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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT04248621 (opens ClinicalTrials.gov in a new tab)Other idEMC 2019-12-003-001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
164 participants (estimated)
Sponsor
Wonju Severance Christian Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

South Korea

Start
23 Jan 2020
Primary completion
30 Apr 2022 (estimated)
Completion
31 Dec 2022 (estimated)
First posted
30 Jan 2020
Last update posted
29 Jul 2021
Conditions
Prostatic Neoplasms

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023
  1. Ph 4

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

    NCT04248621

    23 Jan 2020 to est. 31 Dec 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LeuprorelinDrug
  • GoserelinDrug
  • TriptorelinDrug
  • DegarelixDrug
  • BicalutamideDrug
  • FlutamideDrug
  • Maximum androgen blockadeDrug

Arms2

  • 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).

  • Active comparator

    Continuous Androgen Deprivation

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change of L-spine total BMD

    Time frame · At baseline and 12 months

    Registry description

    Measured by bone densitometry

Secondary outcomes(4)

  1. Change of femur neck BMD

    Time frame · At baseline and 12 months

    Registry description

    Measured by bone densitometry

  2. Osteoporosis

    Time frame · At 12 months

    Registry description

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

  3. Risk of 10 year major osteoporotic fracture

    Time frame · At 12 months

    Registry description

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

  4. Quality of life after treatment

    Time frame · At baseline and 12 months

    Registry description

    Measured by EPIC questionnaire

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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,

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