N/A
Completed N=700
Clinical Validity and Utility of Genomic-targeted Chemoprevention of PCa: Aim 4a
Prostate Cancer · Prostate Cancer, Familial · Hereditary Prostate Cancer
Source: ClinicalTrials.gov NCT02381015 ↗
Enrolled (actual)
700
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: 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
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.
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 |
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
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. Informational only — not medical advice.