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

NCT04248621 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2021-07-29

No results posted yet for this study

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.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Leuprorelin

LHRH agonist

DRUG

Goserelin

LHRH agonist

DRUG

Triptorelin

LHRH agonist

DRUG

Degarelix

LHRH antagonist

DRUG

Bicalutamide

Antiandrogen

DRUG

Flutamide

Antiandrogen

DRUG

Maximum androgen blockade

Combination therapy with LHRH agonist and antiandrogen

Sponsors & Collaborators

  • Eulji University Hospital

    collaborator OTHER

  • Wonju Severance Christian Hospital

    lead OTHER

Principal Investigators

  • Jinsung Park, MD. PhD. · Department of Urology, Eulji University, College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04248621 on ClinicalTrials.gov