Vitamin D for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Must not be taking: Vitamin D, Multivitamins

Disqualifiers: Hypersensitivity to vitamin D, Dialysis, Cirrhosis, Hypercalcemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the prevalence of low vitamin D levels in African American men with a history of prostate cancer, regardless of whether the cancer has spread. It examines how low vitamin D might affect the immune system and whether taking vitamin D can address this issue. The study focuses on using cholecalciferol (a type of vitamin D) as a treatment. Men with a history of prostate cancer and low vitamin D levels might be suitable candidates for this study. As an Early Phase 1 trial, this research aims to understand how cholecalciferol works in people, offering participants a chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've been taking a vitamin D or multivitamin supplement with more than 400 IU of vitamin D daily for the past month.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that cholecalciferol, a type of vitamin D, is generally safe for use. Studies have explored the relationship between vitamin D levels and prostate cancer, suggesting that higher vitamin D levels might be linked to lower death rates in prostate cancer patients. Although strong evidence does not support that vitamin D directly lowers the risk of developing prostate cancer, it is usually well-tolerated.

Earlier research on prostate cancer patients studied cholecalciferol supplements to assess their safety. This research remains in the early stages, focusing on how the body processes the treatment and ensuring it causes no harm. Researchers carefully monitor participants for any side effects during this phase.

Overall, cholecalciferol has been widely used in various situations, and its safety is well-known. Participants in this trial will be closely monitored to address any potential side effects promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional prostate cancer treatments such as surgery, radiation, or hormone therapy, cholecalciferol (Vitamin D3) is being explored for its potential to address vitamin D deficiency in patients. Researchers are excited about cholecalciferol because it is a simple vitamin supplement that may help support immune function and potentially slow cancer progression. The idea is that by boosting vitamin D levels, patients might experience benefits with minimal side effects compared to more aggressive treatments.

What evidence suggests that cholecalciferol might be an effective treatment for prostate cancer?

Research has shown that vitamin D3, also known as cholecalciferol, can positively affect prostate cancer. Studies have found that taking vitamin D3 can slightly lower PSA levels, indicators of prostate cancer activity, suggesting slower cancer growth. One study indicated that vitamin D3 could benefit individuals with early-stage, low-risk prostate cancer. Additionally, vitamin D3 might reduce the risk of developing advanced cancer in those without a cancer diagnosis. These findings suggest that vitamin D3 could play a helpful role in treating prostate cancer. Participants in this trial will receive cholecalciferol to further evaluate its effects on prostate cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Gerardo Colon-Otero

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for African American males aged 18 or older with a history of localized or metastatic prostate cancer and low vitamin D levels. They must be willing to visit the Mayo Clinic for blood collection at the start and after 8 weeks. Those with hypercalcemia, end-stage renal failure, current high-dose vitamin D intake, recent chemotherapy/surgery/radiation, hypersensitivity to vitamin D, liver cirrhosis, or legal/medical issues affecting consent are excluded.

Inclusion Criteria

I have had prostate cancer before, whether it was localized, spread, or came back.

I am an African American male aged 18 or older.

Patients with Vitamin D levels below 30 ng/mL

Exclusion Criteria

I have been taking vitamin D or a multivitamin with over 400 IU of vitamin D daily for the last month.

I am on dialysis for end-stage kidney failure.

I have liver cirrhosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants with low vitamin D3 levels receive cholecalciferol orally daily for 8 weeks. Blood samples are collected throughout the study.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on progression free survival and immune response.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Cholecalciferol

Trial Overview The study investigates how common vitamin D insufficiency is among Black/African American prostate cancer patients and its effect on immune function. It also examines whether supplementing with cholecalciferol (vitamin D) normalizes immune responses. Participants will undergo quality-of-life assessments as part of the study.

How Is the Trial Designed?

Group I: Treatment (cholecalciferol) Experimental Treatment 3 Interventions

Patients with low vitamin D3 levels receive cholecalciferol PO daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.

Cholecalciferol is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as Vitamin D3 for:

• Prevention and treatment of vitamin D deficiency
• Osteoporosis prevention
• Rickets prevention

Approved in European Union as Cholecalciferol for:

• Prevention and treatment of vitamin D deficiency
• Osteoporosis prevention
• Rickets prevention

Approved in Canada as Vitamin D3 for:

• Prevention and treatment of vitamin D deficiency
• Osteoporosis prevention
• Rickets prevention

Approved in Japan as Cholecalciferol for:

• Prevention and treatment of vitamin D deficiency
• Osteoporosis prevention
• Rickets prevention

Approved in China as Vitamin D3 for:

• Prevention and treatment of vitamin D deficiency
• Osteoporosis prevention
• Rickets prevention

Approved in Switzerland as Cholecalciferol for:

• Prevention and treatment of vitamin D deficiency
• Osteoporosis prevention
• Rickets prevention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Oral vitamin D3 supplementation significantly increased levels of calcitriol and other vitamin D metabolites in prostate tissue, especially at the highest dose of 40,000 IU/d, indicating a dose-dependent effect.

While the study did not find significant differences in Ki67 expression (a marker of cell proliferation) among the different vitamin D doses, higher calcitriol levels were associated with lower Ki67 intensity, suggesting potential benefits in reducing prostate cancer cell activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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., et al.[2023]

In a study of 26 patients with asymptomatic, PSA-progressive prostate cancer, vitamin D therapy was found to be effective, with 20% of patients showing a significant reduction in PSA levels by an average of 45.3% after 3 months.

The treatment was well tolerated, with no adverse effects on serum calcium levels, and some patients experienced stabilization of PSA levels for up to 36 months, indicating its potential as a valuable addition to prostate cancer treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The promiscuous receptor. Newsom-Davis, TE., Kenny, LM., Ngan, S., et al.[2009]

Sustained delivery of 1alpha,25-dihydroxyvitamin D(3) (1,25 D(3)) significantly reduced the formation of prostate intraepithelial neoplasia (PIN) in Nkx3.1; Pten mutant mice, indicating its potential as a chemopreventive agent against prostate cancer.

The study suggests that 1,25 D(3) is most effective when administered before the onset of PIN, highlighting the importance of timing in treatment for better outcomes in early-stage prostate cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D inhibits the formation of prostatic intraepithelial neoplasia in Nkx3.1;Pten mutant mice. Banach-Petrosky, W., Ouyang, X., Gao, H., et al.[2016]

Vitamin D signaling is biologically active and may play a significant role in the development and prognosis of prostate cancer, suggesting it could be a target for prevention and treatment.

Current clinical data supporting the use of vitamin D compounds in prostate cancer management is limited, highlighting the need for large-scale clinical trials to explore their efficacy based on promising preclinical findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D in prostate cancer. Trump, DL., Aragon-Ching, JB.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediagnostic plasma vitamin D metabolites and mortality among patients with prostate cancer. Fang, F., Kasperzyk, JL., Shui, I., et al.[2022]

Oral vitamin D3 supplementation significantly increased levels of calcitriol and other vitamin D metabolites in prostate tissue, especially at the highest dose of 40,000 IU/d, without adverse effects on safety measures.

While Ki67 expression, a marker of cell proliferation, did not differ significantly among the vitamin D dose groups, higher levels of calcitriol were inversely associated with Ki67 intensity, suggesting potential benefits in reducing prostate cancer cell proliferation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]. Olumi, AF.[2018]

Vitamin D supplementation, particularly with calcitriol at doses of 250-1000 mg for 3-8 weeks or 45 mg for 18.3 months, may help reduce prostate-specific antigen (PSA) levels and improve survival in prostate cancer patients, based on a review of 8 high-quality randomized controlled trials.

While some studies showed positive effects on PSA and survival, many others reported no significant impact, indicating that more research is needed to fully understand the role of vitamin D in prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Vitamin D Supplementation in Prostate Cancer: A Systematic Review of Randomized Control Trials. Petrou, S., Mamais, I., Lavranos, G., et al.[2019]

Vitamin D receptors (VDR) are present in various human prostate cancer cell lines and primary cultures, indicating that vitamin D may play a role in prostate cancer biology.

The active form of vitamin D, 1,25-D, has been shown to inhibit cell growth and stimulate PSA production in prostate cells, suggesting its potential as a therapeutic agent for chemoprevention and differentiation therapy in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D and prostate cancer. Feldman, D., Skowronski, RJ., Peehl, DM.[2019]

The active form of vitamin D, 1,25(OH)2D, significantly alters gene expression in non-tumorigenic prostate cells, with thousands of transcripts changing in response to treatment, indicating its potential role in prostate cancer prevention.

Vitamin D appears to suppress key cancer-related signaling pathways (like WNT and NF-kB) and pro-inflammatory responses, while promoting protective mechanisms against oxidative stress, suggesting a multifaceted approach to limiting prostate cancer development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1,25 dihydroxyvitamin D-mediated orchestration of anticancer, transcript-level effects in the immortalized, non-transformed prostate epithelial cell line, RWPE1. Kovalenko, PL., Zhang, Z., Cui, M., et al.[2022]

In a study of 15 patients with rising PSA levels after local prostate cancer treatments, daily administration of 2,000 IU of cholecalciferol (vitamin D) led to decreased or stable PSA levels in 9 patients for up to 21 months.

Cholecalciferol significantly prolonged the median PSA doubling time from 14.3 months to 25 months, with no reported side effects, suggesting it may be a safe and effective option for managing PSA levels in prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study: potential role of vitamin D (Cholecalciferol) in patients with PSA relapse after definitive therapy. Woo, TC., Choo, R., Jamieson, M., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6240137/

Circulating vitamin D level and mortality in prostate cancer ... Several randomized clinical trials showed that oral vitamin D3 modestly decreased the level of PSA (55) and reduced the PSA rise rate (56, 57). However, a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01759771

Vitamin D3 Supplementation for Low-Risk Prostate Cancer ... The results of the investigators' clinical studies indicate that vitamin 1,25 dihydroxyvitamin D3 (VD3) supplementation results in a decrease of positive cancer ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960076012002452

Vitamin D3 supplementation, low-risk prostate cancer, and ... The results of this clinical study suggest that supplementation with vitamin D 3 at 4000 IU per day may benefit patients with early stage, low-risk prostate ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e17096

Vitamin D deficiency in prostate cancer: Prevalence in a ... Median vitamin D level was 35.4 ng/mL at time of prostate cancer diagnosis. Deficiency rates were highest among Hispanic (31.8%) and Black (33.3 ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2773074

Effect of Vitamin D3 Supplements on Development ... These findings suggest that vitamin D 3 may reduce the risk of developing advanced cancer among adults without a diagnosis of cancer at baseline.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10915943/

Unlocking the potential-vitamin D in prostate cancer ... Emerging evidence suggests a link between vitamin D deficiency and increased prostate cancer risk, especially in regions with limited sunlight ...

7. cancer.gov cancer.gov/about-cancer/causes-prevention/risk/diet/vitamin-d-fact-sheet

Vitamin D and Cancer - NCI A collaborative analysis of individual participant data from 19 prospective studies assesses circulating Vitamin D and prostate cancer risk.

8. wcrf.org wcrf.org/research-policy/our-research/grants-database/vitamin-d-and-prostate-cancer/

Vitamin D and prostate cancer Key findings​​ We found that studies to date report no strong evidence of an association of vitamin D exposure with prostate cancer risk, although there were too ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00524680

Vitamin D in Treating Patients With Prostate Cancer Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.