Clinical trial NCT05838716: High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
Official title: High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
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
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-01
Enrollment: 366
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVES:

I. 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:

I. 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 OBJECTIVES:

I. To explore the effect of HDVD supplementation on bone biomarkers measured by Millipore Luminex/enzyme-linked immunosorbent assay (ELISA) assays from serum.

II. 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.

Eligibility criteria: Inclusion Criteria:

* 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 60 years or older
* Be starting ADT or have received their first ADT treatment in the past 3 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 27 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Reduction of bone mineral density (BMD) loss as measured at the total hip
timeFrame: At 52 weeks
measure: Reduction of BMD loss as measured at the femoral neck
timeFrame: At 52 weeks
measure: Reduction of BMD loss as measured at the distal radius
timeFrame: At 52 weeks
measure: Reduction of BMD loss as measured at the lumbar spine
timeFrame: At 52 weeks
Secondary outcomes:
measure: Change in falls
timeFrame: Baseline up to 52 weeks
measure: Change in fractures
timeFrame: Baseline up to 52 weeks
measure: Change in quality of life
timeFrame: Baseline up to 52 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Helen F Graham Cancer Center
state: Delaware
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants PA
state: Delaware
city: Danville
country: United States
facility: Carle at The Riverfront
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Illinois - Decatur
state: Illinois
city: Effingham
country: United States
facility: Carle Physician Group-Effingham
state: Illinois
city: Mattoon
country: United States
facility: Carle Physician Group-Mattoon/Charleston
state: Illinois
city: O'Fallon
country: United States
facility: Cancer Care Center of O'Fallon
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Overland Park
country: United States
facility: University of Kansas Cancer Center-Overland Park
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Hospital-Westwood Cancer Center
state: Kansas
city: New Orleans
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center Jefferson
state: Louisiana
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology PA-Maplewood
state: Minnesota
city: Maplewood
country: United States
facility: Saint John's Hospital - Healtheast
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic - Saint Louis Park
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Kansas City
country: United States
facility: University of Kansas Cancer Center - North
state: Missouri
city: Lee's Summit
country: United States
facility: University of Kansas Cancer Center - Lee's Summit
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis
state: Missouri
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at Charleston
state: Nevada
city: New Bern
country: United States
facility: CarolinaEast Medical Center
state: North Carolina
city: Rocky Mount
country: United States
facility: Nash UNC HealthCare
state: North Carolina
city: Scranton
country: United States
facility: Community Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley/Henry Cancer Center
state: Pennsylvania
city: Gaffney
country: United States
facility: Gibbs Cancer Center-Gaffney
state: South Carolina
city: Greenville
country: United States
facility: Saint Francis Hospital
state: South Carolina
city: Greenville
country: United States
facility: Saint Francis Cancer Center
state: South Carolina
city: Greer
country: United States
facility: Gibbs Cancer Center-Pelham
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Union
country: United States
facility: SMC Center for Hematology Oncology Union
state: South Carolina
city: Johnson City
country: United States
facility: Regional Cancer Center at Johnson City Medical Center
state: Tennessee
city: Kingsport
country: United States
facility: Ballad Health Cancer Care - Kingsport
state: Tennessee
city: Bristol
country: United States
facility: Ballad Health Cancer Care - Bristol
state: Virginia
city: Mechanicsville
country: United States
facility: Bon Secours Memorial Regional Medical Center
state: Virginia
city: Midlothian
country: United States
facility: Bon Secours Saint Francis Medical Center
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Saint Mary's Hospital
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Cancer Institute at Reynolds Crossing
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Cancer Center at Stony Point
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center at Saint Mary's
state: Wisconsin
city: Sturgeon Bay
country: United States
facility: Saint Vincent Hospital Cancer Center at Sturgeon Bay
state: Wisconsin
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Luke J Peppone, PhD
role: PRINCIPAL_INVESTIGATOR
References: