Maurício Moreira da Silva Junior1,2,3, Diego Moreira Capibaribe1,2,3, Natalia Dalsenter Avilez1,2,3, Mehrsa Jalalizadeh1,2,3, Luiza Bortoloti Dias1,2,3, Walker W Laranja1,2,3, Fabio Guimarães1,2,3, Fabiano A Simões1,2,3, João C C Alonso1,2,3, Ronald F Rejowski1,2,3, Adriano Cintra1,2,3, Leonardo O Reis4,5,6. 1. UroScience, Faculty of Medical Sciences, State University of Campinas, UNICAMP, Campinas, SP, Brazil. 2. Center for Life Sciences, Pontifical Catholic University of Campinas, PUC-Campinas, Campinas, SP, Brazil. 3. Paulínia Municipal Hospital, Paulínia, SP, Brazil. 4. UroScience, Faculty of Medical Sciences, State University of Campinas, UNICAMP, Campinas, SP, Brazil. reisleo.l@gmail.com. 5. Center for Life Sciences, Pontifical Catholic University of Campinas, PUC-Campinas, Campinas, SP, Brazil. reisleo.l@gmail.com. 6. Paulínia Municipal Hospital, Paulínia, SP, Brazil. reisleo.l@gmail.com.
Abstract
OBJECTIVE: To evaluate the impact of the digital rectal exam (DRE) on PSA measurements and clinical decision-making. METHODS: Healthy male volunteers between 50 and 70 years old were recruited during a 30-day public screening program. PSA levels were measured using two different methods (standard enhanced chemiluminescence immunoassay-ECLIA, and novel immunochromatography assay-ICA/rapid PSA) in the same blood sample. Two blood samples were drawn; first before DRE and the second 30-40 min after DRE. The effect of DRE on PSA levels and its impact on clinical decision-making for individual patients were evaluated based on different biopsy trigger cutoffs. RESULTS: ECLIA-PSA was measured in 74 participants both pre- and 37 ± 5 min post-DRE, mean age 57.2 ± 8.3 years, and mean prostate volume 33.6 (20-80) cm3. Both total and free ECLIA-PSA increased significantly after DRE (mean increase of 0.47 and 0.26 ng/ml, respectively, both p < 0.001). Different internationally accepted biopsy triggers were reached after DRE only: 5 total PSA > 3 ng/ml, 13 increase > 0.75 ng/ml, 3 PSA density > 0.15, and 1 free/total PSA < 0.18. On two occasions, patients were pushed away from biopsy trigger after DRE due to free/total PSA > 0.18. ICA-PSA was detectable (> 2.0 ng/ml) in 5 of 45 measured samples (11%) before DRE and 13/45 (29%) after DRE, p = 0.0316. Four among five detectable ICA-PSA tests increased after DRE. CONCLUSION: Performing DRE immediately before PSA measurement might change the clinical decision-making on a significant number of occasions (roughly 1 in 3); even though the mean increase (0.47 ng/ml) looks deceivingly small. Further studies are required that include gold standard tests (biopsy, or imaging).
OBJECTIVE: To evaluate the impact of the digital rectal exam (DRE) on PSA measurements and clinical decision-making. METHODS: Healthy male volunteers between 50 and 70 years old were recruited during a 30-day public screening program. PSA levels were measured using two different methods (standard enhanced chemiluminescence immunoassay-ECLIA, and novel immunochromatography assay-ICA/rapid PSA) in the same blood sample. Two blood samples were drawn; first before DRE and the second 30-40 min after DRE. The effect of DRE on PSA levels and its impact on clinical decision-making for individual patients were evaluated based on different biopsy trigger cutoffs. RESULTS: ECLIA-PSA was measured in 74 participants both pre- and 37 ± 5 min post-DRE, mean age 57.2 ± 8.3 years, and mean prostate volume 33.6 (20-80) cm3. Both total and free ECLIA-PSA increased significantly after DRE (mean increase of 0.47 and 0.26 ng/ml, respectively, both p < 0.001). Different internationally accepted biopsy triggers were reached after DRE only: 5 total PSA > 3 ng/ml, 13 increase > 0.75 ng/ml, 3 PSA density > 0.15, and 1 free/total PSA < 0.18. On two occasions, patients were pushed away from biopsy trigger after DRE due to free/total PSA > 0.18. ICA-PSA was detectable (> 2.0 ng/ml) in 5 of 45 measured samples (11%) before DRE and 13/45 (29%) after DRE, p = 0.0316. Four among five detectable ICA-PSA tests increased after DRE. CONCLUSION: Performing DRE immediately before PSA measurement might change the clinical decision-making on a significant number of occasions (roughly 1 in 3); even though the mean increase (0.47 ng/ml) looks deceivingly small. Further studies are required that include gold standard tests (biopsy, or imaging).