Comparison of Conventional-Dose vs High-Dose Conformal Radiation Therapy in Clinically Localized Adenocarcinoma of the Prostate: A Randomized Controlled Trial
Abstract
CONTEXT: Clinically localized prostate cancer is very prevalent among US men, but recurrence after treatment with conventional radiation therapy is common. OBJECTIVE: To evaluate the hypothesis that increasing the radiation dose delivered to men with clinically localized prostate cancer improves disease outcome. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial of 393 patients with stage T1b through T2b prostate cancer and prostate-specific antigen (PSA) levels less than 15 ng/mL randomized between January 1996 and December 1999 and treated at 2 US academic institutions. Median age was 67 years and median PSA level was 6.3 ng/mL. Median follow-up was 5.5 (range, 1.2-8.2) years. INTERVENTION: Patients were randomized to receive external beam radiation to a total dose of either 70.2 Gy (conventional dose) or 79.2 Gy (high dose). This was delivered using a combination of conformal photon and proton beams. MAIN OUTCOME MEASURE: Increasing PSA level (ie, biochemical failure) 5 years after treatment. RESULTS: The proportions of men free from biochemical failure at 5 years were 78.8% [corrected] (95% confidence interval, 73.1%-84.6%) [corrected] for conventional-dose and 91.3% [corrected] (95% confidence interval, 87.2%-95.4%) [corrected] for high-dose therapy (P<.001), a 59% [corrected] reduction in the risk of failure. The advantage to high-dose therapy was statistically significant [corrected] in both the low-risk subgroup [corrected] (risk reduction, 84% [P<.001]) [corrected] There has been no significant difference in overall survival rates between the treatment groups. Only 1% of patients receiving conventional-dose and 2% receiving high-dose radiation experienced acute urinary or rectal morbidity of Radiation Therapy Oncology Group (RTOG) grade 3 or greater. So far, only 2% and 1%, respectively, have experienced late morbidity of RTOG grade 3 or greater. CONCLUSIONS: Men with clinically localized prostate cancer have a lower risk of biochemical failure if they receive high-dose rather than conventional-dose conformal radiation. This advantage was achieved without any associated increase in RTOG grade 3 acute or late urinary or rectal morbidity.
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Advances in radiation oncology have improved outcomes in a number of different cancers.
“This has resulted in improved outcomes in a number of different cancers (2, 342–350).”
From Adrenocortical carcinoma (2014) · cites this paper as [350]
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- Authors
- Zietman, A. L., DeSilvio, M. L., Slater, J. D., Rossi, C. J., Miller, D. W., Adams, J. A., & Shipley, W. U.
- Affiliations
- Harvard University (US)
- American Medical Association (US)
- Corresponding author
- Zietman, Anthony L.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2005-09-14
- Volume
- 294
- Issue
- 10
- Pages
- 1233
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W1996809772
- Cited by
- 1,224
- References
- 26
- Citations by year
- 2026: 10 · 2025: 12 · 2024: 16 · 2023: 17 · 2022: 24 · 2021: 31 · 2020: 28 · 2019: 45 · 2018: 36 · 2017: 56 · 2016: 55 · 2015: 60 · 2014: 71 · 2013: 100 · 2012: 85
- FWCI
- 64.17
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Cancer Institute (P01CA021239, P01 CA 21239)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
- Physical Sciences › Physics and Astronomy › Radiation › Advanced Radiotherapy Techniques
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Keywords
- localized prostate cancer, prostate adenocarcinoma, high-dose radiotherapy, conformal radiotherapy, proton therapy, external beam radiotherapy, biochemical recurrence, prostate-specific antigen, overall survival, late radiation toxicity, low-risk prostate cancer, dose escalation, recurrence after radiotherapy
- MeSH terms
- Adenocarcinoma, Aged, Humans, Male, Middle Aged, Prostatic Neoplasms, Radiotherapy Dosage, Prostate-Specific Antigen, Radiotherapy, Conformal
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