Purpose: To prospectively assess the health-related quality of life (HRQOL) and changes in HRQOL during the first year after permanent source interstitial brachytherapy (PIB). Methods and Materials: Thirty-one men treated with PIE between September 1997 and March 1998 completed a quality of life (functional assessment of cancer therapy-prostate: FACT-P) and a urinary symptom questionnaire (international prostate symptom score: IPSS) prior to treatment (TO), 1 month (T1), 3 months (T3), 6 months (T6), and 12 months (T12) following PIB, All participants were treated with I-125 alone. Repeated measures analyses of variance (ANOVA) were conducted on all quality of life and urinary outcome measures for all 31 patients at all time points. Results: The median age of the study population was 66 (range 51-80), All men had clinical T1c-T2b prostate cancer. The Gleason score was less than or equal to 6 in 27/31 (87%), Median pretreatment PSA was 7.8 ng/ml (range 1.1-20.6), The mean score (and standard deviation) at TO, T1, T3, T6, and T12 for the FACT-P questionnaire are as follows: 140.5 (13.5), 132.7 (15.3), 137.2 (17.4), 140.1 (16.0), and 142.4 (15.3), For the global test across time, statistically significant differences were observed for the cumulative scores of FACT-P (p < 0.0012), The decrease in HRQOL was most marked 1 month following PIE. Examination of the subscales within the FACT-P instrument demonstrated statistically significant changes over time for the following: physical well-being (PWB), functional well-being (FWB), and prostate cancer (PCS), By 3 months, all HRQOL measures had returned to near baseline. The mean score (and standard deviation) at TO, T1, T3, T6, and T12 for the IPSS questionnaire are as follows: 8.3 (5.5), 18.4 (8.0), 15.7 (7.4), 13.7 (7.4), and 10.2 (5.7). For the global test across time, statistically significant differences were observed for the IPSS scores (p < 0.0001). The maximum increase in IPSS occurred 1 month following PIE. Conclusion: The results of this preliminary analysis suggest that clinically meaningful decreases in HRQOL, as measure by the FACT-P instrument, are evident within weeks after PIE. By 3 months, however, FACT-P scores return to near baseline levels. A validated instrument designed to measure urinary symptoms (IPSS) demonstrates that moderate to severe urinary symptoms persist for at least 3-6 months following PIE. One year following PIE, the scores on the FACT-P and IPSS questionnaires had returned to baseline. (C) 2000 Elsevier Science Inc.