Targeting Bone Health in Men with Prostate Cancer Using High-Dose Vitamin D

Recruiting · Phase 3 · Stage I Prostate Cancer AJCC v8 and related conditions · 14 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This clinical trial studies how high-dose vitamin D may help men with prostate cancer who are receiving treatment that lowers hormone levels. These treatments can lead to bone loss, and vitamin D is important for strong bones. Researchers want to see if taking high-dose vitamin D can help keep bones healthy, reduce falls, and improve energy levels in these patients.

This is a Phase 3 trial, which means it is looking at how well the treatment works and its safety. The trial hopes to include about 240 participants. It is not regulated by the FDA for drugs or devices.

Who can join

Men aged 50 and older diagnosed with Stage I-IV prostate cancer without bone spread can join. Participants should be starting or have recently begun hormone therapy for prostate cancer. They must have certain vitamin and calcium levels and agree not to take other supplements during the study. The trial team will confirm eligibility.

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

Age group

Adult, Older adult

Sex

Male

The study team makes the final call on eligibility.

What happens in the study

Participants will be placed into one of two groups by chance. One group will take high-dose vitamin D once a week for a year. The other group will take a placebo, which looks like the vitamin but has no active ingredient, also once a week for a year. All participants will have blood tests and scans to measure bone health throughout the study.