Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance

NCT00482157 | Withdrawn

• 2 other identifiers: PROS002297408
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

After the diagnosis of prostate cancer, many men alter their lifestyle or diet or use various supplements in an attempt to retard the growth of their cancer. While there is limited data on the use of diet and supplements to alter the risk of prostate cancer, even less is known regarding the ability of diet or supplements to alter progression. For men who have elected active surveillance, the investigators propose to investigate the ability of vitamin D to retard the growth of prostate cancer.

Conditions

Prostatic Neoplasms; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• changes in expression of biomarkers as assessed by prostate biopsy

  6 months

Interventions

Vitamin D (Calcitriol) DRUG

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PSA \<10.0 ng/ml
• Gleason sum 6 or \<2 mm Gleason pattern 4

You may not qualify if:

• Use of Finasteride, Dutasteride, Saw Palmetto
• Use of NSAIDs, COX-2 inhibitors and/or aspirin, soy or vitamin D supplements for more than 7 days over the one month prior to study
• Kidney disease, hypercalcemia or renal stones
• ECOG performance status \>1
• Uncontrolled hypertension, unstable angina, history of transient ischemic attack (TIA), history of stroke.

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Vitamin D; Calcitriol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Joseph C. Presti Jr.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2007
• First Posted: June 4, 2007
• Study Start: February 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: March 3, 2022

Record last verified: 2022-02