Prostate Cancer (Adenocarcinoma)NCT06838520
Effect of ADT and ARPI on Bone Loss of Patients with Prostate Cancer
An observational study of Prostate Cancer (Adenocarcinoma), run by The First Affiliated Hospital with Nanjing Medical University at 4 sites in China.
Trial summary
This study aims to assess the impact of Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPI) on bone quality in patients with prostate cancer. Patients undergoing ADT for prostate cancer often experience adverse effects such as decreased bone density and increased fracture risk. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Bone health assessment
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- 1 Apr 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This study will include male patients with locally advanced or metastatic hormone-sensitive prostate cancer (mHSPC) in mainland China. All patients must have visited the urology or oncology outpatient departments of a tertiary hospital and have a pathological confirmation of the disease.
Who may be able to join
- Age ≥ 18 years, male gender;
- Histologically or cytologically confirmed prostate cancer;
- Clinical stage of metastatic hormone-sensitive prostate cancer (mHSPC);
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
- Life expectancy ≥ 12 months;
- Willing and able to provide written informed consent.
Who cannot join
- Suffering from double primary malignancies.
- Having previously received androgen deprivation therapy (ADT) or other pharmacological treatments (e.g., denosumab, bisphosphonates, or corticosteroids).
- Having osteoporosis at baseline (T-score ≤ -2.5).
- Having known bone diseases.
- Having spinal metastases confirmed by imaging (e.g., ECT, MRI, CT, or PSMA PET-CT).
- Having poor general condition (i.e., ECOG ≥ 4).
- Having a life expectancy of less than 12 months.
- Having elevated serum PSA levels (≥4 ng/dL) or testosterone levels (≥50 ng/dL) after 6 months of ADT.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
The Third Affiliated Hospital of Soochow University
Changzhou, Jiangsu, 213004
Dong Xue, MD, +8615251840611, xuedongdx@163.com
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009
Bianjiang Liu, MD, +8613851493417, bjliu@njmu.edu.cn
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xuedong Wei, MD, +8615251840611, wxd0422@163.com
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225009
Xuefei Ding, +8615251840611, xuefeid@126.com
About this study
Official title: A Prospective Study on the Impact of Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPI) on Bone Loss in Prostate Cancer Patients
This study aims to assess the impact of Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPI) on bone quality in patients with prostate cancer. Patients undergoing ADT for prostate cancer often experience adverse effects such as decreased bone density and increased fracture risk. While ARPIs are emerging as novel therapeutic agents, their effects on bone quality remain unclear. This study will compare patients receiving combined ADT and ARPI therapy with those receiving ADT alone, evaluating changes in bone density, bone microarchitecture, and bone metabolic markers. The findings will help optimize treatment strategies for prostate cancer patients, reduce the risk of osteoporosis, and improve overall quality of life.
Read the detailed description
Prostate cancer is the second most common malignancy in men worldwide and ranks fifth in cancer mortality among men. In developed countries in Europe and America, it has the highest incidence rate. In recent years, with the development of the social economy, increased life expectancy, changes in lifestyle, and improvements in the level of medical and health care, the incidence of prostate cancer in China is gradually rising, posing a serious threat to the life safety of men. In China, more than half of the patients with newly diagnosed prostate cancer have advanced metastatic disease. The skeleton is the most common site of metastasis in these patients. Metastatic lesions may cause pathological fractures and spinal cord compression. Patients with extensive bone metastasis are prone to fatigue, weight loss, anemia, and in severe cases, even systemic organ failure. Hormonal therapy based on ADT remains the main treatment for advanced prostate cancer, with the goal of reducing or eliminating the promoting effect of androgens on cancer cell growth.
While ADT treatment benefits patients with metastatic prostate cancer, it also leads to numerous side effects, such as cardiovascular diseases, changes in body composition, decreased bone mineral density (BMD), hot flashes, gynecomastia, cognitive decline, fatigue, anemia, and sexual dysfunction. ADT treatment can affect the number and function of osteoblasts and osteoclasts through various pathways, disrupting the balance of bone remodeling and leading to cancer treatment-induced bone loss. Under normal conditions, testosterone can be converted to estradiol via aromatase and bind to the estrogen receptors on the surface of osteoclasts, indirectly regulating these cells. With increasing age, the bioactivity of both testosterone and estrogen declines in normal men, resulting in low-turnover bone metabolic changes and a bone loss rate of 0.5% to 1% per year. In patients undergoing ADT, the levels of testosterone and estrogen decrease more significantly, and the number of osteoclasts increases markedly. Moreover, ADT treatment can reduce muscle mass and increase fat, leading to sarcopenic obesity, which is accompanied by chronic low-grade inflammation throughout the body and disrupts bone homeostasis. ADT may also lower the levels of circulating vitamin D, which not only affects bone mineralization but also has adverse effects on skeletal muscle and prostate cancer itself. Studies have shown that after 12 months of ADT treatment, the median lumbar spine BMD in patients decreased by an average of 3.6%, higher than that in untreated elderly men (0.5% to 1%). The BLADE study (NCT03202381) confirmed that long-term ADT treatment with either Gonadotropin-releasing hormone (GnRH) receptor agonists or antagonists significantly reduces bone quality. In fact, bone loss caused by ADT treatment can also lead to skeletal-related events (SREs), represented by pathological fractures, bone radiotherapy, bone surgery, and spinal cord compression.
ARPIs play a crucial role in the treatment of prostate cancer. Prostate cancer cells often rely on androgens for growth, and ARPIs work by blocking the androgen receptor pathway, thereby inhibiting the proliferation of cancer cells. These inhibitors, such as abiraterone, enzalutamide, and apalutamide, have significantly improved outcomes for patients with advanced prostate cancer, including those with metastatic castration-resistant prostate cancer (mCRPC). By reducing the levels of androgens or blocking their effects, ARPIs may also negatively impact bone quality in patients with prostate cancer. These agents, by reducing androgen levels, may lead to decreased BMD and increased fracture risk.
The impact of combining ADT with ARPIs on bone quality remains unclear. While clinical trial data on ARPIs in nonmetastatic castration-resistant prostate cancer (nmCRPC) have shown mixed results regarding bone health. Further research is needed to fully understand the combined effects of ADT and ARPIs on bone quality. It is essential to gain a deeper understanding of the patterns of osteoporosis to provide most effective bone-protective therapies to prevent the occurrence of SREs.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- Bone health assessment
- Keywords
- prostate cancer, ADT, ARPI, bone health
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone health assessmentOther
Assessments of physical function, DXA scan
| Study group | Role | What they receive |
|---|---|---|
| Group A: ADT alone | Men with locally advanced prostate cancer or metastatic hormone-sensitive prostate cancer, about to start treatment.
ADT including LHRH agonist and antagonist. Receives: Other: Bone health assessment | |
| Group B: ADT + ARPIs | Men with locally advanced prostate cancer or metastatic hormone-sensitive prostate cancer, about to start treatment.
ADT including LHRH agonist and antagonist. ARPIs including Abiraterone Acetate, Enzalutamide, Apalutamide, Darolutamide or Rezvilutamide. Receives: Other: Bone health assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD loss measured at lumbar spine
Measured by bone densitometry
Measured: every 6 months, up to 2 years
BMD loss measured at hip
Measured by bone densitometry
Measured: every 6 months, up to 2 years
Secondary outcomes (2)
trabecular bone score (TBS) changes
Measured by bone densitometry
Measured: every 6 months, up to 2 years
major osteoporotic fracture risk
Estimated by Fracture Risk Assessment Tool (FRAX®)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bianjiang Liu, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838520
- Sponsor's protocol ID
- 2024-SR-999
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bouillon R, Marcocci C, Carmeliet G, Bikle D, White JH, Dawson-Hughes B, Lips P, Munns CF, Lazaretti-Castro M, Giustina A, Bilezikian J. Skeletal and Extraskeletal Actions of Vitamin D: Current Evidence and Outstanding Questions. Endocr Rev. 2019 Aug 1;40(4):1109-1151. doi: 10.1210/er.2018-00126.
PubMed 30321335D'Andrea S, Martorella A, Coccia F, Castellini C, Minaldi E, Totaro M, Parisi A, Francavilla F, Francavilla S, Barbonetti A. Relationship of Vitamin D status with testosterone levels: a systematic review and meta-analysis. Endocrine. 2021 Apr;72(1):49-61. doi: 10.1007/s12020-020-02482-3. Epub 2020 Sep 3.
PubMed 32880851Feng W, Guo J, Li M. RANKL-independent modulation of osteoclastogenesis. J Oral Biosci. 2019 Mar;61(1):16-21. doi: 10.1016/j.job.2019.01.001. Epub 2019 Jan 11.
PubMed 30929797Kokorovic A, So AI, Serag H, French C, Hamilton RJ, Izard JP, Nayak JG, Pouliot F, Saad F, Shayegan B, Aprikian A, Rendon RA. Canadian Urological Association guideline on androgen deprivation therapy: Adverse events and management strategies. Can Urol Assoc J. 2021 Jun;15(6):E307-E322. doi: 10.5489/cuaj.7355. No abstract available.
PubMed 34127184Bhowmik D, Song X, Intorcia M, Gray S, Shi N. Examination of burden of skeletal-related events in patients naive to denosumab and intravenous bisphosphonate therapy in bone metastases from solid tumors population. Curr Med Res Opin. 2019 Mar;35(3):513-523. doi: 10.1080/03007995.2018.1532884. Epub 2018 Nov 20.
PubMed 30286662
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Impact of Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPI) on Bone Loss in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT06838520
- Acronym / sponsor ID
- 2024-SR-999
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- prostate cancer, ADT, ARPI, bone health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Feb 2025 (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.
This study aims to assess the impact of Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPI) on bone quality in patients with prostate cancer. Patients undergoing ADT for prostate cancer often experience adverse effects such as decreased bone density and increased fracture risk. While ARPIs are emerging as novel therapeutic agents, their effects on bone quality remain unclear. This study will compare patients receiving combined ADT and ARPI therapy with those receiving ADT alone, evaluating changes in bone density, bone microarchitecture, and bone metabolic markers. The findings will help optimize treatment strategies for prostate cancer patients, reduce the risk of osteoporosis, and improve overall quality of life.
Detailed description
Prostate cancer is the second most common malignancy in men worldwide and ranks fifth in cancer mortality among men. In developed countries in Europe and America, it has the highest incidence rate. In recent years, with the development of the social economy, increased life expectancy, changes in lifestyle, and improvements in the level of medical and health care, the incidence of prostate cancer in China is gradually rising, posing a serious threat to the life safety of men. In China, more than half of the patients with newly diagnosed prostate cancer have advanced metastatic disease. The skeleton is the most common site of metastasis in these patients. Metastatic lesions may cause pathological fractures and spinal cord compression. Patients with extensive bone metastasis are prone to fatigue, weight loss, anemia, and in severe cases, even systemic organ failure. Hormonal therapy based on ADT remains the main treatment for advanced prostate cancer, with the goal of reducing or eliminating the promoting effect of androgens on cancer cell growth.
While ADT treatment benefits patients with metastatic prostate cancer, it also leads to numerous side effects, such as cardiovascular diseases, changes in body composition, decreased bone mineral density (BMD), hot flashes, gynecomastia, cognitive decline, fatigue, anemia, and sexual dysfunction. ADT treatment can affect the number and function of osteoblasts and osteoclasts through various pathways, disrupting the balance of bone remodeling and leading to cancer treatment-induced bone loss. Under normal conditions, testosterone can be converted to estradiol via aromatase and bind to the estrogen receptors on the surface of osteoclasts, indirectly regulating these cells. With increasing age, the bioactivity of both testosterone and estrogen declines in normal men, resulting in low-turnover bone metabolic changes and a bone loss rate of 0.5% to 1% per year. In patients undergoing ADT, the levels of testosterone and estrogen decrease more significantly, and the number of osteoclasts increases markedly. Moreover, ADT treatment can reduce muscle mass and increase fat, leading to sarcopenic obesity, which is accompanied by chronic low-grade inflammation throughout the body and disrupts bone homeostasis. ADT may also lower the levels of circulating vitamin D, which not only affects bone mineralization but also has adverse effects on skeletal muscle and prostate cancer itself. Studies have shown that after 12 months of ADT treatment, the median lumbar spine BMD in patients decreased by an average of 3.6%, higher than that in untreated elderly men (0.5% to 1%). The BLADE study (NCT03202381) confirmed that long-term ADT treatment with either Gonadotropin-releasing hormone (GnRH) receptor agonists or antagonists significantly reduces bone quality. In fact, bone loss caused by ADT treatment can also lead to skeletal-related events (SREs), represented by pathological fractures, bone radiotherapy, bone surgery, and spinal cord compression.
ARPIs play a crucial role in the treatment of prostate cancer. Prostate cancer cells often rely on androgens for growth, and ARPIs work by blocking the androgen receptor pathway, thereby inhibiting the proliferation of cancer cells. These inhibitors, such as abiraterone, enzalutamide, and apalutamide, have significantly improved outcomes for patients with advanced prostate cancer, including those with metastatic castration-resistant prostate cancer (mCRPC). By reducing the levels of androgens or blocking their effects, ARPIs may also negatively impact bone quality in patients with prostate cancer. These agents, by reducing androgen levels, may lead to decreased BMD and increased fracture risk.
The impact of combining ADT with ARPIs on bone quality remains unclear. While clinical trial data on ARPIs in nonmetastatic castration-resistant prostate cancer (nmCRPC) have shown mixed results regarding bone health. Further research is needed to fully understand the combined effects of ADT and ARPIs on bone quality. It is essential to gain a deeper understanding of the patterns of osteoporosis to provide most effective bone-protective therapies to prevent the occurrence of SREs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: ADT alone | – | Other: Bone health assessmentMen with locally advanced prostate cancer or metastatic hormone-sensitive prostate cancer, about to start treatment. ADT including LHRH agonist and antagonist. |
| Group B: ADT + ARPIs | – | Other: Bone health assessmentMen with locally advanced prostate cancer or metastatic hormone-sensitive prostate cancer, about to start treatment. ADT including LHRH agonist and antagonist. ARPIs including Abiraterone Acetate, Enzalutamide, Apalutamide, Darolutamide or Rezvilutamide. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include male patients with locally advanced or metastatic hormone-sensitive prostate cancer (mHSPC) in mainland China. All patients must have visited the urology or oncology outpatient departments of a tertiary hospital and have a pathological confirmation of the disease.
Key inclusion criteria (6 listed)
- Age ≥ 18 years, male gender;
- Histologically or cytologically confirmed prostate cancer;
- Clinical stage of metastatic hormone-sensitive prostate cancer (mHSPC);
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
- Life expectancy ≥ 12 months;
Key exclusion criteria (8 listed)
- Suffering from double primary malignancies.
- Having previously received androgen deprivation therapy (ADT) or other pharmacological treatments (e.g., denosumab, bisphosphonates, or corticosteroids).
- Having osteoporosis at baseline (T-score ≤ -2.5).
- Having known bone diseases.
- Having spinal metastases confirmed by imaging (e.g., ECT, MRI, CT, or PSMA PET-CT).
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 |
|---|---|---|
| Bone health assessmentAssessments of physical function, DXA scan | Other | Group A: ADT alone, Group B: ADT + ARPIs |
Primary outcome
BMD loss measured at lumbar spine
Time frame: every 6 months, up to 2 years
Measured by bone densitometry
BMD loss measured at hip
Time frame: every 6 months, up to 2 years
Measured by bone densitometry
2 secondary outcomes
trabecular bone score (TBS) changes
Time frame: every 6 months, up to 2 years
major osteoporotic fracture risk
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Background: PubMed 30321335Bouillon R, Marcocci C, Carmeliet G, Bikle D, White JH, Dawson-Hughes B, Lips P, Munns CF, Lazaretti-Castro M, Giustina A, Bilezikian J. Skeletal and Extraskeletal Actions of Vitamin D: Current Evidence and Outstanding Questions. Endocr Rev. 2019 Aug 1;40(4):1109-1151. doi: 10.1210/er.2018-00126.
- Background: PubMed 32880851D'Andrea S, Martorella A, Coccia F, Castellini C, Minaldi E, Totaro M, Parisi A, Francavilla F, Francavilla S, Barbonetti A. Relationship of Vitamin D status with testosterone levels: a systematic review and meta-analysis. Endocrine. 2021 Apr;72(1):49-61. doi: 10.1007/s12020-020-02482-3. Epub 2020 Sep 3.
- Background: PubMed 30929797Feng W, Guo J, Li M. RANKL-independent modulation of osteoclastogenesis. J Oral Biosci. 2019 Mar;61(1):16-21. doi: 10.1016/j.job.2019.01.001. Epub 2019 Jan 11.
- Background: PubMed 34127184Kokorovic A, So AI, Serag H, French C, Hamilton RJ, Izard JP, Nayak JG, Pouliot F, Saad F, Shayegan B, Aprikian A, Rendon RA. Canadian Urological Association guideline on androgen deprivation therapy: Adverse events and management strategies. Can Urol Assoc J. 2021 Jun;15(6):E307-E322. doi: 10.5489/cuaj.7355. No abstract available.
- Background: PubMed 30286662Bhowmik D, Song X, Intorcia M, Gray S, Shi N. Examination of burden of skeletal-related events in patients naive to denosumab and intravenous bisphosphonate therapy in bone metastases from solid tumors population. Curr Med Res Opin. 2019 Mar;35(3):513-523. doi: 10.1080/03007995.2018.1532884. Epub 2018 Nov 20.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Adenocarcinoma), run by The First Affiliated Hospital with Nanjing Medical University at 4 sites in China.
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 6 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: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bianjiang Liu, MD (+8613851493417, bjliu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMD loss measured at lumbar spine (time frame: every 6 months, up to 2 years). The study lists 2 primary outcomes in all. 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 NCT06838520, which also lists 5 linked publications.
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 20 Feb 2025.