Steven J Frank1, Thomas J Pugh2, Pierre Blanchard3, Usama Mahmood4, William J Graber5, Rajat J Kudchadker6, John W Davis5, Jeri Kim7, Haesun Choi8, Patricia Troncoso9, Deborah A Kuban4, Seungtaek Choi4, Sean McGuire4, Karen E Hoffman4, Hsiang-Chun Chen10, Xuemei Wang10, David A Swanson5. 1. Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. Electronic address: sjfrank@mdanderson.org. 2. Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado. 3. Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas; Department of Radiation Oncology, Institut Gustave Roussy, Villejuif, France. 4. Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. 5. Department of Urology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. 6. Department of Radiation Physics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. 7. Department of Genitourinary Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. 8. Department of Diagnostic Radiology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. 9. Department of Pathology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. 10. Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Abstract
PURPOSE: To report the efficacy, physician-reported toxicity, and patient-reported outcomes of men with intermediate-risk prostate cancer after brachytherapy in a prospective phase 2 trial. METHODS AND MATERIALS: This prospective phase 2 trial involved 300 patients with previously untreated prostate cancer treated from 2006 through 2013. Eligible patients had ≤cT2b (T3 excluded according to magnetic resonance imaging), Gleason score (GS) 6 with prostate-specific antigen (PSA) level 10-15 ng/mL, or GS 7 with PSA <10 ng/mL, and were treated with prostate brachytherapy (without hormonal therapy). RESULTS: Median patient age was 64.9 years; 3.7% had GS 6, 78.7% had GS 7 (3+4), and 17.7% had GS 7 (4+3). Median follow-up time was 5.1 years. Median PSA at 5 years was 0.01 ng/mL (range, 0-6.0 ng/mL). Ten biochemical failures occurred, for a 5-year freedom from biochemical failure rate of 97.3% (95% confidence interval [CI], 95.1-99.5), and 16 patients died, only 1 from prostate cancer, for 5-year rates of overall and biochemical progression-free survival of 94.9% (95% CI, 92.1-97.9) and 92.7% (95% CI, 89.3-96.2%). Four patients had late grade 3 genitourinary toxicity, and 2 patients had late grade 3 rectal toxicity; no grade 4 or 5 toxicity was observed. Rates of "moderate or big problems" at 4 years were 7.4% for urinary (vs 0.4% at baseline), 2.9% bowel (vs 0.4%), and 29.7% sexual function (vs 19.7%). Most men were "satisfied or extremely satisfied" (91% at 2 years after treatment and 93% at 4 years). CONCLUSIONS: Brachytherapy monotherapy is safe and effective and leads to good quality of life for some men with localized intermediate-risk prostate cancer.
PURPOSE: To report the efficacy, physician-reported toxicity, and patient-reported outcomes of men with intermediate-risk prostate cancer after brachytherapy in a prospective phase 2 trial. METHODS AND MATERIALS: This prospective phase 2 trial involved 300 patients with previously untreated prostate cancer treated from 2006 through 2013. Eligible patients had ≤cT2b (T3 excluded according to magnetic resonance imaging), Gleason score (GS) 6 with prostate-specific antigen (PSA) level 10-15 ng/mL, or GS 7 with PSA <10 ng/mL, and were treated with prostate brachytherapy (without hormonal therapy). RESULTS: Median patient age was 64.9 years; 3.7% had GS 6, 78.7% had GS 7 (3+4), and 17.7% had GS 7 (4+3). Median follow-up time was 5.1 years. Median PSA at 5 years was 0.01 ng/mL (range, 0-6.0 ng/mL). Ten biochemical failures occurred, for a 5-year freedom from biochemical failure rate of 97.3% (95% confidence interval [CI], 95.1-99.5), and 16 patients died, only 1 from prostate cancer, for 5-year rates of overall and biochemical progression-free survival of 94.9% (95% CI, 92.1-97.9) and 92.7% (95% CI, 89.3-96.2%). Four patients had late grade 3 genitourinary toxicity, and 2 patients had late grade 3 rectal toxicity; no grade 4 or 5 toxicity was observed. Rates of "moderate or big problems" at 4 years were 7.4% for urinary (vs 0.4% at baseline), 2.9% bowel (vs 0.4%), and 29.7% sexual function (vs 19.7%). Most men were "satisfied or extremely satisfied" (91% at 2 years after treatment and 93% at 4 years). CONCLUSIONS: Brachytherapy monotherapy is safe and effective and leads to good quality of life for some men with localized intermediate-risk prostate cancer.
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