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Arm I (HDVD) for Prostate Cancer

Phase 3

Recruiting

Led By Luke J Peppone

Research Sponsored by University of Rochester NCORP Research Base

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 52 weeks

Awards & highlights

Study Summary

This trial is testing whether high-dose vitamin D can help treat bone loss in prostate cancer patients who are undergoing androgen-deprivation therapy. Vitamin D is important for the body to absorb calcium, which

Who is the study for?

This trial is for men aged 60 or older with Stage I-IV prostate cancer, starting androgen-deprivation therapy (ADT) without bone metastases. Participants must have started ADT within the last 3 months, plan to continue it for at least another 6 months, have specific levels of vitamin D and calcium in their blood, normal kidney function, and not take other calcium/vitamin D supplements.Check my eligibility

What is being tested?

The study tests if high-dose vitamin D can prevent bone loss caused by ADT in older prostate cancer patients. It involves taking either high-dose vitamin D or a placebo while undergoing regular assessments like bone scans and quality-of-life surveys to see if there's an improvement in bone health, reduction in falls, or less fatigue.See study design

What are the potential side effects?

Potential side effects from high doses of vitamin D may include elevated blood calcium levels which could cause confusion, digestive issues like nausea or vomiting; increased urination; weakness; and potential heart rhythm problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have prostate cancer stages I-IV without bone spread, but lymph nodes may be involved.

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I am 60 years old or older.

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I agree to only take calcium and vitamin D supplements given by the study.

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My kidney function is normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction of BMD loss as measured at the lumbar spine

Reduction of bone mineral density (BMD) loss as measured at the total hip

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (HDVD)Experimental Treatment5 Interventions

Patients receive HDVD PO throughout the study. Patients also undergo collection of blood and DXA scan on study.

Group II: Arm II (placebo, DXA scan, blood collection, questionnaire)Placebo Group5 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Dual X-ray Absorptiometry

2015

N/A

~50

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Rochester NCORP Research BaseLead Sponsor

13 Previous Clinical Trials

8,777 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,075 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

Luke J PepponePrincipal InvestigatorUniversity of Rochester NCORP Research Base

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential candidates able to apply for participation in this ongoing trial?

"Indeed, based on the information available on clinicaltrials.gov, this trial is actively seeking eligible participants. It was originally posted on December 14th, 2023 and last updated on January 16th, 2024."

Answered by AI

Has the Food and Drug Administration (FDA) given their approval for Arm I, also known as HDVD?

"Based on the designation of this trial as a Phase 3 study, indicating previous evidence supporting safety and efficacy, our team at Power rates Arm I (HDVD) with a safety score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Luke Peppone 2023. "High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05838716.