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NCT05838716RECRUITINGIRB Ready

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

Sponsored by University of Rochester NCORP Research Base

Quick Self-Assessment

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

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
Be starting ADT or have received their first ADT treatment in the past 3 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone \[LHRH\] antagonists and LHRH agonists are permitted)
Have a total serum vitamin D between 10 and 27 ng/ml
Have a total serum calcium of less than or equal to 10.5 mg/dl
Have a normal GFR (glomerular filtration rate \> 30ml)
Agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided by the study
Be able to provide written informed consent
Be able to swallow pills and capsules
Be able to speak and read English

Exclusion Criteria

Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

366 participants

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Gender

MALE

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Sponsor

University of Rochester NCORP Research Base

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Newark

Delaware

Location available
View Newark location page
RECRUITING

Newark

Delaware

Location available
View Newark location page
RECRUITING

Danville

Illinois

Location available
View Danville location page
RECRUITING

Decatur

Illinois

Location available
View Decatur location page
RECRUITING

Effingham

Illinois

Location available
View Effingham location page
RECRUITING

Mattoon

Illinois

Location available
View Mattoon location page
RECRUITING

O'Fallon

Illinois

Location available
View O'Fallon location page
RECRUITING

Urbana

Illinois

Location available
View Urbana location page
RECRUITING

Kansas City

Kansas

Location available
View Kansas City location page

๐Ÿ“ And 42 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Prostate Cancer Treatment in Newark?

Join others in Delaware exploring innovative treatment options through clinical research

Prostate Cancer Treatment Options in Newark, Delaware

If you're searching for Prostate Cancer treatment in Newark, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Newark, Newark, Danville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Prostate Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Delaware
Now Enrolling
Up to 366 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Prostate Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Prostate Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Prostate Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05838716. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.