Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation

NCT00887432 | Completed Results DMC

• 3 other identifiers: I 128308NCI-2009-01530P30CA016056
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Slope of PSA Concentration Over Time

  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

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

Study Arms (2)

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.

Dietary Supplement: Cholecalciferol; Other: Laboratory Biomarker Analysis; Other: Patient Observation; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

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.

Dietary Supplement: Cholecalciferol; Other: Laboratory Biomarker Analysis; Other: Patient Observation; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

Given PO

Also known as: 9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3

Arm I (cholecalciferol and placebo); Arm II (placebo and cholecalciferol)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (cholecalciferol and placebo); Arm II (placebo and cholecalciferol)

Patient Observation OTHER

Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting

Arm I (cholecalciferol and placebo); Arm II (placebo and cholecalciferol)

Placebo Administration DRUG

Given PO

Arm I (cholecalciferol and placebo); Arm II (placebo and cholecalciferol)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (cholecalciferol and placebo); Arm II (placebo and cholecalciferol)

Questionnaire Administration OTHER

Ancillary studies

Arm I (cholecalciferol and placebo); Arm II (placebo and cholecalciferol)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient with clinically localized, histologically proven adenocarcinoma of prostate who has not received any treatment for prostate cancer ever and has chosen active surveillance; treatment for prostate cancer is defined as prostatectomy, androgen deprivation, brachytherapy or a full course of external beam irradiation
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Willingness to comply with study guidelines
• Willingness and ability to consent
• (OH) D3 level less than 40 ng/ml within 3 months of initiation of study; most recent 25 hydroxy D level within last 3 month would be used

You may not qualify if:

• History of malabsorption syndrome e.g., pancreatic insufficiency, celiac disease, tropical sprue
• Creatinine \> 2.0 mg/dL
• Corrected serum calcium level of \> 10.5 mg/dL (serum corrected calcium = serum calcium + 0.8\[4-serum albumin\])
• Most recent PSA value more than 18 months ago
• Prior or current therapy for prostate cancer
• Documented history of nephrolithiasis within the past 5 years
• Patients receiving finasteride (Proscar) or dutasteride (Avodart) or men who have received either agent within 90 days of entry are ineligible
• Patients cannot take any additional vitamin D supplementation during study treatment; patients taking \> 2000 IU per day prior to treatment will be ineligible

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

Cholecalciferol; Watchful Waiting; Observation

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Investigative Techniques

Results Point of Contact

• Title: Kris Attwood
• Organization: Roswell Park Comprehensive Cancer Center

Kris.Attwood@roswellpark.org

716-845-1300

Study Officials

• James Mohler

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: April 8, 2009
• Primary Completion: June 8, 2020
• Study Completion: June 8, 2020
• Last Updated: October 26, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-10

Locations

US (1)