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.
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.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- 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.
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.
- Conditions
- Prostatic Neoplasms
- 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 group | Role | What they receive |
|---|---|---|
| Intermittent Androgen Deprivation | Experimental | 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). Receives: Drug: Leuprorelin; Drug: Goserelin; Drug: Triptorelin; Drug: Degarelix; Drug: Bicalutamide; Drug: Flutamide; Drug: Maximum androgen blockade |
| Continuous Androgen Deprivation | Active comparator | ADT 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.
Change of L-spine total BMD
Measured by bone densitometry
Measured: At baseline and 12 months
Secondary outcomes (4)
Change of femur neck BMD
Measured by bone densitometry
Measured: At baseline and 12 months
Osteoporosis
Defined as newly diagnosed osteoporosis based on T-score (≤ -2.5)
Measured: At 12 months
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
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.
- First posted30 Jan 2020
- Study start23 Jan 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eulji University Hospital
- Responsible party
- Sponsor
- Investigators
- Jinsung Park, MD. PhD., Principal investigator, Department of Urology, Eulji University, College of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04248621
- Acronym / sponsor ID
- EMC 2019-12-003-001
- Conditions
- Prostatic Neoplasms
- Keywords
- Androgen Antagonists, Bone Density, Prostatic Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Collaborators
- Eulji University Hospital
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Androgen Deprivation | Experimental | Drug: Leuprorelin, Drug: Goserelin, Drug: Triptorelin, Drug: Degarelix, Drug: Bicalutamide, Drug: Flutamide, Drug: Maximum androgen blockadeADT 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). |
| Continuous Androgen Deprivation | Active comparator | Drug: Leuprorelin, Drug: Goserelin, Drug: Triptorelin, Drug: Degarelix, Drug: Bicalutamide, Drug: Flutamide, Drug: Maximum androgen blockadeADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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. .
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeuprorelinAlso: Leuprorelin acetateLHRH agonist | Drug | Continuous Androgen Deprivation, Intermittent Androgen Deprivation |
| GoserelinAlso: Goserelin acetateLHRH agonist | Drug | Continuous Androgen Deprivation, Intermittent Androgen Deprivation |
| TriptorelinAlso: Triptorelin acetateLHRH agonist | Drug | Continuous Androgen Deprivation, Intermittent Androgen Deprivation |
| DegarelixAlso: Degarelix acetateLHRH antagonist | Drug | Continuous Androgen Deprivation, Intermittent Androgen Deprivation |
| BicalutamideAlso: CasodexAntiandrogen | Drug | Continuous Androgen Deprivation, Intermittent Androgen Deprivation |
| FlutamideAlso: NiftolideAntiandrogen | Drug | Continuous Androgen Deprivation, Intermittent Androgen Deprivation |
| Maximum androgen blockadeAlso: LHRN agonist and antiandrogenCombination therapy with LHRH agonist and antiandrogen | Drug | Continuous Androgen Deprivation, Intermittent Androgen Deprivation |
Primary outcome
Change of L-spine total BMD
Time frame: At baseline and 12 months
Measured by bone densitometry
4 secondary outcomes
Change of femur neck BMD
Time frame: At baseline and 12 months
Osteoporosis
Time frame: At 12 months
Risk of 10 year major osteoporotic fracture
Time frame: At 12 months
Quality of life after treatment
Time frame: At baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinsung Park, MD. PhD. principal investigator
Department of Urology, Eulji University, College of Medicine
10 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 7 Nov 2026.