Clinical Validity and Utility of Genomic-targeted Chemoprevention of PCa: Aim 4a

Summary

This study was designed to compare the efficacy, perception, decision making, and cost-effectiveness of genomic and non-genomic approaches for risk assessment of prostate cancer and for chemoprevention of prostate cancer.

Conditions

• Prostate Cancer
• Prostate Cancer, Familial
• Hereditary Prostate Cancer

Interventions

GENETIC

Genetic Risk Score: Number Format

Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.

GENETIC

Genetic Risk Score: Number + Pictograph

Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.

BEHAVIORAL

Family History: Number Format

Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.

BEHAVIORAL

Family History: Number + Pictograph

Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.

Sponsors & Collaborators

• Van Andel Research Institute

  collaborator OTHER

• Spectrum Health Medical Group

  collaborator UNKNOWN

• National Cancer Institute (NCI)

  collaborator NIH

• Wake Forest University Health Sciences

  collaborator OTHER

• Endeavor Health

  lead OTHER

Principal Investigators

• Jianfeng Xu, Dr.P.H. · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

49 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2012-06-30

Completion

2012-06-30