NCT05838716 Vitamin D for Prostate Endocrine Therapy
| NCT ID | NCT05838716 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Rochester |
| Condition | Stage I Prostate Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-12-14 |
| Primary Completion | 2029-04-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 240 participants in total. It began in 2023-12-14 with a primary completion date of 2029-04-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 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 are permitted) * 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 Exclusion Criteria: * 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
Contact & Investigator
Luke J Peppone
PRINCIPAL INVESTIGATOR
University of Rochester NCORP Research Base
Frequently Asked Questions
Who can join the NCT05838716 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Stage I Prostate Cancer AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05838716 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 240 participants.
Is NCT05838716 currently recruiting?
Yes, NCT05838716 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Rochester to inquire about joining.
Where is the NCT05838716 trial being conducted?
This trial is being conducted at Newark, United States, Newark, United States, Danville, United States, Decatur, United States and 11 additional locations.
Who is sponsoring the NCT05838716 clinical trial?
NCT05838716 is sponsored by University of Rochester. The principal investigator is Luke J Peppone at University of Rochester NCORP Research Base. The trial plans to enroll 240 participants.
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