Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer

Shipley, William U.; Seiferheld, Wendy; Lukka, Himanshu R.; Major, Pierre P.; Heney, Niall M.; Grignon, David J.; Sartor, Oliver; Patel, Maltibehn P.; Bahary, Jean-Paul; Zietman, Anthony L.; Pisansky, Thomas M.; Zeitzer, Kenneth L.; Lawton, Colleen A.F.; Feng, Felix Y.; Lovett, Richard D.; Balogh, Alexander G.; Souhami, Luis; Rosenthal, Seth A.; Kerlin, Kevin J.; Dignam, James J.; Pugh, Stephanie L.; Sandler, Howard M.

doi:10.1056/nejmoa1607529

Cited by 665Prostate Cancer Diagnosis and TreatmentProstate Cancer Treatment and ResearchBreast Cancer Treatment Studies

Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer

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Shipley, William U., Seiferheld, Wendy, Lukka, Himanshu R., Major, Pierre P., Heney, Niall M., Grignon, David J., Sartor, Oliver, Patel, Maltibehn P. +14 more·2017·New England Journal of Medicine

DOI 10.1056/nejmoa1607529PMC PMC5444881

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Abstract

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 survival.
“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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Surgery vs Radiotherapy in the Management of Biopsy Gleason Score 9-10 Prostate Cancer and the Risk of Mortality
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Radiation Therapy for Prostate Cancer
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Recent Advances in the Management of High-Risk Localized Prostate Cancer: Local Therapy, Systemic Therapy, and Biomarkers to Guide Treatment Decisions
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Risk of Upgrading and Upstaging Among 10 000 Patients with Gleason 3 + 4 Favorable Intermediate-risk Prostate Cancer
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Patterns of failure after radical prostatectomy in prostate cancer – implications for radiation therapy planning after 68Ga-PSMA-PET imaging
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Toxicity and Biochemical Outcomes of Dose-Intensified Postoperative Radiation Therapy for Prostate Cancer: Results of a Randomized Phase III Trial
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DNA Damage Response in Prostate CancerPreprint
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Androgen‐deprivation therapy, dementia, and cognitive dysfunction in men with prostate cancer: How much smoke and how much fire?
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Retracted
The contemporary management of prostate cancer
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Delineating sites of failure following post-prostatectomy radiation treatment using 68 Ga-PSMA-PET
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Exploratory cost-effectiveness analysis of 68Gallium-PSMA PET/MRI-based imaging in patients with biochemical recurrence of prostate cancer
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Intermediate Endpoints After Postprostatectomy Radiotherapy: 5-Year Distant Metastasis to Predict Overall Survival
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Management of Biochemically Recurrent Prostate Cancer: Ensuring the Right Treatment of the Right Patient at the Right Time
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A Comprehensive Assessment of 68Ga-PSMA-11 PET in Biochemically Recurrent Prostate Cancer: Results from a Prospective Multicenter Study on 2,005 Patients
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Radiotherapy for node-positive prostate cancer: 2019 Recommendations of the Australian and New Zealand Radiation Oncology Genito-Urinary group
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Patient-derived, three-dimensional spheroid cultures provide a versatile translational model for the study of organ-confined prostate cancer
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The complementary value of intraoperative fluorescence imaging and Raman spectroscopy for cancer surgery: combining the incompatibles
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Metabolic response to radiation therapy in cancer
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Randomised Trial of No, Short-term, or Long-term Androgen Deprivation Therapy with Postoperative Radiotherapy After Radical Prostatectomy: Results from the Three-way Comparison of RADICALS-HD (NCT00541047)
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Self-citation
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Long-Term Results of NRG/RTOG 9601, a Randomized Trial of Radiation With or Without Antiandrogens in Patients Receiving Salvage Prostate Bed Radiation Therapy Postprostatectomy
Lukka, H. R., Pugh, S. L., Shipley, W. U., Major, P. P., Sartor, O., Dayes, I. S., Bahary, J.-P., Efstathiou, J. A., Pisansky, T. M., Zeitzer, K. L., et al. (2025) · International Journal of Radiation Oncology*Biology*Physics · doi:10.1016/j.ijrobp.2025.07.1416 · Cited by 11 · see citing works
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Antiandrogen With Salvage RT Can Prolong Survival in Prostate Cancer
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Bicalutamide with radiotherapy for prostate cancer
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Long-term results of radiation with or without anti-androgens (AAT) in patients receiving salvage prostate bed radiation therapy (sRT) post prostatectomy.
Lukka, H. R., Pugh, S. L., Shipley, W. U., Major, P. P., Sartor, O. A., Dayes, I. S., Bahary, J.-P., Efstathiou, J. A., Pisansky, T. M., Zeitzer, K. L., et al. (2024) · Journal of Clinical Oncology · doi:10.1200/jco.2024.42.4_suppl.320
Self-citation

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: Shipley, William U.
Major, Pierre P.
Grignon, David J.
Sartor, Oliver
Bahary, Jean-Paul
Zietman, Anthony L.
Pisansky, Thomas M.
Zeitzer, Kenneth L.
Feng, Felix Y.
Rosenthal, Seth A.
Dignam, James J.
Pugh, Stephanie L.
Sandler, Howard M.
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
DOI: 10.1056/nejmoa1607529
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 › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › 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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Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer

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