Phase 3 Prostate Cancer Trial, Recruiting NCT05838716 Sponsor: University of Rochester Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT05838716
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with Stage I to Stage IV prostate cancer that has not spread to the bones (involvement of lymph nodes is allowed, and a previous diagnosis of another cancer is also allowed)
  • People aged 50 years or older
  • People who are about to start, or have recently started, a hormone treatment called ADT (androgen deprivation therapy) within the past 6 months, with at least 6 months of that treatment planned in total
  • People whose blood vitamin D level falls between 10 and 32 ng/ml (a specific range checked by a blood test)
  • People whose blood calcium level is 10.5 mg/dl or below
  • People whose kidneys are functioning at a normal filtering rate (a blood test result above 30 ml/min)
  • People who agree not to take their own calcium or vitamin D supplements during the trial, other than those supplied by the study
  • People who are able to give written consent to participate
  • People who are able to swallow pills and capsules
  • People who are able to speak and read English

Who may not be able to join:

  • People who have used bone-strengthening medications (such as bisphosphonates, denosumab, or teriparatide) for more than 3 months before joining the trial
  • People who have been diagnosed with Stage IV (late-stage) chronic kidney disease
  • People whose blood calcium level is above 11.5 mg/dl (a condition called high-grade hypercalcemia)
  • People who have a history of abnormally high calcium levels, or who have previously had a bad reaction to or poisoning from vitamin D

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
14 December 2023
Est. completion
29 April 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Reduction of bone mineral density (BMD) loss as measured at the total hip; Reduction of BMD loss as measured at the femoral neck; Reduction of BMD loss as measured at the distal radius; Reduction of BMD loss as measured at the lumbar spine

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov