Vitamin D for Prostate Endocrine Therapy

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 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

Interventions

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

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Rochester

  lead OTHER

Principal Investigators

• Luke J Peppone · University of Rochester NCORP Research Base

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-14

Primary Completion

2029-04-29

Completion

2029-04-29

Countries

• United States

Study Locations