Vitamin D for Prostate Endocrine Therapy

NCT05838716 | Recruiting Phase 3 DMC

• 4 other identifiers: URCC-22053NCI-2022-07664R01CA258349UG1CA189961
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 51

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.

Conditions

Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (4)

• Reduction of bone mineral density (BMD) loss as measured at the total hip

  Will determine the efficacy of high-dose vitamin D (HDVD) supplementation versus placebo in reducing BMD loss as measured at the total hip via dual-energy x-ray absorptiometry (DXA) at 52 weeks. Will use analysis of covariance (ANCOVA) with group (vitamin D or placebo) as the main factor, baseline timepoint (\[T\]1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial linear mixed model (LMM) will be fit using Restricted Maximum Likelihood (REML) estimation. The significance of the variance due to study site will be tested using the Wald Test.

  At 52 weeks

• Reduction of BMD loss as measured at the femoral neck

  Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the femoral neck via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial LMM will be fit using REML estimation. The significance of the variance due to study site will be tested using the Wald Test.

  At 52 weeks

• Reduction of BMD loss as measured at the distal radius

  Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the distal radius via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial LMM will be fit using REML estimation. The significance of the variance due to study site will be tested using the Wald Test.

  At 52 weeks

• Reduction of BMD loss as measured at the lumbar spine

  Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the lumbar spine via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial LMM will be fit using REML estimation. The significance of the variance due to study site will be tested using the Wald Test.

  At 52 weeks

Secondary Outcomes (3)

• Change in falls

  Baseline up to 52 weeks

• Change in fractures

  Baseline up to 52 weeks

• Change in quality of life

  Baseline up to 52 weeks

Study Arms (2)

Arm I (HDVD)

EXPERIMENTAL

Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.

Procedure: Biospecimen Collection; Dietary Supplement: D Vitamin; Procedure: Dual X-ray Absorptiometry; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.

Procedure: Biospecimen Collection; Procedure: Dual X-ray Absorptiometry; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (HDVD); Arm II (placebo)

D Vitamin DIETARY_SUPPLEMENT

Given PO

Also known as: 3-[2-[7a-methyl-1-(1,4,5-trimethylhex-2-enyl)-1,2,3,3a,5,6,7,7a-octahydroinden-4-ylidene]ethylidene]-4-methylidene-cyclohexan-1-ol, Vitamin D, Vitamin D Compound, Vitamin-D

Arm I (HDVD)

Dual X-ray Absorptiometry PROCEDURE

Undergo DXA scan

Also known as: BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density), DEXA Scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN

Arm I (HDVD); Arm II (placebo)

Placebo Administration DRUG

Given PO

Arm II (placebo)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (HDVD); Arm II (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (HDVD); Arm II (placebo)

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (51)

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

RECRUITING

Carle at The Riverfront

Danville, Illinois, 61832, United States

RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

RECRUITING

Carle Cancer Center

Urbana, Illinois, 61801, United States

RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

RECRUITING

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States

RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Louisiana State University Health Science Center

New Orleans, Louisiana, 70112, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

RECRUITING

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

RECRUITING

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

RECRUITING

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

RECRUITING

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102, United States

RECRUITING

CarolinaEast Medical Center

New Bern, North Carolina, 28561, United States

RECRUITING

Nash UNC HealthCare

Rocky Mount, North Carolina, 27804, United States

RECRUITING

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

RECRUITING

Geisinger Cancer Center Dickson City

Dickson City, Pennsylvania, 18519, United States

RECRUITING

Community Medical Center

Scranton, Pennsylvania, 18510, United States

RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

RECRUITING

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, 29341, United States

RECRUITING

Saint Francis Hospital

Greenville, South Carolina, 29601, United States

RECRUITING

Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

RECRUITING

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

RECRUITING

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

RECRUITING

SMC Center for Hematology Oncology Union

Union, South Carolina, 29379, United States

RECRUITING

Regional Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, 37604, United States

RECRUITING

Ballad Health Cancer Care - Kingsport

Kingsport, Tennessee, 37660, United States

RECRUITING

Ballad Health Cancer Care - Bristol

Bristol, Virginia, 24201, United States

RECRUITING

Bon Secours Memorial Regional Medical Center

Mechanicsville, Virginia, 23116, United States

RECRUITING

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, 23114, United States

RECRUITING

Bon Secours Saint Mary's Hospital

Richmond, Virginia, 23226, United States

RECRUITING

Bon Secours Cancer Institute at Reynolds Crossing

Richmond, Virginia, 23230, United States

RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States

RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24033, United States

RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

RECRUITING

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303, United States

RECRUITING

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

RECRUITING

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Specimen Handling; Cholecalciferol; Vitamin D; Absorptiometry, Photon; Bone Density

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Luke J Peppone

  University of Rochester NCORP Research Base

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: URCC Study Chair

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 1, 2023
• Study Start: December 14, 2023
• Primary Completion (Estimated): April 29, 2029
• Study Completion (Estimated): April 29, 2029
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (51)