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

Sponsor
Wonju Severance Christian Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04248621
Collaborator
Eulji University Hospital (Other)
164
Enrollment
10
Locations
2
Arms
35.3
Anticipated Duration (Months)
16.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Impact of Continuous Versus Intermittent Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients: A Multicenter, Randomized Clinical Trial
Actual Study Start Date :
Jan 23, 2020
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Drug: Leuprorelin
LHRH agonist
Other Names:
  • Leuprorelin acetate

    • Drug: Goserelin
    LHRH agonist
    Other Names:
  • Goserelin acetate

    • Drug: Triptorelin
    LHRH agonist
    Other Names:
  • Triptorelin acetate

    • Drug: Degarelix
    LHRH antagonist
    Other Names:
  • Degarelix acetate

    • Drug: Bicalutamide
    Antiandrogen
    Other Names:
  • Casodex

    • Drug: Flutamide
    Antiandrogen
    Other Names:
  • Niftolide

    • Drug: Maximum androgen blockade
    Combination therapy with LHRH agonist and antiandrogen
    Other Names:
  • LHRN agonist and antiandrogen

    		•
    Active Comparator: Continuous Androgen Deprivation

    ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.

    Drug: Leuprorelin
    LHRH agonist
    Other Names:
  • Leuprorelin acetate

    • Drug: Goserelin
    LHRH agonist
    Other Names:
  • Goserelin acetate

    • Drug: Triptorelin
    LHRH agonist
    Other Names:
  • Triptorelin acetate

    • Drug: Degarelix
    LHRH antagonist
    Other Names:
  • Degarelix acetate

    • Drug: Bicalutamide
    Antiandrogen
    Other Names:
  • Casodex

    • Drug: Flutamide
    Antiandrogen
    Other Names:
  • Niftolide

    • Drug: Maximum androgen blockade
    Combination therapy with LHRH agonist and antiandrogen
    Other Names:
  • LHRN agonist and antiandrogen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of L-spine total BMD [At baseline and 12 months]

      Measured by bone densitometry

    Secondary Outcome Measures

    1. Change of femur neck BMD [At baseline and 12 months]

      Measured by bone densitometry

    2. Osteoporosis [At 12 months]

      Defined as newly diagnosed osteoporosis based on T-score (≤ -2.5)

    3. Risk of 10 year major osteoporotic fracture [At 12 months]

      Estimated by Fracture Risk Assessment Tool (FRAX®, available at www.sheffield.ac.uk/FRAX)

    4. Quality of life after treatment [At baseline and 12 months]

      Measured by EPIC questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Urology, Chungbuk National University, College of Medicine Cheongju Korea, Republic of
    2 Department of Urology, Kyungpook National University, School of Medicine Daegu Korea, Republic of
    3 Department of Urology, Yeungnam University, College of Medicine Daegu Korea, Republic of
    4 Department of Urology, Eulji University, College of Medicine Daejeon Korea, Republic of
    5 Department of Urology, Konyang University, College of Medicine, Daejeon Korea, Republic of
    6 Department of Urology, Chonnam National University, School of Medicine Gwangju Korea, Republic of
    7 Department of Urology, Wonkwang University, School of Medicine Iksan Korea, Republic of
    8 Department of Urology,Jeonbuk National University Medical School Jeonju Korea, Republic of
    9 Department of Urology, Pusan National University, School of Medicine Pusan Korea, Republic of
    10 Department of Urology, Yonsei University Wonju College of Medicine Wonju Korea, Republic of

    Sponsors and Collaborators

    • Wonju Severance Christian Hospital
    • Eulji University Hospital

    Investigators

    • Principal Investigator: Jinsung Park, MD. PhD., Department of Urology, Eulji University, College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wonju Severance Christian Hospital
    ClinicalTrials.gov Identifier:
    NCT04248621
    Other Study ID Numbers:
    • EMC 2019-12-003-001
    First Posted:
    Jan 30, 2020
    Last Update Posted:
    Jul 29, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wonju Severance Christian Hospital
    Androgen Antagonists
    Bone Density
    Prostatic Neoplasms
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Goserelin
    Triptorelin Pamoate
    Leuprolide
    Flutamide
    Bicalutamide
    Androgen Antagonists
    Androgens

    Study Results

    No Results Posted as of Jul 29, 2021