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Targeting Bone Health in Men with Prostate Cancer Using High-Dose Vitamin D

NCT05838716 · Recruiting
About this trial

This clinical trial studies how high-dose vitamin D may help men with prostate cancer who are receiving treatment that lowers hormone levels. These treatments can lead to bone loss, and vitamin D is important for strong bones. Researchers want to see if taking high-dose vitamin D can help keep bones healthy, reduce falls, and improve energy levels in these patients.

Locations and contact

This trial is running at 51 locations in the United States. All of them are currently recruiting.

United States51 locations · 51 recruiting
  • Adena Regional Medical CenterChillicothe, OhioRecruiting
  • Ballad Health Cancer Care - BristolBristol, VirginiaRecruiting
  • Ballad Health Cancer Care - KingsportKingsport, TennesseeRecruiting
  • Bon Secours Cancer Institute at Reynolds CrossingRichmond, VirginiaRecruiting
  • Bon Secours Memorial Regional Medical CenterMechanicsville, VirginiaRecruiting
  • Bon Secours Saint Francis Medical CenterMidlothian, VirginiaRecruiting
  • Bon Secours Saint Mary's HospitalRichmond, VirginiaRecruiting
  • Cancer Care Center of O'FallonO'Fallon, IllinoisRecruiting
  • Cancer Care Specialists of Illinois - DecaturDecatur, IllinoisRecruiting
  • Carilion Roanoke Memorial HospitalRoanoke, VirginiaRecruiting
  • Carle at The RiverfrontDanville, IllinoisRecruiting
  • Carle Cancer CenterUrbana, IllinoisRecruiting
  • Carle Physician Group-EffinghamEffingham, IllinoisRecruiting
  • Carle Physician Group-Mattoon/CharlestonMattoon, IllinoisRecruiting
  • CarolinaEast Medical CenterNew Bern, North CarolinaRecruiting
  • Community Medical CenterScranton, PennsylvaniaRecruiting
  • Geisinger Cancer Center Dickson CityDickson City, PennsylvaniaRecruiting
  • Geisinger Wyoming Valley/Henry Cancer CenterWilkes-Barre, PennsylvaniaRecruiting
  • Gibbs Cancer Center-GaffneyGaffney, South CarolinaRecruiting
  • Gibbs Cancer Center-PelhamGreer, South CarolinaRecruiting
  • Gundersen Lutheran Medical CenterLa Crosse, WisconsinRecruiting
  • Helen F Graham Cancer CenterNewark, DelawareRecruiting
  • Louisiana State University Health Science CenterNew Orleans, LouisianaRecruiting
  • Medical Oncology Hematology Consultants PANewark, DelawareRecruiting
  • Mercy HospitalCoon Rapids, MinnesotaRecruiting
  • Mercy Hospital Saint LouisSt Louis, MissouriRecruiting
  • Minnesota Oncology Hematology PA-MaplewoodMaplewood, MinnesotaRecruiting
  • Nash UNC HealthCareRocky Mount, North CarolinaRecruiting
  • Ochsner Medical Center JeffersonNew Orleans, LouisianaRecruiting
  • OptumCare Cancer Care at CharlestonLas Vegas, NevadaRecruiting
  • Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, MinnesotaRecruiting
  • Regional Cancer Center at Johnson City Medical CenterJohnson City, TennesseeRecruiting
  • Regions HospitalSaint Paul, MinnesotaRecruiting
  • Ridgeview Medical CenterWaconia, MinnesotaRecruiting
  • Saint Francis Cancer CenterGreenville, South CarolinaRecruiting
  • Saint Francis HospitalGreenville, South CarolinaRecruiting
  • Saint John's Hospital - HealtheastMaplewood, MinnesotaRecruiting
  • Saint Vincent Hospital Cancer Center at Saint Mary'sGreen Bay, WisconsinRecruiting
  • Saint Vincent Hospital Cancer Center at Sturgeon BaySturgeon Bay, WisconsinRecruiting
  • Saint Vincent Hospital Cancer Center Green BayGreen Bay, WisconsinRecruiting
  • SMC Center for Hematology Oncology UnionUnion, South CarolinaRecruiting
  • Spartanburg Medical CenterSpartanburg, South CarolinaRecruiting
  • University Medical Center New OrleansNew Orleans, LouisianaRecruiting
  • University of Kansas Cancer CenterKansas City, KansasRecruiting
  • University of Kansas Cancer Center - Lee's SummitLee's Summit, MissouriRecruiting
  • University of Kansas Cancer Center - NorthKansas City, MissouriRecruiting
  • University of Kansas Cancer Center-Overland ParkOverland Park, KansasRecruiting
  • University of Kansas Health System Saint Francis CampusTopeka, KansasRecruiting
  • University of Kansas Hospital-Westwood Cancer CenterWestwood, KansasRecruiting
  • VCU Massey Cancer Center at Stony PointRichmond, VirginiaRecruiting
  • VCU Massey Comprehensive Cancer CenterRichmond, VirginiaRecruiting
Who to ask about joining
Who can join

Men aged 50 and older diagnosed with Stage I-IV prostate cancer without bone spread can join. Participants should be starting or have recently begun hormone therapy for prostate cancer. They must have certain vitamin and calcium levels and agree not to take other supplements during the study. The trial team will confirm eligibility.

What happens during the trial

Participants will be placed into one of two groups by chance. One group will take high-dose vitamin D once a week for a year. The other group will take a placebo, which looks like the vitamin but has no active ingredient, also once a week for a year. All participants will have blood tests and scans to measure bone health throughout the study.

The trial team

The trial is run by the University of Rochester, with Dr. Luke J Peppone as the principal investigator. The National Cancer Institute is collaborating with them.

Important dates

The trial started on December 14, 2023, and is expected to finish by April 29, 2029. It is currently enrolling new participants.

Additional information

This is a Phase 3 trial, which means it is looking at how well the treatment works and its safety. The trial hopes to include about 240 participants. It is not regulated by the FDA for drugs or devices.

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