Overview

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

Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wonju Severance Christian Hospital
Collaborator:
Eulji University Hospital
Treatments:
Androgen Antagonists
Androgens
Bicalutamide
Flutamide
Goserelin
Leuprolide
Triptorelin Pamoate
Criteria
Inclusion Criteria:

Men aged over 50 yrs old with histologically diagnosed prostate cancer (localized, locally
advanced, metastatic prostate cancer) who are treated with primary ADT for newly diagnosed
prostate cancer or salvage ADT at biochemical recurrence following radical prostatectomy. .

Exclusion Criteria:

1. men with double primary malignancies,

2. men who have been treated with ADT or other drug therapy such as denosumab,
bisphosphonate or steroid,

3. men with osteoporosis at baseline (T-score ≤ -2.5),

4. men with a known bone disease,

5. men with poor performance status (i.e. Eastern Cooperative Oncology Group performance
status 4),

6. men with life expectancy < 12 months,

7. men with increased serum PSA levels (≥ 4 ng/dL) or testosterone levels (≥ 50 ng/dL)
even after 6 month ADT,

8. men who are not able to understand trial information or informed consent,