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Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer
Open accessAbstract
BACKGROUND: Salvage radiation therapy is often necessary in men who have undergone radical prostatectomy and have evidence of prostate-cancer recurrence signaled by a persistently or recurrently elevated prostate-specific antigen (PSA) level. Whether antiandrogen therapy with radiation therapy will further improve cancer control and prolong overall survival is unknown. METHODS: In a double-blind, placebo-controlled trial conducted from 1998 through 2003, we assigned 760 eligible patients who had undergone prostatectomy with a lymphadenectomy and had disease, as assessed on pathological testing, with a tumor stage of T2 (confined to the prostate but with a positive surgical margin) or T3 (with histologic extension beyond the prostatic capsule), no nodal involvement, and a detectable PSA level of 0.2 to 4.0 ng per milliliter to undergo radiation therapy and receive either antiandrogen therapy (24 months of bicalutamide at a dose of 150 mg daily) or daily placebo tablets during and after radiation therapy. The primary end point was the rate of overall survival. RESULTS: The median follow-up among the surviving patients was 13 years. The actuarial rate of overall survival at 12 years was 76.3% in the bicalutamide group, as compared with 71.3% in the placebo group (hazard ratio for death, 0.77; 95% confidence interval, 0.59 to 0.99; P=0.04). The 12-year incidence of death from prostate cancer, as assessed by means of central review, was 5.8% in the bicalutamide group, as compared with 13.4% in the placebo group (P<0.001). The cumulative incidence of metastatic prostate cancer at 12 years was 14.5% in the bicalutamide group, as compared with 23.0% in the placebo group (P=0.005). The incidence of late adverse events associated with radiation therapy was similar in the two groups. Gynecomastia was recorded in 69.7% of the patients in the bicalutamide group, as compared with 10.9% of those in the placebo group (P<0.001). CONCLUSIONS: The addition of 24 months of antiandrogen therapy with daily bicalutamide to salvage radiation therapy resulted in significantly higher rates of long-term overall survival and lower incidences of metastatic prostate cancer and death from prostate cancer than radiation therapy plus placebo. (Funded by the National Cancer Institute and AstraZeneca; RTOG 9601 ClinicalTrials.gov number, NCT00002874 .).
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“Multiple phase 3 clinical trials have demonstrated the benefit of AR-targeted therapies on patient survival9–18.”
From Genome-scale CRISPR screens identify PTGES3 as a direct modulator of androgen receptor function in advanced prostate cancer (2025) · cites this paper as [13]
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Metadata
- Authors
- Shipley, W. U., Seiferheld, W., Lukka, H. R., Major, P. P., Heney, N. M., Grignon, D. J., Sartor, O., Patel, M. P., Bahary, J.-P., Zietman, A. L., Pisansky, T. M., Zeitzer, K. L., Lawton, C. A. F., Feng, F. Y., Lovett, R. D., Balogh, A. G., Souhami, L., Rosenthal, S. A., Kerlin, K. J., Dignam, J. J., Pugh, S. L., & Sandler, H. M.
- Affiliations
- Cedars-Sinai Medical Center (US)
- Tulane University (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-02-02
- Volume
- 376
- Issue
- 5
- Pages
- 417-428
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5444881
- OpenAlex
- W2585109238
- Cited by
- 663
- References
- 29
- Citations by year
- 2026: 32 · 2025: 54 · 2024: 65 · 2023: 50 · 2022: 63 · 2021: 84 · 2020: 81 · 2019: 86 · 2018: 78 · 2017: 68
- FWCI
- 70.79
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (UG1CA189867, U10CA180868, U10CA180801, U10CA021661, U10CA180822)
- Topics
- Health Sciences › Medicine › Urology › Prostate Cancer Diagnosis and Treatment
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Prostate Cancer Treatment and Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Keywords
- recurrent prostate cancer, salvage radiotherapy, antiandrogen therapy, bicalutamide, prostate-specific antigen, radical prostatectomy, overall survival, metastatic prostate cancer, gynecomastia, androgen deprivation therapy, lymph node dissection, long-term follow-up
- MeSH terms
- Aged, Aged, 80 and over, Androgen Antagonists, Anilides, Combined Modality Therapy, Double-Blind Method, Follow-Up Studies, Gynecomastia, Humans, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Neoplasm Staging, Nitriles, Prostatectomy, Prostatic Neoplasms, Radiotherapy, Tosyl Compounds, Incidence, Survival Rate, Kaplan-Meier Estimate
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