Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I 95406 | Other Identifier | Roswell Park Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily. |
|
| Arm II | Experimental | Patients receive 6,000 IU of vitamin D3 once daily. |
|
| Arm III | Experimental | Patients receive 8,000 IU of vitamin D3 once daily. |
|
| Arm IV | Experimental | Patients receive 10,000 IU of vitamin D3 once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol | Dietary Supplement | Given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pattern of Response of Serum 25(OH) D3 Levels | Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test. | Baseline, at 1, 3, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern of Response of Parathormone | Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test. | Baseline, at 1, 3, 6 months |
| Toxicity |
Not provided
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Donald L. Trump, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
Total 148 patients were treated but only 128 patients were eligible for study outcome analysis.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm I: Vitamin D 4000 IU Daily | Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily. cholecalciferol: Given orally |
| FG001 | Arm II: Vitamin D 6000 IU Daily | Patients receive 6,000 IU of vitamin D3 once daily. cholecalciferol: Given orally |
| FG002 | Arm III: Vitamin D 8000 IU Daily | Patients receive 8,000 IU of vitamin D3 once daily. cholecalciferol: Given orally |
| FG003 | Arm IV: Vitamin D 10,000 IU Daily | Patients receive 10,000 IU of vitamin D3 once daily. cholecalciferol: Given orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated and eligible patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I: Vitamin D 4000 IU Daily | Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily. cholecalciferol: Given orally |
| BG001 | Arm II: Vitamin D 6000 IU Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pattern of Response of Serum 25(OH) D3 Levels | Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test. | All treated and eligible patients | Posted | Mean | Standard Deviation | ng/mL | Baseline, at 1, 3, 6 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I: Vitamin D 4000 IU Daily | Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily. cholecalciferol: Given orally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Number of treated patients that had serious adverse events.
| Baseline, at 1, 3 and 6 months |
| Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls | Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls | Baseline, at 1, 3 ,6 months |
| Adverse Event |
|
| Other |
|
| Withdrawal by Subject |
|
Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally
| BG002 | Arm III: Vitamin D 8000 IU Daily | Patients receive 8,000 IU of vitamin D3 once daily. cholecalciferol: Given orally |
| BG003 | Arm IV: Vitamin D 10,000 IU Daily | Patients receive 10,000 IU of vitamin D3 once daily. cholecalciferol: Given orally |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Arm III: Vitamin D 8000 IU Daily | Patients receive 8,000 IU of vitamin D3 once daily. cholecalciferol: Given orally |
| OG003 | Arm IV: Vitamin D 10,000 IU Daily | Patients receive 10,000 IU of vitamin D3 once daily. cholecalciferol: Given orally |
|
|
|
| Secondary | Pattern of Response of Parathormone | Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test. | All treated and eligible patients | Posted | Mean | Standard Deviation | pg/mL | Baseline, at 1, 3, 6 months |
|
|
|
|
| Secondary | Toxicity | Number of treated patients that had serious adverse events. | All treated and eligible patients | Posted | Number | participants | Baseline, at 1, 3 and 6 months |
|
|
|
| Secondary | Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls | Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls | All treated and eligible patients | Posted | Number | participants | Baseline, at 1, 3 ,6 months |
|
|
|
| 2 |
| 37 |
| 3 |
| 37 |
| EG001 | Arm II: Vitamin D 6000 IU Daily | Patients receive 6,000 IU of vitamin D3 once daily. cholecalciferol: Given orally | 0 | 35 | 3 | 35 |
| EG002 | Arm III: Vitamin D 8000 IU Daily | Patients receive 8,000 IU of vitamin D3 once daily. cholecalciferol: Given orally | 1 | 36 | 3 | 36 |
| EG003 | Arm IV: Vitamin D 10,000 IU Daily | Patients receive 10,000 IU of vitamin D3 once daily. cholecalciferol: Given orally | 5 | 40 | 9 | 40 |
| Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Investigation | Investigations | Systematic Assessment |
|
| Monarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | Systematic Assessment |
|
| Radical prostatectomy | Surgical and medical procedures | Systematic Assessment |
|
| Spinal laminectomy | Surgical and medical procedures | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Thirst | General disorders | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Oral fungal infection | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood 1,25-dihydroxycholecalciferol increased | Investigations | Systematic Assessment |
|
| Blood albumin decreased | Investigations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Blood glucose increased | Investigations | Systematic Assessment |
|
| Haemoglobin increased | Investigations | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Internal fixation of fracture | Surgical and medical procedures | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| 3-month |
|
| 6-month |
|
| t-test, 2 sided |
| 0.1025 |
| 2-Sided |
| No |
| Superiority or Other |
| Change from Baseline in PTH Levels at 6-Month for dose level 4000 IU. | t-test, 2 sided | 0.1744 | 2-Sided | No | Superiority or Other |
| Change from Baseline in PTH Levels at 1-month for 6000 IU. Statistical analysis was done using one sample t-test. | t-test, 2 sided | 0.1281 | 2-Sided | No | Superiority or Other |
| Change from Baseline in PTH Levels at 3-month for 6000 IU. Statistical analysis was done using one sample t-test. | t-test, 2 sided | 0.9688 | 2-Sided | No | Superiority or Other |
| Change from Baseline in PTH Levels at 6-month for 6000 IU. Statistical analysis was done using one sample t-test. | t-test, 2 sided | <0.0001 | 2-Sided | No | Superiority or Other |
| Change from Baseline in PTH Levels at 1-month for 8000 IU. Statistical analysis was done using one sample t-test. | t-test, 2 sided | 0.8241 | 2-Sided | No | Superiority or Other |
| Change from Baseline in PTH Levels at 3-month for 8000 IU. Statistical analysis was done using one sample t-test. | t-test, 2 sided | 0.1828 | 2-Sided | No | Superiority or Other |
| Change from Baseline in PTH Levels at 6-month for 8000 IU. Statistical analysis was done using one sample t-test. | t-test, 2 sided | 0.1348 | 2-Sided | No | Superiority or Other |
| Change from Baseline in PTH Levels at 1-month for 10000 IU. Statistical analysis was done using one sample t-test. | t-test, 2 sided | 0.2214 | 2-Sided | No | Superiority or Other |
| Change from Baseline in PTH Levels at 3-month for 10000 IU. Statistical analysis was done using one sample t-test. | t-test, 2 sided | 0.0079 | 2-Sided | No | Superiority or Other |
| Change from Baseline in PTH Levels at 6-month for 10000 IU. Statistical analysis was done using one sample t-test. | t-test, 2 sided | 0.0631 | 2-Sided | No | Superiority or Other |