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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01530 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 128308 | Other Identifier | Roswell Park Cancer Institute | |
| P30CA016056 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized clinical trial studies how well cholecalciferol supplement works in treating patients with localized prostate cancer undergoing observation. Cholecalciferol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly.
PRIMARY OBJECTIVES:
I. To determine the prostate-specific antigen (PSA) response with oral high dose vitamin D3 supplementation (cholecalciferol) in patients with localized, histologically proven adenocarcinoma of the prostate who have not received any treatment for prostate cancer ever and have chosen expectant management.
SECONDARY OBJECTIVES:
I. To examine the pattern of response of PSA dynamics as well as the absolute change in PSA following vitamin D3 supplementation.
II. Assess the toxicity of vitamin D3 supplementation in men with prostate cancer.
TERTIARY OBJECTIVES:
I. Track occurrence of infections, deep venous thrombosis, vascular events and falls in the study population.
II. To evaluate relationship between cytochrome P450 family 24 (CYP24), 27B1, single-nucleotide polymorphism (SNPs) and serum 25(hydroxy [OH]) vitamin D response to oral D3 supplementation.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cholecalciferol orally (PO) once daily (QD) for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.
ARM II: Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.
After completion of study treatment, patients are followed up for 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (cholecalciferol and placebo) | Experimental | Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II. |
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| Arm II (placebo and cholecalciferol) | Experimental | Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Dietary Supplement | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| PSA Response | Difference in the mean change in PSA on vitamin D (9 month period: pre-Vitamin D to 9 months after start of vitamin D) versus on placebo (9 month period: pre-Placebo to 9 months after starting placebo). Compared using a paired t-test. | 9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Slope of PSA Concentration Over Time | The PSA levels were modeled as a function of treatment, time, their interaction, sequence, and a random subject effect using a linear mixed model. From this model, the subject specific PSA slope was obtained for each subject under each condition (vitamin D versus placebo). The PSA slopes were then compared between treatment conditions using linear mixed model to account for treatment arm and repeated measures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Mohler | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cholecalciferol to Placebo | Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to placebo PO QD for 9 months. Cholecalciferol: Given PO Laboratory Biomarker Analysis: Correlative studies Patient Observation Placebo Administration: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2018 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Patient Observation | Other |
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| Placebo Administration | Drug | Given PO |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| 9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment -Up to 30 days after completion of study treatment |
| Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | Summarizing the maximum observed treatment related adverse event. Summarize by arm and grade using frequencies and relative frequencies.. | Up to 30 days after completion of study treatment (up to 22 months from start of study). |
| FG001 | Placebo to Cholecalciferol | Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Cholecalciferol PO QD for 9 months. Cholecalciferol: Given PO Laboratory Biomarker Analysis: Correlative studies Patient Observation Placebo Administration: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Cholecalciferol and Placebo) | Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to placebo PO QD for 9 months. Cholecalciferol: Given PO Laboratory Biomarker Analysis: Correlative studies Patient Observation Placebo Administration: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG001 | Arm II (Placebo and Cholecalciferol) | Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to cholecalciferol PO QD for 9 months. Cholecalciferol: Given PO Laboratory Biomarker Analysis: Correlative studies Patient Observation Placebo Administration: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Serum 25(OH)D3 | Baseline vitamin D measured in serum blood samples. | Lab values were not recorded for all patients. | Mean | Standard Deviation | ng/mL |
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| Prostate Specific Antigen (PSA) | The PSA at enrollment was not available for all subejcts. | Mean | Standard Deviation | ng/mL |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | PSA Response | Difference in the mean change in PSA on vitamin D (9 month period: pre-Vitamin D to 9 months after start of vitamin D) versus on placebo (9 month period: pre-Placebo to 9 months after starting placebo). Compared using a paired t-test. | Patients who completed both periods. | Posted | Mean | Standard Deviation | ng/mL | 9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment |
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| Secondary | Slope of PSA Concentration Over Time | The PSA levels were modeled as a function of treatment, time, their interaction, sequence, and a random subject effect using a linear mixed model. From this model, the subject specific PSA slope was obtained for each subject under each condition (vitamin D versus placebo). The PSA slopes were then compared between treatment conditions using linear mixed model to account for treatment arm and repeated measures. | Including evaluable patients, those patients with data available under both the vitamin D and placebo conditions. | Posted | Least Squares Mean | Standard Error | (ng/mL) / day | 9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment -Up to 30 days after completion of study treatment |
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| Secondary | Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | Summarizing the maximum observed treatment related adverse event. Summarize by arm and grade using frequencies and relative frequencies.. | All patients receiving any treatment | Posted | Count of Participants | Participants | Up to 30 days after completion of study treatment (up to 22 months from start of study). |
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Within 30 days of treatment completion (up to 22 months from start of study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Cholecalciferol | Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. Cholecalciferol: Given PO Laboratory Biomarker Analysis: Correlative studies Patient Observation Placebo Administration: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 119 | 0 | 119 | 2 | 119 |
| EG001 | Placebo | Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. Cholecalciferol: Given PO Laboratory Biomarker Analysis: Correlative studies Patient Observation Placebo Administration: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 120 | 0 | 120 | 2 | 120 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kris Attwood | Roswell Park Comprehensive Cancer Center | 716-845-1300 | Kris.Attwood@roswellpark.org |
| May 4, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D057832 | Watchful Waiting |
| D019370 | Observation |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Between 18 and 65 years |
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| >=65 years |
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