Stage I Prostate Cancer AJCC v8Phase 3ViPERNCT05838716
Vitamin D for Prostate Endocrine Therapy
A Phase 3 study testing Biospecimen Collection, D Vitamin and Dual X-ray Absorptiometry in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by University of Rochester at 51 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, D Vitamin and Dual X-ray Absorptiometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 51 sitesUnited States
- Study dates
- 14 Dec 2023to 29 Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
51 sites in 1 country. Contact the study team or a site near you to ask about taking part.
51 sites in 1 country
United States51 sites, 51 recruiting
- Recruiting
Ballad Health Cancer Care - Bristol
Bristol, Virginia, 24201
Site Public Contact, 423-431-5654, charles.mays@balladhealth.org
Asheesh Shipstone
- Recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Site Public Contact, 877-779-7585, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Vamsi K. Vasireddy
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
Site Public Contact, 877-204-6081, hemoncctrials@geisinger.edu
Heath B. Mackley
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Brian L. Burnette
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Brian L. Burnette
- Recruiting
Saint Francis Hospital
Greenville, South Carolina, 29601
Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org
Stephen H. Dyar
- Recruiting
Saint Francis Cancer Center
Greenville, South Carolina, 29607
Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org
Stephen H. Dyar
- Recruiting
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Regional Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, 37604
Site Public Contact, 423-431-5654, charles.mays@balladhealth.org
Asheesh Shipstone
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Elizabeth M. Wulff
- Recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Elizabeth M. Wulff
- Recruiting
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660
Site Public Contact, 423-431-5654, charles.mays@balladhealth.org
Asheesh Shipstone
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
Kurt Oettel
- Recruiting
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Elizabeth M. Wulff
- Recruiting
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
William J. Irvin
- Recruiting
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
William J. Irvin
- Recruiting
CarolinaEast Medical Center
New Bern, North Carolina, 28561
Site Public Contact, 252-634-6589, lharrison@carolinaeasthealth.com
Seth M. Miller
- Recruiting
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Rajasree P. Chowdry
- Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Rajasree P. Chowdry
- Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org
Brian T. Halbert
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Elizabeth M. Wulff
- Recruiting
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
William J. Irvin
- Recruiting
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230
Site Public Contact, 804-893-8978, Anne_caramella@bshsi.org
William J. Irvin
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Site Public Contact, ctoclinops@vcu.edu
Asit K. Paul
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Asit K. Paul
- Recruiting
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033
Site Public Contact, 540-981-7377
Asit K. Paul
- Recruiting
Nash UNC HealthCare
Rocky Mount, North Carolina, 27804
Site Public Contact, 252-952-8000
Elie B. Choufani
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Community Medical Center
Scranton, Pennsylvania, 18510
Site Public Contact, 570-703-4768, HemonCCTrials@geisinger.edu
Heath B. Mackley
- Recruiting
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Site Public Contact, 314-251-7066
Jay W. Carlson
- Recruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Brian L. Burnette
- Recruiting
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
Site Public Contact, 785-295-8000, KUCC_Navigation@kumc.edu
Elizabeth M. Wulff
- Recruiting
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
Ridgeview Medical Center
Waconia, Minnesota, 55387
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Elizabeth M. Wulff
- Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Heath B. Mackley
About this study
Official title: High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the effect of high-dose vitamin D (HDVD) supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the total hip over 52 weeks as measured by dual-energy x-ray absorptiometry (DXA).
II. To evaluate the effect of HDVD supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the femoral neck, distal radius, and lumbar spine (L1-L4) over 52 weeks as measured by DXA.
SECONDARY OBJECTIVES:
- To evaluate the effect of HDVD supplementation on falls over 52 weeks as measured by the Falls History questionnaire.
II. To evaluate the effect of HDVD supplementation on fractures over 52 weeks as determined by the Clinical Record Information - Follow-up Form.
III. To evaluate the effect of HDVD supplementation on quality of life over 52 weeks as measured by the Functional Assessment of Cancer Therapy- Prostate (FACT-P).
EXPLORATORY OBJECTIVE:
- To evaluate the effect of HDVD supplementation on pain, fatigue, sleep, and activities of daily living over 52 weeks as measured by patient-reported outcomes.
OUTLINE: After undergoing collection of blood and DXA scan, patients are randomized to 1 of 2 arms.
ARM I: Patients receive HDVD orally (PO) once a week (QW) for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
ARM II: Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
- 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
- Being tested
- Biospecimen Collection, D Vitamin, Dual X-ray Absorptiometry, Placebo Administration, Quality-of-Life Assessment
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood
D VitaminDietary supplement
Also called 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
Given PO
Dual X-ray AbsorptiometryProcedure or surgery
Also called BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density)
Undergo DXA scan
Placebo AdministrationDrug
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (HDVD) | Experimental | Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study. Receives: 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. Receives: Procedure: Biospecimen Collection; Procedure: Dual X-ray Absorptiometry; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 52 weeks
Secondary outcomes (3)
Change in falls
Will use generalized linear mixed models. Logistic regression models will be used to estimate the between group difference in (1) the proportion of participants who experience a fall/fracture (YES/NO) from T1 to T3. Will evaluate the distribution of total number of falls/fractures by Poisson models analysis to estimate the between group difference in (2) the total number of falls/fractures from T1 to T3. Both models (1, 2) will contain group as fixed effect and site as a random effect. Additional adjustment covariates will include falls in the previous 6 months, fractures in the previous 5 years, androgen-deprivation therapy (ADT) dose and duration, stage, radiation therapy, prior surgery, baseline vitamin D, age, body mass index (BMI), and race. Nonsignificant (P > 0.05) covariates will be removed from the model. Will report the estimates and associated 95% confidence intervals as (1) relative risk or (2) rate ratio.
Measured: Baseline up to 52 weeks
Change in fractures
Will use generalized linear mixed models. Logistic regression models will be used to estimate the between group difference in (1) the proportion of participants who experience a fall/fracture (YES/NO) from T1 to T3. Will evaluate the distribution of total number of falls/fractures by Poisson models analysis to estimate the between group difference in (2) the total number of falls/fractures from T1 to T3. Both models (1, 2) will contain group as fixed effect and site as a random effect. Additional adjustment covariates will include falls in the previous 6 months, fractures in the previous 5 years, ADT dose and duration, stage, radiation therapy, prior surgery, baseline vitamin D, age, BMI, and race. Nonsignificant (P > 0.05) covariates will be removed from the model. Will report the estimates and associated 95% confidence intervals as (1) relative risk or (2) rate ratio.
Measured: Baseline up to 52 weeks
Change in quality of life
Will be evaluated by Functional Assessment of Cancer Therapy-Prostate Trial Outcome Index score.
Measured: Baseline up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start14 Dec 2023
- Primary completion29 Apr 2029 (estimated)
- Study completion29 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Prostate Cancer AJCC v8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Luke Peppone, University of Rochester NCORP Research Base
- Investigators
- Luke J Peppone, Principal investigator, University of Rochester NCORP Research Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838716
- Sponsor's protocol ID
- URCC-22053
- Other IDs
- NCI-2022-07664, URCC-22053, URCC-22053, URCC-22053, R01CA258349, UG1CA189961
- Acronym
- ViPER
- Status last verified
- Jan 2026
- First submitted
- 20 Apr 2023
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT05838716
- Acronym / sponsor ID
- ViPER / URCC-22053
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 29 Apr 2029 (estimated)
- Study completion
- 29 Apr 2029 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the effect of high-dose vitamin D (HDVD) supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the total hip over 52 weeks as measured by dual-energy x-ray absorptiometry (DXA).
II. To evaluate the effect of HDVD supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the femoral neck, distal radius, and lumbar spine (L1-L4) over 52 weeks as measured by DXA.
SECONDARY OBJECTIVES:
- To evaluate the effect of HDVD supplementation on falls over 52 weeks as measured by the Falls History questionnaire.
II. To evaluate the effect of HDVD supplementation on fractures over 52 weeks as determined by the Clinical Record Information - Follow-up Form.
III. To evaluate the effect of HDVD supplementation on quality of life over 52 weeks as measured by the Functional Assessment of Cancer Therapy- Prostate (FACT-P).
EXPLORATORY OBJECTIVE:
- To evaluate the effect of HDVD supplementation on pain, fatigue, sleep, and activities of daily living over 52 weeks as measured by patient-reported outcomes.
OUTLINE: After undergoing collection of blood and DXA scan, patients are randomized to 1 of 2 arms.
ARM I: Patients receive HDVD orally (PO) once a week (QW) for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
ARM II: Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (HDVD) | Experimental | Procedure: Biospecimen Collection, Dietary Supplement: D Vitamin, Procedure: Dual X-ray Absorptiometry, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study. |
| Arm II (placebo) | Placebo comparator | Procedure: Biospecimen Collection, Procedure: Dual X-ray Absorptiometry, Drug: Placebo Administration, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood | Procedure or surgery | Arm I (HDVD), Arm II (placebo) |
| D VitaminAlso: 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-DGiven PO | Dietary supplement | Arm I (HDVD) |
| Dual X-ray AbsorptiometryAlso: BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density)Undergo DXA scan | Procedure or surgery | Arm I (HDVD), Arm II (placebo) |
| Placebo AdministrationGiven PO | Drug | Arm II (placebo) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (HDVD), Arm II (placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (HDVD), Arm II (placebo) |
Primary outcome
Reduction of bone mineral density (BMD) loss as measured at the total hip
Time frame: At 52 weeks
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.
Reduction of BMD loss as measured at the femoral neck
Time frame: At 52 weeks
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.
Reduction of BMD loss as measured at the distal radius
Time frame: At 52 weeks
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.
Reduction of BMD loss as measured at the lumbar spine
Time frame: At 52 weeks
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.
3 secondary outcomes
Change in falls
Time frame: Baseline up to 52 weeks
Change in fractures
Time frame: Baseline up to 52 weeks
Change in quality of life
Time frame: Baseline up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Oncology Hematology Consultants PA
Newark, United States
Luke J Peppone principal investigator
University of Rochester NCORP Research Base
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biospecimen Collection, D Vitamin and Dual X-ray Absorptiometry in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by University of Rochester at 51 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of bone mineral density (BMD) loss as measured at the total hip (time frame: At 52 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.