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Prostatic NeoplasmsPhase 4NCT04248621

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

A Phase 4 study testing Leuprorelin, Goserelin and Triptorelin in people with Prostatic Neoplasms, run by Wonju Severance Christian Hospital at 10 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Leuprorelin, Goserelin and Triptorelin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
10 sitesSouth Korea
Study dates
23 Jan 2020to 31 Dec 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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. .

Who cannot join

  • 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,

Trial locations and contacts

10 sites in 1 country.

Jinsung Park, MD. PhD. contact

+82426113533

jspark.uro@gmail.com

10 sites in 1 country

South Korea10 sites, 10 recruiting

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

    Cheongju-si

    Seok Joong Yun, MD. PhD.

    Recruiting

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

    Daegu

    Tae-Hwan Kim, MD. PhD.

    Recruiting

  • Department of Urology, Yeungnam University, College of Medicine

    Daegu

    Phil Hyun Song, MD. PhD.

    Recruiting

  • Department of Urology, Eulji University, College of Medicine

    Daejeon

    Jinsung Park, MD. PhD.

    Dae Seon Yoo, MD. PhD.

    Recruiting

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

    Daejeon

    Hyung Joon Kim, MD.

    Recruiting

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

    Gwangju

    Eu Chang Hwang, MD. PhD.

    Recruiting

  • Department of Urology, Wonkwang University, School of Medicine

    Iksan

    Seung Chol Park, MD. PhD.

    Recruiting

  • Department of Urology,Jeonbuk National University Medical School

    Jeonju

    Young Beom Jeong, MD. PhD.

    Recruiting

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

    Pusan

    Sung Woo Park, MD. PhD.

    Recruiting

  • Department of Urology, Yonsei University Wonju College of Medicine

    Wŏnju

    Jae Hung Jung, MD. PhD.

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Leuprorelin, Goserelin, Triptorelin, Degarelix, Bicalutamide
Keywords
Androgen Antagonists, Bone Density, Prostatic Neoplasms
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LeuprorelinDrug

    Also called Leuprorelin acetate

    LHRH agonist

  • GoserelinDrug

    Also called Goserelin acetate

    LHRH agonist

  • TriptorelinDrug

    Also called Triptorelin acetate

    LHRH agonist

  • DegarelixDrug

    Also called Degarelix acetate

    LHRH antagonist

  • BicalutamideDrug

    Also called Casodex

    Antiandrogen

  • FlutamideDrug

    Also called Niftolide

    Antiandrogen

  • Maximum androgen blockadeDrug

    Also called LHRN agonist and antiandrogen

    Combination therapy with LHRH agonist and antiandrogen

Study groups in NCT04248621
Study groupRoleWhat they receive
Intermittent Androgen DeprivationExperimentalADT 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).
Receives: Drug: Leuprorelin; Drug: Goserelin; Drug: Triptorelin; Drug: Degarelix; Drug: Bicalutamide; Drug: Flutamide; Drug: Maximum androgen blockade
Continuous Androgen DeprivationActive comparatorADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.
Receives: Drug: Leuprorelin; Drug: Goserelin; Drug: Triptorelin; Drug: Degarelix; Drug: Bicalutamide; Drug: Flutamide; Drug: Maximum androgen blockade

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of L-spine total BMD

    Measured by bone densitometry

    Measured: At baseline and 12 months

Secondary outcomes (4)

  1. Change of femur neck BMD

    Measured by bone densitometry

    Measured: At baseline and 12 months

  2. Osteoporosis

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

    Measured: At 12 months

  3. Risk of 10 year major osteoporotic fracture

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

    Measured: At 12 months

  4. Quality of life after treatment

    Measured by EPIC questionnaire

    Measured: At baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study start23 Jan 2020
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248621
Sponsor's protocol ID
EMC 2019-12-003-001
Status last verified
Jul 2021
First submitted
15 Jan 2020
Last updated
29 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Leuprorelin, Goserelin and Triptorelin in people with Prostatic Neoplasms, run by Wonju Severance Christian Hospital at 10 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jinsung Park, MD. PhD. (+82426113533, jspark.uro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of L-spine total BMD (time frame: At baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.

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