366 Participants Needed

High-Dose Vitamin D for Bone Loss in Prostate Cancer

Recruiting at 45 trial locations
OT
BB
Overseen ByBrooke Burgess, MS
Age: 18+
Sex: Male
Trial Phase: Phase 3
Sponsor: University of Rochester NCORP Research Base
Must be taking: LHRH antagonists, LHRH agonists
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for this trial?

The trial requires that you stop taking any calcium and vitamin D supplements other than those provided by the study. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is high-dose vitamin D safe for humans?

High doses of vitamin D, particularly in the form of 1,25-dihydroxyvitamin D3, can lead to hypercalcemia (high calcium levels in the blood), which is a safety concern. However, strategies like pulse dosing and using less calcemic analogs have been explored to reduce this risk in clinical trials.12345

How is high-dose vitamin D treatment different for prostate cancer?

High-dose vitamin D treatment for prostate cancer is unique because it leverages the ability of prostate cells to locally produce the active form of vitamin D, calcitriol, which can help slow cancer cell growth. Unlike other treatments, it focuses on enhancing the body's natural vitamin D metabolism to exert anti-cancer effects, although the risk of high calcium levels in the blood (hypercalcemia) is a concern.12356

What data supports the effectiveness of the treatment High-Dose Vitamin D for Bone Loss in Prostate Cancer?

Research suggests that vitamin D, including forms like cholecalciferol (vitamin D3), may help prostate cancer patients because prostate cells can convert it into an active form that might slow cancer growth. Additionally, vitamin D has shown potential benefits in preventing prostate cancer and improving outcomes, although more research is needed to confirm its effectiveness specifically for bone loss in prostate cancer patients.12378

Who Is on the Research Team?

LJ

Luke J Peppone, PhD

Principal Investigator

University of Rochester NCORP Research Base

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have prostate cancer stages I-IV without bone spread, but lymph nodes may be involved.
I am 60 years old or older.
I recently started or will start hormone therapy for my cancer, with at least 6 months of treatment ahead.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-dose vitamin D or placebo orally throughout the study, with blood collection and DXA scans conducted

52 weeks
Regular visits for blood collection and DXA scans

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • D Vitamin
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (HDVD)Experimental Treatment5 Interventions
Group II: Arm II (placebo)Placebo Group5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester NCORP Research Base

Lead Sponsor

Trials
14
Recruited
9,100+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 120 men with recurrent prostate cancer and 50 with localized prostate cancer, vitamin D deficiency was found to be common, with 40% of men with recurrent disease and 18% of those with localized disease having levels below 20 ng/mL.
The study also revealed that factors such as metastatic disease and the season of blood sampling were linked to vitamin D deficiency, highlighting the need for monitoring vitamin D levels in prostate cancer patients.
Vitamin D deficiency and insufficiency among patients with prostate cancer.Trump, DL., Chadha, MK., Sunga, AY., et al.[2022]
Vitamin D, particularly its active form 1,25(OH)(2)D, has shown promising effects in preventing and treating prostate cancer by promoting cell differentiation and inhibiting cancer cell growth, based on its ability to act on prostate cells that have receptors for this hormone.
While vitamin D may help prevent prostate cancer, existing tumors may require treatment with 1,25(OH)(2)D or its analogs, though the risk of hypercalcemia remains a challenge that researchers are addressing through various dosing strategies in clinical trials.
Vitamin D and intervention trials in prostate cancer: from theory to therapy.Schwartz, GG.[2018]
In a study of 1822 prostate cancer patients, higher prediagnostic levels of 25(OH) vitamin D were associated with lower total mortality and a reduced risk of dying from prostate cancer, suggesting a potential link between vitamin D levels and cancer prognosis.
No significant association was found between 1,25(OH)(2)D levels and mortality, indicating that the benefits observed may be specifically related to 25(OH)D, particularly in patients diagnosed within five years.
Prediagnostic plasma vitamin D metabolites and mortality among patients with prostate cancer.Fang, F., Kasperzyk, JL., Shui, I., et al.[2022]

Citations

Vitamin D deficiency and insufficiency among patients with prostate cancer. [2022]
Vitamin D and intervention trials in prostate cancer: from theory to therapy. [2018]
Prediagnostic plasma vitamin D metabolites and mortality among patients with prostate cancer. [2022]
Randomized clinical trial of vitamin D3 doses on prostatic vitamin D metabolite levels and ki67 labeling in prostate cancer patients. [2023]
Commentary on "randomized clinical trial of vitamin D3 doses on prostatic vitamin D metabolite levels and Ki67 labeling in prostate cancer patients." Wagner D, Trudel D, Van der Kwast T, Nonn L, Giangreco AA, Li D, Dias A, Cardoza M, Laszlo S, Hersey K, Klotz L, Finelli A, Fleshner N, Vieth R, Department of Nutritional Sciences, University of Toronto, Ontario, Canada.: J Clin Endocrinol Metab 2013;98(4):1498-507 [Epub 2013 Mar 5]. [2018]
Vitamin D inhibition of prostate adenocarcinoma growth and metastasis in the Dunning rat prostate model system. [2013]
Vitamin D receptor-dependent antitumour effects of 1,25-dihydroxyvitamin D3 and two synthetic analogues in three in vivo models of prostate cancer. [2019]
Determinants of vitamin D levels in men receiving androgen deprivation therapy for prostate cancer. [2015]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security