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

Purpose

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 researchers determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.

Conditions

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

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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 a total of at least 6 planned months of treatment (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 a total serum calcium of less than or equal to 10.5 mg/dl - Have a normal GFR (glomerular filtration rate > 30ml) - 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 intravenous (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 11.5 mg/dl) - Have a history of hypercalcemia or vitamin D toxicity/sensitivity

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)
Masking Description
Participants, study coordinators, and investigators will be blinded to high-dose vitamin D or placebo group assignments.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm I (HDVD) 		Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
  • Procedure: Biospecimen Collection
    Undergo collection of blood
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Dietary Supplement: D Vitamin
    Given PO
    Other names:
    • 3-[2-[7a-methyl-1-(1,4,5-trimethylhex-2-enyl)-1,2,3,3a,5,6,7,7a-octahydroinden-4-ylidene]ethylidene]-4-methylidene-cyclohexan-1-ol
    • Vitamin D
    • Vitamin D Compound
    • Vitamin-D
  • Procedure: Dual X-ray Absorptiometry
    Undergo DXA scan
    Other names:
    • BMD scan
    • bone mineral density scan
    • DEXA
    • DEXA (Bone Density)
    • DEXA Scan
    • dual energy x-ray absorptiometric scan
    • Dual Energy X-ray Absorptiometry
    • Dual X-Ray Absorptometry
    • DXA
    • DXA SCAN
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Placebo Comparator
Arm II (placebo) 		Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
  • Procedure: Biospecimen Collection
    Undergo collection of blood
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Dual X-ray Absorptiometry
    Undergo DXA scan
    Other names:
    • BMD scan
    • bone mineral density scan
    • DEXA
    • DEXA (Bone Density)
    • DEXA Scan
    • dual energy x-ray absorptiometric scan
    • Dual Energy X-ray Absorptiometry
    • Dual X-Ray Absorptometry
    • DXA
    • DXA SCAN
  • Drug: Placebo Administration
    Given PO
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - North
Kansas City, Missouri 64154
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Rochester NCORP Research Base

Study Contact

Brooke Burgess, MS
585-274-2346
URCC_22053@urmc.rochester.edu

Detailed 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 bone biomarkers measured by Millipore Luminex/enzyme-linked immunosorbent assay (ELISA) assays from serum. II. 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, patients are randomized to 1 of 2 arms. ARM I: Patients receive HDVD orally (PO) once a week (QW) for 52 weeks. Patients also undergo collection of blood and DXA scan on study. ARM II: Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.