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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    164
  • sponsor
    Wonju Severance Christian Hospital
Updated on 6 August 2021
prostatectomy
cancer
androgens
metastasis
antiandrogen therapy
androgen suppression
bicalutamide
flutamide
metastatic prostate cancer
leuprolide
goserelin
degarelix
cancer treatment
triptorelin
prostate cancer metastatic

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.

Description

Objective: To determine the rate of bone mass loss induced by two therapeutic strategies of ADT (CAD versus IAD) in men with prostate cancer.

Design, setting, and participants: the investigators will perform randomized, open label clinical trial. Men aged over 50 yrs old with 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 will be included.

Participants will be randomly assigned to one of the following treatment arms:

Arm 1 (CAD): ADT without any discontinuation during study period (12 months).

Arm 2 (IAD): ADT for the first 6 months of study period, if the prostate-specific antigen (PSA) reaches its nadir (< 4 ng/dL) and serum testosterone reaches castration level (< 50 ng/dL).

Outcomes

Primary outcome: change of L-spine total BMD. Secondary outcomes: change of femur neck BMD, incidence rate of osteoporosis, risk of 10 year major osteoporotic fracture, quality of life based on Expanded Prostate Cancer Index (EPIC) questionnaire.

Timing of outcome measurement: at baseline and up to 12 months after randomization.

Statistical analyses: student's t test for continuous outcomes and Fisher's exact or chi-square test for dichotomous outcomes.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate tumor, prostate tumors
Treatment bicalutamide, Triptorelin, flutamide, Goserelin, Degarelix, Leuprorelin, MAB, Maximum androgen blockade
Clinical Study IdentifierNCT04248621
SponsorWonju Severance Christian Hospital
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

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

men with double primary malignancies
men who have been treated with ADT or other drug therapy such as denosumab, bisphosphonate or steroid
men with osteoporosis at baseline (T-score -2.5)
men with a known bone disease
men with poor performance status (i.e. Eastern Cooperative Oncology Group performance status 4)
men with life expectancy < 12 months
men with increased serum PSA levels ( 4 ng/dL) or testosterone levels ( 50 ng/dL) even after 6 month ADT
men who are not able to understand trial information or informed consent
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