N/A N=700 Randomized Triple-blind Basic Science

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

Prostate Cancer · Prostate Cancer, Familial · Hereditary Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02381015 ↗

Enrolled (actual)

700

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Number of Participants Who Had Prostate Specific Antigen (PSA) Discussion With Physician at 3 Months, Measured by Survey — 34; 30; 25; 22 participants — p=0.29

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Genetic Risk Score: Number Format (Genetic); Genetic Risk Score: Number + Pictograph (Genetic); Family History: Number Format (Behavioral); Family History: Number + Pictograph (Behavioral)
Age: Adult · 40+ yrs
Sex: Male
Sponsor: Endeavor Health
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Had Prostate Specific Antigen (PSA) Discussion With Physician at 3 Months, Measured by Survey	34; 30; 25; 22	0.29
PRIMARY Number of Participants Who Had PSA Testing at 3 Months, Measured by Survey	8; 7; 4; 3	0.35
PRIMARY Number of Participants Who Had PSA Testing at 3 Years, Measured by Medical Records	45; 46; 29; 40	0.29
SECONDARY Anxiety, Measured by State-trait Anxiety Inventory (STAI)	15.25; 15.95; 14.92; 15.12	0.49
SECONDARY Accuracy of Immediate Recall of Risk Information Measured by Survey	0.65; 0.72; 0.26; 1.0	0.42
SECONDARY Accuracy of Recall of Risk Information at 3 Months Measured by Survey	3.30; 3.78; 4.43; 4.38	0.33

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.

Eligibility Criteria

Inclusion Criteria

age 40 to 49 years, self-defined Caucasian background, and no prior prostate specific antigen (PSA) screening nor prostate cancer (PCa) diagnosis.

Exclusion Criteria

outside of age range, or not self defined Caucasian background, or a prior history of PSA screening or PCa diagnosis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02381015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.