deprivation therapy (CAD) as standard therapy for high-risk disease, there has been increasing recognition of adverse effects from CAD. Since 1986, intermittent androgen deprivation therapy (IAD) as alternative therapeutic strategy for prostate cancer has been proposed to delay development of castration resistance and to reduce the side effects of ADT. While both CAD and IAD are commonly used in real clinical practice, no prior study examined BMD change after CAD or IAD, and assessed whether bone loss would recover during off-treatment of IAD. The investigators therefore determine the rate of change in BMD induced by ADT (CAD versus IAD) in men with prostate cancer.

Timeline

Start
2020-01-23
Primary completion
2022-04-30
Completion
2022-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bicalutamide Other / unclassified
Subject Degarelix Other / unclassified
Subject Goserelin Other / unclassified
Subject Leuprolide Other / unclassified
Subject Triptorelin Other / unclassified
Subject flutamide Small molecule

Indications