Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Biomarker/Laboratory analysis, Treatment Active Over 18 NCI CCCWFU-85106 CCCWFU-IRB00000371, CCCWFU 85106, NCT00499408

Objectives

1. Test the response of biochemically recurrent prostate cancer to a combination of cholecalciferol (i.e., vitamin D) and soy isoflavones (i.e., soy extract) after failed definitive local therapy as determined by PSA response.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the prostate
  • No evidence of metastatic disease by bone scan or CT scan



• Biochemical-only relapse after failed radical prostatectomy, brachytherapy, or external beam radiotherapy
  • Meets American Society for Therapeutic Radiology and Oncology definition of biochemical relapse as 3 consecutive rising PSA levels obtained at least 1 month apart
  • PSA doubling time of ≥ 6 months, as demonstrated by 3 PSA measurements obtained ≥ 2 months apart



• Minimum PSA ≥ 1.5 ng/mL
  • Bone scan and CT scan required for PSA ≥ 10 ng/ mL



• Testosterone ≥ 150 ng/dL



• No clinically evident brain metastases

Prior/Concurrent Therapy:

• More than 6 months since prior hormonal therapy
• At least 2 years since prior definitive radiotherapy
• More than 1 year since prior phytotherapeutics, including PC-SPES and saw palmetto
• More than 3 months since prior soy, cholecalciferol (> 400 IU per day), calcium, fish oil, or multivitamin supplements
• No concurrent cholecalciferol, calcium, or soy supplements
• No concurrent chemotherapy with nonstudy drugs

Patient Characteristics:

• ECOG performance status 0-2
• Life expectancy > 3 months
• 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
• No serious medical illness that would limit survival to < 3 months, or psychiatric condition that would preclude giving informed consent
• No 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
• No active, uncontrolled bacterial, viral, or fungal infection
• No hemorrhagic disorder
• No history of hypercalcemia

Expected Enrollment

Outcomes

Response of serum PSA

Changes in PSA slope
Changes in PSA doubling time
Toxicity as assessed by NCI CTCAE v3.0
Time to progression
Correlation of cholecalciferol and soy isoflavones with vitamin D receptor signaling and p21 and p27 expression in peripheral blood lymphocytes as assessed by immunoblot analysis of cell lysates and quantitative PCR

Outline

Patients receive oral cholecalciferol twice daily and a soy supplement (i.e., soy bar or shake) once daily. Treatment continues for 3-12 months in the absence of disease progression or unacceptable toxicity.

Blood samples are obtained at baseline and periodically during study to measure serum PSA, serum calcium, plasma cholecalciferol, and plasma soy isoflavone levels. Blood samples are also analyzed for expression of cholecalciferol receptor, p21, and p27 in peripheral blood lymphocytes as surrogate markers of the actions of cholecalciferol and genistein. Protein expression is assessed by immunoblot analysis of cell lysates as well as quantitative polymerase chain reaction.

Patients complete a toxicity questionnaire once each month to assess for cholecalciferol and soy supplementation toxicities and symptoms of hypercalcemia.

After completion of study therapy, patients are followed every 3 months for 1 year.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Frank Torti, MD, MPH, Protocol chair		Ph: 336-716-7971; 800-446-2255 Email: ftorti@wfubmc.edu

U.S.A.
North Carolina
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  1-800-811-8480;

Registry Information
Official Title		Phase II Trial of Vitamin D and Soy Supplementation for Biochemically Recurrent Prostate Cancer Following Definitive Local Therapy
Trial Start Date		2007-04-20
Trial Completion Date		2009-04-20 (estimated)
Registered in ClinicalTrials.gov		NCT00499408
Date Submitted to PDQ		2007-06-06
Information Last Verified		2008-09-08
NCI Grant/Contract Number		CA12197