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

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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., 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.·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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Yang, Y., Cheng, J., Liao, X., Chen, J., Wu, J., Wu, C., Liu, Y., Han, X., & Mei, H. (2025) · BMC Urology · doi:10.1186/s12894-025-01985-3 · Cited by 1
“However, the optimal duration of ADT remains debated, particularly for node-negative patients [22].”
Open Retropubic Radical Prostatectomy: Experience in Cameroon
Guy, E. N. F., Barthelemy, M. M. J., Cédrick, F. J., Wafo, D. P., Ngandeu, J. M., Kpanou, Y. A., Patrick, K., & Joseph, F. P. (2025) · International Journal of Clinical Urology · doi:10.11648/j.ijcu.20250902.30 · Cited by 1
18F-PSMA-PET/CT in comparison with whole-body MRI and combination of conventional CT and bone scintigraphy for detection of recurrent disease in prostate cancer patients with rising PSA levels after initial definitive treatment
Murata, S., Moribata, Y., Akamatsu, S., Kido, A., Himoto, Y., Kurata, Y., Otani, T., Sumiyoshi, T., Saito, R., Ogata, T., et al. (2026) · International Journal of Clinical Oncology · doi:10.1007/s10147-026-02958-8 · Cited by 1
“Detecting recurrent lesions with imaging is vital, as survival differs between local recurrence and distant metastasis [7–9].”
FORMULA-509: A Multicenter Randomized Trial of Postprostatectomy Salvage Radiotherapy and 6 months of a GNRH Agonist with Either Bicalutamide or Abiraterone Acetate plus Prednisone and Apalutamide
Nguyen, P. L., Kollmeier, M. A., Rathkopf, D. E., Hoffman, K. E., Zurita, A. J., Spratt, D. E., Dess, R. T., Liauw, S. L., Szmulewitz, R. Z., Einstein, D. J., et al. (2026) · European Urology · doi:10.1016/j.eururo.2025.12.001 · Cited by 1
Self-citation
Outcomes of a Phase II Interventional Clinical Trial of Prostate Bed Stereotactic Body Radiation Therapy for Prostate Cancer With High-Risk Features Following Radical Prostatectomy
Vargas, C. E., Voss, M. M., Dodoo, C., Niska, J. R., Wong, W. W., Zhu, A., Keole, S. R., Rwigema, J. M., Davis, B. J., Stish, B. J., et al. (2026) · International Journal of Radiation Oncology*Biology*Physics · doi:10.1016/j.ijrobp.2026.02.194 · Cited by 1
A High-Sensitive Photothermal-Readout Strategy for Commercial Lateral Flow Immunoassays with an Optical Microfiber Mach–Zehnder Interferometer
Xu, B., Chen, C., Liang, L., Sun, L.-P., & Guan, B. (2026) · Analytical Chemistry · doi:10.1021/acs.analchem.5c06666 · Cited by 1
The Swedish national guidelines on prostate cancer: recurrent, metastatic and castration resistant disease
Stranne, J., Axén, E., Ola Bratt, A., Carlsson, S., Kindblom, J., Kohestani, K., Kristiansen, A., Lissbrant, I. F., Moise, G., Nemlander, E., et al. (2026) · Scandinavian Journal of Urology · doi:10.2340/sju.v61.45715 · Cited by 1
Salvage Radiotherapy Confers an Overall Survival Advantage in Biochemical Recurrence of Prostate Cancer: Evidence from the International PROMISE Registry
Guberina, N., Karpinski, M. J., Guberina, M., Hoberück, S., Miederer, M., Hölscher, T., Rauscher, I., Eiber, M., Nguyen, A. T., Theus, L., et al. (2026) · Journal of Nuclear Medicine · doi:10.2967/jnumed.125.271770 · Cited by 1
Influence of Adverse Pathologic Features on Potential Benefit of Hormone Therapy Use with Postoperative Radiotherapy in Recurrent Prostate Cancer: An Individual Patient Data Meta-analysis
Kishan, A. U., Sun, Y., Parker, C. C., Sargos, P., Sydes, M. R., Chabaud, S., Brihoum, M., Supiot, S., Latorzeff, I., Guerif, S. G., et al. (2026) · European Urology · doi:10.1016/j.eururo.2026.07.013 · Cited by 1
Self-citation
Prognostic and Predictive Value of a Breast Cancer Expression Signature in Localized Prostate Cancer
Abida, W. M., & Scher, H. I. (2017) · JAMA Oncology · doi:10.1001/jamaoncol.2017.0750 · Cited by 1
Outcomes of post‐prostatectomy radiotherapy at a Regional Cancer Centre
Nicholls, L., Winter, A., Harwood, A., Plank, A. W., Bagga, P., Wong, W., & Khoo, E. (2017) · Journal of Medical Radiation Sciences · doi:10.1002/jmrs.240 · Cited by 1
“It has recently been shown that the use of 24 months of concurrent and adjuvant bicalutamide in high risk salvage patients improved overall survival and reduced incidence of metastatic disease.(28) Even in the era of ultra-sensitive PSA assays, patients salvaged early (PSA < 0.”
Managing Cancer Relapse After Radical Prostatectomy
Rodriguez, J. F., Liauw, S. L., & Eggener, S. E. (2017) · Urologic Clinics of North America · doi:10.1016/j.ucl.2017.07.011 · Cited by 1
Recent advances in radiation oncology: multimodal targeting of high risk and recurrent prostate cancer
Kwok, Y., Kaiser, A., Rice, S. R., Cohen, R. J., & Mishra, M. V. (2018) · Current Opinion in Oncology · doi:10.1097/cco.0000000000000440 · Cited by 1
Adjuvant and Salvage Radiation Therapy for Prostate Cancer After Radical Prostatectomy
Lee, J. H., & Kim, S. H. (2018) · Springer eBooks · doi:10.1007/978-981-10-6943-7_12 · Cited by 1
Libro Blanco de la Carga Socioeconómica del Cáncer de Próstata en España
Revilla, B. A., Fernández, M. D. A., Bortoló, J. M. C., Comesaña, J. G., Fuentes, M. D. F., Hidalgo‐Vega, Á., Medina, J. M., Rodríguez, J. A. M., Moreno, J. O., Peña-Longobardo, L. M., et al. (2018) · Fundación Weber eBooks · doi:10.37666/l7-2018 · Cited by 1
Management of Positive Surgical Margins After Radical Prostatectomy
Tüfek, İ., Argun, Ö. B., Öbek, C., & Kural, A. R. (2021) · Springer eBooks · doi:10.1007/978-3-030-53594-0_95 · Cited by 1
Clinical Recommendation for Diagnostics, Treatment and Monitoring of Patients with Prostate Cancer
Solarić, M., Fröbe, A., Huić, D., Zahirović, D., Kaštelan, Ž., Bulimbašić, S., Tomašković, I., Kuliš, T., Gamulin, M., Jakšić, B., et al. (2019) · Liječnički vjesnik · doi:10.26800/lv-141-11-12-41 · Cited by 1
Narrative review of PET/CT performances at biochemical recurrence in prostate cancer after radical prostatectomy and impact on patient disease management
Lasserre, M., Sargos, P., Barret, É., Beauval, J., Brureau, L., Créhange, G., Dariane, C., Fiard, G., Fromont, G., Mathiéu, R., et al. (2022) · The French Journal of Urology · doi:10.1016/s1166-7087(22)00173-7 · Cited by 1
Salvage Involved-Field and Extended-Field Radiation Therapy in Positron Emission Tomography–Positive Nodal Recurrent Prostate Cancer: Outcomes and Patterns of Failure
Pêtre, A., Quivrin, M., Briot, N., Boustani, J., Martin, E., Bessières, I., Cochet, A., & Créhange, G. (2022) · Advances in Radiation Oncology · doi:10.1016/j.adro.2022.101040 · Cited by 1
“For BF in prostate cancer, the addition of 6 to 24 months of ADT to postoperative radiation therapy compared with radiation therapy alone for microscopic residual disease led to benefits in PFS and overall survival.(26,27) A favorable effect could also be expected in nodal recurrences.”
Method
Risk factors for prostate-specific antigen persistence in pT3aN0 prostate cancer after robot-assisted laparoscopic radical prostatectomy: a retrospective study
Kim, J. S., Chung, J. H., Song, W., Kang, M., Sung, H. H., Jeon, H. G., Jeong, B. C., Seo, S. I., Lee, H. M., & Jeon, S. S. (2023) · Journal of Yeungnam Medical Science · doi:10.12701/jyms.2023.00234 · Cited by 1
“PSA persistence after RP has been defined in past studies by several criteria, such as a PSA level of 0.03, 0.1, or 0.5 ng/mL [13-17].”
MethodInfluential
Prostate‐specific membrane antigen positron emission tomography detected local failure after post‐prostatectomy radiation therapy: Low rates of out‐of‐field recurrence validates current Australian prostate bed contouring guidelines
Shakespeare, T. P., Yap, S. Z. L., Hsieh, M. T., Tahir, A. R. M., & Armstrong, S. (2023) · Journal of Medical Imaging and Radiation Oncology · doi:10.1111/1754-9485.13556 · Cited by 1
“11 and the GETUG-AFU 16 trial.”
Study of prostate-specific antigen levels during salvage radiotherapy after prostate cancer surgery
Aizawa, T., Maebayashi, T., Ishibashi, N., Sakaguchi, M., Sato, A., & Yamaguchi, K. (2023) · BMC Urology · doi:10.1186/s12894-023-01323-5 · Cited by 1
“In addition, recent clinical studies have shown that a combination of salvage RT and hormone therapy is associated with improved outcomes [17–19].”
Background
Avoiding prostate bed radiation for the PSMA-PET detected nodal recurrence patient post prostatectomy
Challis, B., Kneebone, A. B., Eade, T., Guo, L., Atyeo, J., Brown, C. S. B., & Hruby, G. (2024) · Clinical and Translational Radiation Oncology · doi:10.1016/j.ctro.2024.100896 · Cited by 1
Utilization of Radical Prostatectomy Versus Radiation Therapy for Gleason Grade Group 5 Prostate Cancer Before and After USPSTF Grade D Recommendation Against Prostate‐Specific Antigen Screening in 2012
McGinnis, H. S., Corriher, T. J., Janopaul-Naylor, J. R., Goyal, S., Liu, Y., Wang, Z., & Patel, S. A. (2025) · Cancer Medicine · doi:10.1002/cam4.70624 · Cited by 1
Can De-Escalation of Adjuvant Therapy Be Considered for Older Adults with Breast Cancer?
Chadha, M., White, J. R., & Jagsi, R. (2025) · NEJM Evidence · doi:10.1056/evidtt2300358 · Cited by 1
Recent advancements in personalized management of prostate cancer biochemical recurrence after radical prostatectomy
Falkenbach, F., Ekrutt, J., & Maurer, T. (2025) · Current Opinion in Urology · doi:10.1097/mou.0000000000001305 · Cited by 1
The Surgical Imprint: How Operative Trauma May Shape Radiation Tolerance After Prostatectomy
MORGANTI, A. G., Macchia, G., Mammini, F., Zamfir, A. A., Buwenge, M., Cellini, F., Bianchi, L., Schiavina, R., Brunocilla, E., Deodato, F., et al. (2025) · Cancers · doi:10.3390/cancers17162685 · Cited by 1
“Studies such as GETUG-AFU 16 [30] and RTOG 9601 [31] suggest that short-term ADT improves cancer control in salvage RT but does not significantly impact acute toxicity.”
Quality of life is not compromised with intensification of androgen therapy in recurrent prostate cancer
Seymour, Z., & Hamstra, D. A. (2018) · The Lancet Oncology · doi:10.1016/s1470-2045(18)30567-9 · Cited by 1
Behandlung des fortgeschrittenen Prostatakarzinoms – eine interdisziplinäre Empfehlung
Omlin, A. G., Spahn, M., Beyer, J., Eberli, D., Gillessen, S., Jochum, W., Kueng, M., Nitzsche, E. U., Rentsch, C. A., Roggero, E., et al. (2018) · Praxis · doi:10.1024/1661-8157/a003054 · Cited by 1
Changes in prostate-specific antigen midway through salvage radiotherapy may be associated with long-term outcomes
Homza, J. M., Nawrocki, J. T., Brereton, H. D., & Peters, C. A. (2019) · Journal of Radiation Oncology · doi:10.1007/s13566-019-00383-1 · Cited by 1
Seeking Consistency in Guidelines: Level of Evidence, Trial Endpoints, and Personalized Recommendations
Spratt, D. E. (2019) · Practical Radiation Oncology · doi:10.1016/j.prro.2019.06.006 · Cited by 1
Optimisation du contrôle local des cancers de la prostate à haut risque par les traitements multimodaux
Latorzeff, I. (2019) · The French Journal of Urology · doi:10.1016/s1166-7087(19)30166-6 · Cited by 1
Complications des traitements multimodaux
Hennequin, C. (2019) · The French Journal of Urology · doi:10.1016/s1166-7087(19)30168-x · Cited by 1
Post-operative salvage androgen deprivation and radiotherapy for prostate cancer
D'Amico, A. V. (2019) · The Lancet Oncology · doi:10.1016/s1470-2045(19)30488-7 · Cited by 1
Genomic Strategies to Personalize Use of Androgen Deprivation Therapy With Radiotherapy
Glicksman, R., & Berlín, A. (2020) · The Cancer Journal · doi:10.1097/ppo.0000000000000419 · Cited by 1
Clinically Lymph Node Positive Prostate Cancer: At the Intersection of Focal and Systemic Disease Control
Reichert, Z. R., & Dess, R. T. (2020) · The Cancer Journal · doi:10.1097/ppo.0000000000000421 · Cited by 1
Current Approach in Radiation Therapy for Prostate Cancer
Çetin, İ. A. (2020) · Bulletin of Urooncology · doi:10.4274/uob.galenos.2019.1418 · Cited by 1
Recovery From Bicalutamide-Associated Pneumonitis in a Patient With ATM-Deficient Prostate Cancer
Smith, T. J., & Antonarakis, E. S. (2020) · JCO Oncology Practice · doi:10.1200/op.20.00219 · Cited by 1
Prognostic Risk Classification for Biochemical Relapse-Free Survival in Oligometastatic Recurrent Prostate Cancer Determined by Choline PET
Gravis, G., Autret, A., Guibert-Broudic, M., Dubergé, T., Zemmour, C., Carrier, P., Salem, N., Badinand, D., Cartier, L., Gross, E., et al. (2021) · Clinical Genitourinary Cancer · doi:10.1016/j.clgc.2021.03.004 · Cited by 1
“The RTOG 9601 and GETUG-AFU 16 two large randomized trials of salvage radiotherapy post prostatectomy (evaluated with standard imaging), have shown improvement with the addition of ADT to salvage radiotherapy over radiotherapy alone 17 18 .”
Method
Twelve-year outcomes of prostate cancer after radical prostatectomy for T3 and/or positive margins managed with surveillance or salvage radiation therapy, based on risk groups
Goy, B. W., & Liu, I. A. (2021) · Prostate International · doi:10.1016/j.prnil.2021.05.002 · Cited by 1
“001 Median number of LN's (range) 5 (1-21) 5 (1-33) 5 (1-41) 5 (1-27) 0.”
Functional and mutational analysis after radiation and cetuximab treatment on prostate carcinoma cell line DU145
Schneider, R., Gademann, G., Ochel, H.-J., Neumann, K., Jandrig, B., Hass, P., Walke, M., Schostak, M., Brunner, T. B., & Christoph, F. (2021) · Radiation Oncology · doi:10.1186/s13014-021-01859-6 · Cited by 1
“Radiated patients with higher risk for recurrence opt for adjuvant hormone ablation therapy with a Gonadotropin-Releasing-Hormon blocker [4].”
Background
Par-4 Secretagogues in Clinical Trials
Wang, P., & Hao, Z. (2021) · Springer eBooks · doi:10.1007/978-3-030-80558-6_20 · Cited by 1
Nomograms for Metastasis-Free and Overall Survival for Pathologically Node Positive Prostate Cancer Patients Treated With or Without Radiation Therapy Plus Short-Term ADT
Hutten, R. J., & Tward, J. D. (2022) · Clinical Genitourinary Cancer · doi:10.1016/j.clgc.2022.01.018 · Cited by 1
Evaluation of Patients for Radiotherapy for Prostate Adenocarcinoma
Wallach, J. B., Stern, C., Karp, M., & Schwartz, D. L. (2023) · IntechOpen eBooks · doi:10.5772/intechopen.109447 · Cited by 1
Postprostatectomy radiation therapy for biochemically recurrent prostate cancer
Schloss, M. G., Peddada, S., Bakhshi, A., Phelps, A., Velayati, A., & Adkison, J. B. (2018) · Applied Radiation Oncology · doi:10.37549/aro1170 · Cited by 1
Re: Radiation With or Without Antiandrogen Therapy in Recurrent Prostate Cancer
Lamb, B. W., Violet, J. A., Siva, S., & Murphy, D. G. (2017) · European Urology · doi:10.1016/j.eururo.2017.03.014 · Cited by 1
“They also showed that the greatest benefit was achieved in patients with aggressive disease [1].”
Background

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 › 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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Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer

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