Effect of ADT and ARPI on Bone Loss of Patients with Prostate Cancer

NCT06838520 | Not Yet Recruiting

• 1 other identifier: 2024-SR-999
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

prostate cancer; ADT; ARPI; bone health

Outcome Measures

Primary Outcomes (2)

• BMD loss measured at lumbar spine

  Measured by bone densitometry

  every 6 months, up to 2 years

• BMD loss measured at hip

  Measured by bone densitometry

  every 6 months, up to 2 years

Secondary Outcomes (2)

• trabecular bone score (TBS) changes

  every 6 months, up to 2 years

• major osteoporotic fracture risk

  24 months

Study Arms (2)

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.

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.

Other: Bone health assessment

Interventions

Bone health assessment OTHER

Assessments of physical function, DXA scan

Group A: ADT alone; Group B: ADT + ARPIs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (4)

The Third Affiliated Hospital of Soochow University

Changzhou, Jiangsu, 213004, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210009, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225009, China

Location

Related Publications (5)

• 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.

  PMID: 30321335 BACKGROUND

• D'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.

  PMID: 32880851 BACKGROUND

• Feng 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.

  PMID: 30929797 BACKGROUND

• Kokorovic 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.

  PMID: 34127184 BACKGROUND

• Bhowmik 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.

  PMID: 30286662 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Bianjiang Liu, MD

CONTACT

+8613851493417; bjliu@njmu.edu.cn

Ruizhe Zhao, MD

CONTACT

+8615251840611; drzrzurology@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 20, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

CN (4)