Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer

NCT00499408 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: IRB00000371P30CA012197CCCWFU-85106CCCWFU-IRB00000371
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vitamin D and soy extract may be effective in lowering prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has not responded to previous treatment. PURPOSE: This phase II trial is studying how well giving vitamin D together with soy supplements works in treating patients with recurrent prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment

  up to one year

Secondary Outcomes (4)

• Changes in PSA Slope

  up to one year

• Changes in PSA Doubling Time

  up to one year

• Number of Adverse Events, Grades 1-5

  up to one year

• Time to Progression

  up to three years

Study Arms (1)

Soy and Vitamin D

EXPERIMENTAL

Patients will receive oral supplementation with both 2,000 IU per day of vitamin D (cholecalciferol) and soy (160 mg per day soy isoflavones). Serum PSA and plasma levels of vitamin D will be assessed monthly. Soy isoflavones levels will be assessed every three months.

Dietary Supplement: Vitamin D; Dietary Supplement: soy

Interventions

Vitamin D DIETARY_SUPPLEMENT

Patients will receive oral supplementation of 2,000 IU per day of vitamin D (cholecalciferol)

Also known as: cholecalciferol

Soy and Vitamin D

soy DIETARY_SUPPLEMENT

Patients will receive oral supplementation of soy (160 mg per day soy isoflavones).

Also known as: isoflavones

Soy and Vitamin D

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Histologically confirmed adenocarcinoma of the prostate
• Biochemical relapse following definitive therapy by ASTRO criteria (PSA with 3 consecutive rising measurements separated by at least one month) and minimum PSA ≥ 1.0 ng/mL
• PSA doubling time of ≥ 6 months, as demonstrated by 3 PSA measurements obtained ≥ 2 months apart
• No hormonal therapy in 6 months prior to enrollment
• ECOG performance status 0-2
• Life expectancy \> 3 months
• At least 2 years since prior definitive radiotherapy
• No concurrent cholecalciferol, calcium, or soy supplements
• Absolute granulocyte count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• Creatinine ≤ 2.0 mg/dL
• Total bilirubin ≤ 2.0 mg/dL
• Calcium \> 8.5 mg/dL and \< 10.5 mg/dL

You may not qualify if:

• No clinically evident brain metastases
• Concurrent cholecalciferol, calcium, or soy supplements
• Concurrent chemotherapy with nonstudy drugs
• Serious medical illness that would limit survival to \< 3 months, or psychiatric condition that would preclude giving informed consent
• Other malignancy except nonmelanoma skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for the past 5 years
• Active, uncontrolled bacterial, viral, or fungal infection
• Hemorrhagic disorder
• Evidence of metastatic disease by bone scan or CT scan
• History of hypercalcemia
• More History of exposure to other phytotherapeutics, including PC-SPES and Saw Palmetto, within the last year.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Vitamin D; Cholecalciferol; Isoflavones

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; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

only the most severe of each type of adverse event during treatment was recorded.

Results Point of Contact

• Title: K.C. Balaji, MD
• Organization: Comprehensive Cancer Center of Wake Forest University

kbalaji@wakehealth.edu

336-716-5690

Study Officials

• K.C. Balaji, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 21, 2018
• Results First Posted: February 17, 2014

Record last verified: 2018-10

Locations

US (1)