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

Last updated: July 28, 2021
Sponsor: Wonju Severance Christian Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Urologic Cancer

Treatment

N/A

Clinical Study ID

NCT04248621
EMC 2019-12-003-001
  • Ages > 50
  • Male

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.

Eligibility Criteria

Inclusion

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

Exclusion

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 performancestatus 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,

Study Design

Total Participants: 164
Study Start date:
January 23, 2020
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Department of Urology, Chungbuk National University, College of Medicine

    Cheongju,
    Korea, Republic of

    Active - Recruiting

  • Department of Urology, Kyungpook National University, School of Medicine

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Department of Urology, Yeungnam University, College of Medicine

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Department of Urology, Eulji University, College of Medicine

    Daejeon,
    Korea, Republic of

    Active - Recruiting

  • Department of Urology, Konyang University, College of Medicine,

    Daejeon,
    Korea, Republic of

    Active - Recruiting

  • Department of Urology, Chonnam National University, School of Medicine

    Gwangju,
    Korea, Republic of

    Active - Recruiting

  • Department of Urology, Wonkwang University, School of Medicine

    Iksan,
    Korea, Republic of

    Active - Recruiting

  • Department of Urology,Jeonbuk National University Medical School

    Jeonju,
    Korea, Republic of

    Active - Recruiting

  • Department of Urology, Pusan National University, School of Medicine

    Pusan,
    Korea, Republic of

    Active - Recruiting

  • Department of Urology, Yonsei University Wonju College of Medicine

    Wonju,
    Korea, Republic of

    Active - Recruiting

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