Trial Outcomes & Findings for Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation (NCT NCT00887432)

Last Updated: 2021-10-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

132 participants

Primary outcome timeframe

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

Results posted on

2021-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	58	74
Overall Study COMPLETED	43	60
Overall Study NOT COMPLETED	15	14

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Start Excluded Therapy	3	0
Overall Study Did not complete treatment	6	8
Overall Study Protocol Violation	2	3
Overall Study Withdrawal by Subject	3	2
Overall Study Lost to Follow-up	1	0
Overall Study No reason provided	0	1

Baseline Characteristics

Lab values were not recorded for all patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Cholecalciferol and Placebo) n=58 Participants 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	Arm II (Placebo and Cholecalciferol) n=74 Participants 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	Total n=132 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=58 Participants	0 Participants n=74 Participants	0 Participants n=132 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=58 Participants	35 Participants n=74 Participants	68 Participants n=132 Participants
Age, Categorical >=65 years	25 Participants n=58 Participants	39 Participants n=74 Participants	64 Participants n=132 Participants
Age, Continuous	63.5 years STANDARD_DEVIATION 7.0 • n=58 Participants	64.9 years STANDARD_DEVIATION 6.5 • n=74 Participants	64.3 years STANDARD_DEVIATION 6.8 • n=132 Participants
Sex: Female, Male Female	0 Participants n=58 Participants	0 Participants n=74 Participants	0 Participants n=132 Participants
Sex: Female, Male Male	58 Participants n=58 Participants	74 Participants n=74 Participants	132 Participants n=132 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=58 Participants	0 Participants n=74 Participants	0 Participants n=132 Participants
Race (NIH/OMB) Asian	1 Participants n=58 Participants	0 Participants n=74 Participants	1 Participants n=132 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=58 Participants	0 Participants n=74 Participants	0 Participants n=132 Participants
Race (NIH/OMB) Black or African American	5 Participants n=58 Participants	5 Participants n=74 Participants	10 Participants n=132 Participants
Race (NIH/OMB) White	50 Participants n=58 Participants	69 Participants n=74 Participants	119 Participants n=132 Participants
Race (NIH/OMB) More than one race	0 Participants n=58 Participants	0 Participants n=74 Participants	0 Participants n=132 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=58 Participants	0 Participants n=74 Participants	2 Participants n=132 Participants
Region of Enrollment United States	58 Participants n=58 Participants	74 Participants n=74 Participants	132 Participants n=132 Participants
Serum 25(OH)D3	25.1 ng/mL STANDARD_DEVIATION 10.7 • n=18 Participants • Lab values were not recorded for all patients.	30.4 ng/mL STANDARD_DEVIATION 9.0 • n=21 Participants • Lab values were not recorded for all patients.	27.9 ng/mL STANDARD_DEVIATION 10.0 • n=39 Participants • Lab values were not recorded for all patients.
Prostate Specific Antigen (PSA)	5.2 ng/mL STANDARD_DEVIATION 2.9 • n=57 Participants • The PSA at enrollment was not available for all subejcts.	4.8 ng/mL STANDARD_DEVIATION 2.6 • n=72 Participants • The PSA at enrollment was not available for all subejcts.	5.0 ng/mL STANDARD_DEVIATION 2.7 • n=129 Participants • The PSA at enrollment was not available for all subejcts.

PRIMARY outcome

Timeframe: 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

Population: Patients who completed both periods.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=87 Participants 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	Placebo n=87 Participants 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
PSA Response	0.55 ng/mL Standard Deviation 2.13	0.31 ng/mL Standard Deviation 1.86

SECONDARY outcome

Timeframe: 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

Population: Including evaluable patients, those patients with data available under both the vitamin D and placebo conditions.

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.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=119 Participants 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	Placebo n=120 Participants 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
Slope of PSA Concentration Over Time	0.000434 (ng/mL) / day Standard Error 0.000089	0.000245 (ng/mL) / day Standard Error 0.000090

SECONDARY outcome

Timeframe: Up to 30 days after completion of study treatment (up to 22 months from start of study).

Population: All patients receiving any treatment

Summarizing the maximum observed treatment related adverse event. Summarize by arm and grade using frequencies and relative frequencies..

Outcome measures

Outcome measures
Measure	Cholecalciferol n=119 Participants 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	Placebo n=120 Participants 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
Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 Grade 5	0 Participants	0 Participants
Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 No AE	117 Participants	118 Participants
Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 Grade 1	1 Participants	2 Participants
Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 Grade 2	0 Participants	0 Participants
Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 Grade 3	1 Participants	0 Participants
Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 Grade 4	0 Participants	0 Participants

Adverse Events

Cholecalciferol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cholecalciferol n=119 participants at risk 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	Placebo n=120 participants at risk 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
Metabolism and nutrition disorders Hypophosphataemia	0.84% 1/119 • Number of events 1 • Within 30 days of treatment completion (up to 22 months from start of study).	0.00% 0/120 • Within 30 days of treatment completion (up to 22 months from start of study).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/119 • Within 30 days of treatment completion (up to 22 months from start of study).	1.7% 2/120 • Number of events 2 • Within 30 days of treatment completion (up to 22 months from start of study).
Renal and urinary disorders Nephrolithiasis	0.84% 1/119 • Number of events 1 • Within 30 days of treatment completion (up to 22 months from start of study).	0.00% 0/120 • Within 30 days of treatment completion (up to 22 months from start of study).

Additional Information

Kris Attwood

Roswell Park Comprehensive Cancer Center

Phone: 716-845-1300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place