The STHLM3-model, Risk-based Prostate Cancer Testing Identifies Men at High Risk Without Inducing Negative Psychosocial Effects

BACKGROUND: The new STHLM3 test, combining protein markers, genetic markers, and clinical data to assess a man’s prostate cancer (PCa) risk, has been investigated in Sweden within the frame of the STHLM3 trial. OBJECTIVE: To assess whether the STHLM3 test influences men’s worry level, PCa knowledge, attitude, and health-related quality of life (HRQoL). DESIGN, SETTING, AND PARTICIPANTS: Invitations with login to the web survey were mailed to 10 000 men, 50–69 yr of age, who were eligible for the STHLM3 trial. The survey was sent 3 mo before invitation to the STHLM3 trial (baseline) and 5 mo after STHLM3 (follow-up). At baseline, the men were unaware of the upcoming invitation to STHLM3. The survey covered the following: PCa-specific worry and perceived vulnerability, knowledge about PCa, attitude toward PCa testing and health behavior, and HRQoL OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Survey scores were compared between baseline and follow-up by using the nonparametric Wilcoxon-signed rank tests for paired samples. Analysis of covariance was performed for PCa risk group comparisons. RESULTS AND LIMITATIONS: A total of 994 men (10%) responded to our survey at baseline and follow-up, and were assessed as follows: low risk: 421 men; intermediate risk: 421 men; and high risk:152, of whom 59 were diagnosed with PCa after further investigation. In men assessed as having low and intermediate risk, level of worrying decreased at follow-up (p < 0.001), whereas no changes were observed in men at high risk. Moreover, no HRQoL changes were observed over time. The low response rate is the main limitation. CONCLUSIONS: We found that the STHLM3 model, a risk-based PCa test, showed no negative impact on the well-being of men. PATIENT SUMMARY: Since our results suggest that the risk-based screening as used in STHLM3 did not induce negative psychological effects on the participants, we can recommend this risk-based approach for population-based prostate cancer screening.