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Randomized Trial Comparing Conventional-Dose With High-Dose Conformal Radiation Therapy in Early-Stage Adenocarcinoma of the Prostate: Long-Term Results From Proton Radiation Oncology Group/American College of Radiology 95-09
Open accessAbstract
Purpose: To test the hypothesis that increasing radiation dose delivered to men with early-stage prostate cancer improves clinical outcomes. Patients and Methods: Men with T1b-T2b prostate cancer and prostate-specific antigen ≤ 15 ng/mL were randomly assigned to a total dose of either 70.2 Gray equivalents (GyE; conventional) or 79.2 GyE (high). No patient received androgen suppression therapy with radiation. Local failure (LF), biochemical failure (BF), and overall survival (OS) were outcomes. Results: A total of 393 men were randomly assigned, and median follow-up was 8.9 years. Men receiving high-dose radiation therapy were significantly less likely to have LF, with a hazard ratio of 0.57. The 10-year American Society for Therapeutic Radiology and Oncology BF rates were 32.4% for conventional-dose and 16.7% for high-dose radiation therapy (P < .0001). This difference held when only those with low-risk disease (n = 227; 58% of total) were examined: 28.2% for conventional and 7.1% for high dose (P < .0001). There was a strong trend in the same direction for the intermediate-risk patients (n = 144; 37% of total; 42.1% v 30.4%, P = .06). Eleven percent of patients subsequently required androgen deprivation for recurrence after conventional dose compared with 6% after high dose (P = .047). There remains no difference in OS rates between the treatment arms (78.4% v 83.4%; P = .41). Two percent of patients in both arms experienced late grade ≥ 3 genitourinary toxicity, and 1% of patients in the high-dose arm experienced late grade ≥ 3 GI toxicity. Conclusion: This randomized controlled trial shows superior long-term cancer control for men with localized prostate cancer receiving high-dose versus conventional-dose radiation. This was achieved without an increase in grade ≥ 3 late urinary or rectal morbidity.
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Cox, D. R. (1972) · Journal of the Royal Statistical Society Series B: Statistical Methodology · doi:10.1111/j.2517-6161.1972.tb00899.x · Cited by 39,793
Nonparametric Estimation from Incomplete Observations
Kaplan, E. L., & Meier, P. (1958) · Journal of the American Statistical Association · doi:10.1080/01621459.1958.10501452 · Cited by 39,158
A Proportional Hazards Model for the Subdistribution of a Competing Risk
Fine, J. P., & Gray, R. J. (1999) · Journal of the American Statistical Association · doi:10.1080/01621459.1999.10474144 · Cited by 14,290
Zietman, A. L., DeSilvio, M. L., Slater, J. D., Rossi, C. J., Miller, D. W., Adams, J. A., & Shipley, W. U. (2005) · JAMA · doi:10.1001/jama.294.10.1233 · Cited by 1,224
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Mottet, N., Bellmunt, J., Bolla, M., Briers, E., Cumberbatch, M. G., De Santis, M., Fossati, N., Gross, T., Henry, A. M., Joniau, S., et al. (2017) · European Urology · doi:10.1016/j.eururo.2016.08.003 · Cited by 3,227
Proton therapy – Present and future
Mohan, R., & Grosshans, D. (2017) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2016.11.006 · Cited by 608
Metadata
- Authors
- Zietman, A. L., Bae, K., Slater, J. D., Shipley, W. U., Efstathiou, J. A., Coen, J. J., Bush, D. A., Lunt, M., Spiegel, D. Y., Skowronski, R., Jabola, B. R., & Rossi, C. J.
- Venue
- Journal of Clinical Oncology
- Published
- 2010-03-01
- Volume
- 28
- Issue
- 7
- Pages
- 1106-1111
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2098733695
- Cited by
- 735
- References
- 4
- FWCI
- 51.41
- Type
- journal article
- Language
- en
- Open access
- green
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- CoChat. (2026). Citation check: Randomized Trial Comparing Conventional-Dose With High-Dose Conformal Radiation Therapy in Early-Stage Adenocarcinoma of the Prostate: Long-Term Results From Proton Radiation Oncology Group/American College of Radiology 95-09. https://app.cochat.ai/papers/10.1200/jco.2009.25.8475
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- Zietman, A. L., Bae, K., Slater, J. D., Shipley, W. U., Efstathiou, J. A., Coen, J. J., Bush, D. A., Lunt, M., Spiegel, D. Y., Skowronski, R., Jabola, B. R., & Rossi, C. J. (2010). Randomized Trial Comparing Conventional-Dose With High-Dose Conformal Radiation Therapy in Early-Stage Adenocarcinoma of the Prostate: Long-Term Results From Proton Radiation Oncology Group/American College of Radiology 95-09. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2009.25.8475
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