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Vitamin D for Prostate Endocrine Therapy

Study acronym: ViPER
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Lead sponsor: University of Rochester NCORP Research Base to University of Rochesterv7 Show 6 more changesShow less
    • Enrollment target: 366 to 240
    • Primary and study completion dates: Jul 29, 2032 to Apr 29, 2029
    • Study sites: 46 to 51
    • Eligibility criteria revised
    • Study description shortened, about 21 words
    • Study title shortened, about 7 words
  2. Primary completion date: May 31, 2026 to Jul 29, 2032v6 Show 6 more changesShow less
    • Primary endpoints: 2 to 4
    • Study sites: 1 to 46
    • Study completion date: May 31, 2027 to Jul 29, 2032
    • Secondary endpoints expanded, about 11 words
    • Study description shortened, about 11 words
    • Eligibility criteria expanded, about 5 words
  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 29, 2023 to Dec 14, 2023
    v4
  5. Start date: Oct 5, 2023 to Dec 29, 2023v3
  6. Start date: Aug 5, 2023 to Oct 5, 2023v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05838716
Lead Sponsor University of Rochester
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov