Vitamin D for Prostate Endocrine 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 Criteria

Sex

MALE

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood
• D Vitamin — DIETARY_SUPPLEMENT
  Given PO
• Dual X-ray Absorptiometry — PROCEDURE
  Undergo DXA scan
• Placebo Administration — DRUG
  Given PO
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Dec 14, 2023

Status verified

Jan 2026

Primary completion

Apr 29, 2029

Completion

Apr 29, 2029

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm I (HDVD)
  Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
• Placebo Comparator: Arm II (placebo)
  Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.

Primary Outcome Measure

Reduction of bone mineral density (BMD) loss as measured at the total hip [ Time Frame: At 52 weeks ]

Locations (51)

Find similar trials in Newark, DE

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