High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

Stage IVA Prostate Cancer AJCC v8 Clinical Trial

Official title:

High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838716
• Other study ID #: URCC-22053
• Secondary ID: NCI-2022-07664UR
• Status: Recruiting
• Phase: Phase 3
• Start date: December 14, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: January 2024
• Source: University of Rochester
• Contact: Olivia Tauriello
• Phone: 585-275-8507
• Email: Olivia_Tauriello[@]URMC.Rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can lead to bone diseases such as osteoporosis or rickets. This trial may help researcher determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.

Description:

PRIMARY OBJECTIVES:

I. To evaluate the effect of high-dose vitamin D (HDVD) supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the total hip over 52 weeks as measured by dual-energy x-ray absorptiometry (DXA).

II. To evaluate the effect of HDVD supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the femoral neck, distal radius, and lumbar spine (L1-L4) over 52 weeks as measured by DXA.

SECONDARY OBJECTIVES:

I. To evaluate the effect of HDVD supplementation on falls over 52 weeks as measured by the Falls History questionnaire.

II. To evaluate the effect of HDVD supplementation on fractures over 52 weeks as determined by the Clinical Record Information - Follow-up Form.

III. To evaluate the effect of HDVD supplementation on quality of life over 52 weeks as measured by the Functional Assessment of Cancer Therapy- Prostate (FACT-P).

EXPLORATORY OBJECTIVES:

I. To explore the effect of HDVD supplementation on skeletal muscle mass as measured by DXA.

II. To explore the effect of HDVD supplementation on bone biomarkers measured by Millipore Luminex/enzyme-linked immunosorbent assay (ELISA) assays from serum.

III. To evaluate the effect of HDVD supplementation on pain, fatigue, sleep, and activities of daily living over 52 weeks as measured by patient-reported outcomes.

OUTLINE: After undergoing collection of blood and DXA scan, patents are randomized to 1 of 2 arms.

ARM I: Patients receive HDVD orally (PO) throughout the study. Patients also undergo collection of blood and DXA scan on study.

ARM II: Patients receive placebo PO throughout the study. Patients also undergo collection of blood and DXA scan on study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed)

• Be age 60 years or older

• Be starting ADT or have received their first ADT treatment in the past 3 months, with at least 6 planned months of treatment remaining (both luteinizing hormone-releasing hormone (LHRH) antagonists and LHRH agonists are permitted)

• Have a total serum vitamin D between 10 and 27 ng/ml

• Have an total serum calcium of less than or equal to 10.5 mg/dl

• Have a normal GFR (glomerular filtration rate)

• Agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided by the study

• Be able to provide written informed consent

• Be able to swallow pills and capsules

• Be able to speak and read English

Exclusion Criteria:

• Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or IV bisphosphonates, denosumab, or teriparatide prior to enrollment

• Have a diagnosis of stage IV chronic kidney disease

• Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 10.5 mg/dl)

• Have a history of hypercalcemia or vitamin D toxicity/sensitivity

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood

Dietary Supplement:
• D Vitamin
Given PO

Procedure:
• Dual X-ray Absorptiometry
Undergo DXA scan

Drug:
• Placebo Administration
Given PO

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ochsner Medical Center Jefferson	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester NCORP Research Base	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of bone mineral density (BMD) loss as measured at the total hip	Will determine the efficacy of high-dose vitamin D (HDVD) supplementation versus placebo in reducing BMD loss as measured at the total via dual-energy x-ray absorptiometry (DXA) at 52 weeks. Will use analysis of variance (ANCOVA) with Group (vitamin D or placebo) as the main factor, baseline BMD as covariate, and T3 (week 52) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial linear mixed model (LMM) will be fit using Restricted Maximum Likelihood (REML) estimation. The significance of the variance due to study site will be tested using the Wald Test.	At 52 weeks
Primary	Reduction of BMD loss as measured at the lumbar spine	Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the lumbar spine total via DXA at 52 weeks. Will use ANCOVA with Group (vitamin D or placebo) as the main factor, baseline BMD as covariate, and T3 (week 52) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial LMM will be fit using REML estimation. The significance of the variance due to study site will be tested using the Wald Test.	At 52 weeks