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New treatment option for Stage I Prostate Cancer AJCC v8
Official title Vitamin D for Prostate Endocrine Therapy
ClinicalTrials.gov ID: NCT05838716
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, men only
You may be able to join if
- 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 50 years or older
- Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at least 6 planned months of treatment (both...
- Have a total serum vitamin D between 10 and 32 ng/ml
- Have a total serum calcium of less than or equal to 10.5 mg/dl
You likely can't join if
- Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (IV)...
- Have a diagnosis of stage IV chronic kidney disease
- Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg/dl)
- Have a history of hypercalcemia or vitamin D toxicity/sensitivity
See the full eligibility 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 50 years or older
- Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone [LHRH] antagonists and LHRH agonists...
- Have a total serum vitamin D between 10 and 32 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
- Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (IV) bisphosphonates, denosumab, or teriparatide prior to enrollment
- Have a diagnosis of stage IV chronic kidney disease
- Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg/dl)
- Have a history of hypercalcemia or vitamin D toxicity/sensitivity
The study team makes the final eligibility decision.
Where it's taking place
- Newark, Delaware, United States
- Danville, Illinois, United States
- Decatur, Illinois, United States
- Effingham, Illinois, United States
- Mattoon, Illinois, United States
- O'Fallon, Illinois, United States
- Urbana, Illinois, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Topeka, Kansas, United States
- Westwood, Kansas, United States
- New Orleans, Louisiana, United States
- Coon Rapids, Minnesota, United States
- Maplewood, Minnesota, United States
- Saint Louis Park, Minnesota, United States
- Saint Paul, Minnesota, United States
- Waconia, Minnesota, United States
- Kansas City, Missouri, United States
- Lee's Summit, Missouri, United States
- St Louis, Missouri, United States
+ 22 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, Delaware, United States; Danville, Illinois, United States; Decatur, Illinois, United States; Effingham, Illinois, United States; Mattoon, Illinois, United States; O'Fallon, Illinois, United States and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.