Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients
NCT ID: NCT04248621
Last Updated: 2021-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
164 participants
INTERVENTIONAL
2020-01-23
2022-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intermittent Androgen Deprivation
ADT including luteinizing hormone-releasing hormone (LHRH) agonist and antagonist, antiandrogen, or maximum androgen blockade (MAB) should be withdrawn after 6 months of ADT, if the prostate-specific antigen (PSA) reaches its nadir (\< 4 ng/dL) and serum testosterone reaches castration level (\< 50 ng/dL).
Leuprorelin
LHRH agonist
Goserelin
LHRH agonist
Triptorelin
LHRH agonist
Degarelix
LHRH antagonist
Bicalutamide
Antiandrogen
Flutamide
Antiandrogen
Maximum androgen blockade
Combination therapy with LHRH agonist and antiandrogen
Continuous Androgen Deprivation
ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.
Leuprorelin
LHRH agonist
Goserelin
LHRH agonist
Triptorelin
LHRH agonist
Degarelix
LHRH antagonist
Bicalutamide
Antiandrogen
Flutamide
Antiandrogen
Maximum androgen blockade
Combination therapy with LHRH agonist and antiandrogen
Interventions
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Leuprorelin
LHRH agonist
Goserelin
LHRH agonist
Triptorelin
LHRH agonist
Degarelix
LHRH antagonist
Bicalutamide
Antiandrogen
Flutamide
Antiandrogen
Maximum androgen blockade
Combination therapy with LHRH agonist and antiandrogen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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,
50 Years
MALE
No
Sponsors
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Eulji University Hospital
OTHER
Wonju Severance Christian Hospital
OTHER
Responsible Party
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Principal Investigators
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Jinsung Park, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, Eulji University, College of Medicine
Locations
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Department of Urology, Chungbuk National University, College of Medicine
Cheongju-si, , South Korea
Department of Urology, Kyungpook National University, School of Medicine
Daegu, , South Korea
Department of Urology, Yeungnam University, College of Medicine
Daegu, , South Korea
Department of Urology, Eulji University, College of Medicine
Daejeon, , South Korea
Department of Urology, Konyang University, College of Medicine,
Daejeon, , South Korea
Department of Urology, Chonnam National University, School of Medicine
Gwangju, , South Korea
Department of Urology, Wonkwang University, School of Medicine
Iksan, , South Korea
Department of Urology,Jeonbuk National University Medical School
Jeonju, , South Korea
Department of Urology, Pusan National University, School of Medicine
Pusan, , South Korea
Department of Urology, Yonsei University Wonju College of Medicine
Wŏnju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Seok Joong Yun, MD. PhD.
Role: primary
Tae-Hwan Kim, MD. PhD.
Role: primary
Phil Hyun Song, MD. PhD.
Role: primary
Jinsung Park, MD. PhD.
Role: primary
Dae Seon Yoo, MD. PhD.
Role: backup
Hyung Joon Kim, MD.
Role: primary
Eu Chang Hwang, MD. PhD.
Role: primary
Seung Chol Park, MD. PhD.
Role: primary
Young Beom Jeong, MD. PhD.
Role: primary
Sung Woo Park, MD. PhD.
Role: primary
Jae Hung Jung, MD. PhD.
Role: primary
Other Identifiers
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EMC 2019-12-003-001
Identifier Type: -
Identifier Source: org_study_id
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