This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (256)  • Contact me when this article is cited  Related Content  • Related letters  • Related article  • Similar articles in JAMA  Topic Collections  • Men's Health  • Prostate Disease  • Oncology  • Prostate Cancer  • Radiation Therapy  • Randomized Controlled Trial  • Alert me on articles by topic  Social Bookmarking   What's this?

A Randomized Controlled Trial

Anthony V. D'Amico, MD, PhD; Judith Manola, MS; Marian Loffredo, RN, OCN; Andrew A. Renshaw, MD; Alyssa DellaCroce, BA; Philip W. Kantoff, MD

JAMA. 2004;292:821-827.

Context  Survival benefit in the management of high-grade clinically localized prostate cancer has been shown for 70 Gy radiation therapy combined with 3 years of androgen suppression therapy (AST), but long-term AST is associated with many adverse events.

Objective  To assess the survival benefit of 3-dimensional conformal radiation therapy (3D-CRT) alone or in combination with 6 months of AST in patients with clinically localized prostate cancer.

Design, Setting, and Patients  A prospective randomized controlled trial of 206 patients with clinically localized prostate cancer who were randomized to receive 70 Gy 3D-CRT alone (n = 104) or in combination with 6 months of AST (n = 102) from December 1, 1995, to April 15, 2001. Eligible patients included those with a prostate-specific antigen (PSA) of at least 10 ng/mL, a Gleason score of at least 7, or radiographic evidence of extraprostatic disease.

Main Outcome Measures  Time to PSA failure (PSA >1.0 ng/mL and increasing >0.2 ng/mL on 2 consecutive visits) and overall survival.

Results  After a median follow-up of 4.52 years, patients randomized to receive 3D-CRT plus AST had a significantly higher survival (P = .04), lower prostate cancer–specific mortality (P = .02), and higher survival free of salvage AST (P = .002). Kaplan-Meier estimates of 5-year survival rates were 88% (95% confidence interval [CI], 80%-95%) in the 3D-CRT plus AST group vs 78% (95% CI, 68%-88%) in the 3D-CRT group. Rates of survival free of salvage AST at 5 years were 82% (95% CI, 73%-90%) in the 3D-CRT plus AST group vs 57% (95% CI, 46%-69%) in the 3D-CRT group.

Conclusion  The addition of 6 months of AST to 70 Gy 3D-CRT confers an overall survival benefit for patients with clinically localized prostate cancer.

Author Affiliations: Departments of Radiation Oncology (Dr D'Amico and Ms Loffredo), Biostatistics (Mss Manola and DellaCroce), Pathology (Dr Renshaw), and Medical Oncology (Dr Kantoff), Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, Mass.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED LETTERS

Androgen Suppression Plus Radiation Therapy for Prostate Cancer
Carl D. Atkins
JAMA. 2004;292(17):2084.
EXTRACT | FULL TEXT  

Androgen Suppression Plus Radiation Therapy for Prostate Cancer
Eric M. Horwitz, Steven J. Feigenberg, Alan Pollack, Gerald E. Hanks, and Robert G. Uzzo
JAMA. 2004;292(17):2084-2085.
EXTRACT | FULL TEXT  

Androgen Suppression Plus Radiation Therapy for Prostate Cancer—Reply
Anthony V. D’Amico, Marian Loffredo, Judith Manola, Alyssa DellaCroce, Andrew A. Renshaw, and Philip W. Kantoff
JAMA. 2004;292(17):2085.
EXTRACT | FULL TEXT  

Androgen Suppression Plus Radiation for Prostate Cancer
Jeremy Millar
JAMA. 2004;292(21):2581-2582.
EXTRACT | FULL TEXT  

Androgen Suppression Plus Radiation for Prostate Cancer—Reply
Anthony V. D’Amico
JAMA. 2004;292(21):2582.
EXTRACT | FULL TEXT  

RELATED ARTICLE

Radiation Therapy and Androgen Suppression as Treatment for Clinically Localized Prostate Cancer: The New Standard?
Theodore L. DeWeese
JAMA. 2004;292(7):864-866.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Selection Bias Is Not a Good Reason for Advising More Than 5 Years of Adjuvant Hormonal Therapy for All Patients With Locally Advanced Prostate Cancer Treated With Radiotherapy
Collette and Studer
JCO 2009;27:e201-e202.
FULL TEXT  

Early PSA decrease is an independent predictive factor of clinical failure and specific survival in patients with localized prostate cancer treated by radiotherapy with or without androgen deprivation therapy
de Crevoisier et al.
Ann Oncol 2009;0:mdp365v1-mdp365.
ABSTRACT | FULL TEXT  

Review: Risk stratification in the hormonal treatment of patients with prostate cancer
Uhlman et al.
Therapeutic Advances in Medical Oncology 2009;1:79-94.
ABSTRACT  

Hormonal Therapy Use for Prostate Cancer and Mortality in Men With Coronary Artery Disease-Induced Congestive Heart Failure or Myocardial Infarction
Nanda et al.
JAMA 2009;302:866-873.
ABSTRACT | FULL TEXT  

Risk of Death From Prostate Cancer After Brachytherapy Alone or With Radiation, Androgen Suppression Therapy, or Both in Men With High-Risk Disease
D'Amico et al.
JCO 2009;27:3923-3928.
ABSTRACT | FULL TEXT  

A 64-Year-Old Man With Low-Risk Prostate Cancer: Review of Prostate Cancer Treatment
Sanda and Kaplan
JAMA 2009;301:2141-2151.
ABSTRACT | FULL TEXT  

Impact of the Duration of Adjuvant Hormonal Therapy in Patients With Locally Advanced Prostate Cancer Treated With Radiotherapy: A Secondary Analysis of RTOG 85-31
Souhami et al.
JCO 2009;27:2137-2143.
ABSTRACT | FULL TEXT  

Prostate cancer: ESMO Clinical Recommendations for diagnosis, treatment and follow-up
Horwich et al.
Ann Oncol 2009;20:iv76-iv78.
FULL TEXT  

Cardiovascular Mortality After Androgen Deprivation Therapy for Locally Advanced Prostate Cancer: RTOG 85-31
Efstathiou et al.
JCO 2009;27:92-99.
ABSTRACT | FULL TEXT  

National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for Use of Tumor Markers in Testicular, Prostate, Colorectal, Breast, and Ovarian Cancers
Sturgeon et al.
Clin. Chem. 2008;54:e11-e79.
ABSTRACT | FULL TEXT  

Quality of Life and Satisfaction with Outcome among Prostate-Cancer Survivors
Yu et al.
NEJM 2008;359:200-202.
FULL TEXT  

Survival Following Primary Androgen Deprivation Therapy Among Men With Localized Prostate Cancer
Lu-Yao et al.
JAMA 2008;300:173-181.
ABSTRACT | FULL TEXT  

Risk of Prostate Cancer Recurrence in Men Treated With Radiation Alone or in Conjunction With Combined or Less Than Combined Androgen Suppression Therapy
D'Amico et al.
JCO 2008;26:2979-2983.
ABSTRACT | FULL TEXT  

Quality of Life and Satisfaction with Outcome among Prostate-Cancer Survivors
Sanda et al.
NEJM 2008;358:1250-1261.
ABSTRACT | FULL TEXT  

Systematic Review: Comparative Effectiveness and Harms of Treatments for Clinically Localized Prostate Cancer
Wilt et al.
ANN INTERN MED 2008;148:435-448.
ABSTRACT | FULL TEXT  

Short-Term Neoadjuvant Androgen Deprivation Therapy and External-Beam Radiotherapy for Locally Advanced Prostate Cancer: Long-Term Results of RTOG 8610
Roach et al.
JCO 2008;26:585-591.
ABSTRACT | FULL TEXT  

Androgen Suppression and Radiation vs Radiation Alone for Prostate Cancer: A Randomized Trial
D'Amico et al.
JAMA 2008;299:289-295.
ABSTRACT | FULL TEXT  

Aspirin and Hormone Therapy for Prostate Cancer
D'Amico et al.
NEJM 2007;357:2737-2738.
FULL TEXT  

Survival in Men With Nonmetastatic Prostate Cancer Treated With Hormone Therapy: A Quantitative Systematic Review
Antonarakis et al.
JCO 2007;25:4998-5008.
ABSTRACT | FULL TEXT  

The role of Src in prostate cancer
Fizazi
Ann Oncol 2007;18:1765-1773.
ABSTRACT | FULL TEXT  

Androgen Deprivation Therapy for Localized Prostate Cancer and the Risk of Cardiovascular Mortality
Tsai et al.
JNCI J Natl Cancer Inst 2007;99:1516-1524.
ABSTRACT | FULL TEXT  

PSA Failure Following Definitive Treatment of Prostate Cancer Having Biopsy Gleason Score 7 With Tertiary Grade 5
Patel et al.
JAMA 2007;298:1533-1538.
ABSTRACT | FULL TEXT  

Influence of Androgen Suppression Therapy for Prostate Cancer on the Frequency and Timing of Fatal Myocardial Infarctions
D'Amico et al.
JCO 2007;25:2420-2425.
ABSTRACT | FULL TEXT  

Predicting the Outcome of Salvage Radiation Therapy for Recurrent Prostate Cancer After Radical Prostatectomy
Stephenson et al.
JCO 2007;25:2035-2041.
ABSTRACT | FULL TEXT  

Early versus delayed endocrine therapy for prostate cancer
Schroder
Endocr Relat Cancer 2007;14:1-11.
ABSTRACT | FULL TEXT  

Prostate Cancer: A Practical Approach to Current Management of Recurrent Disease
Walczak and Carducci
Mayo Clin Proc. 2007;82:243-249.
ABSTRACT | FULL TEXT  

Toward the Optimal Use of Androgen Suppression Therapy in the Radiotherapeutic Management of Prostate Cancer
D'Amico
JCO 2007;25:8-9.
FULL TEXT  

Phase II Study of Neoadjuvant Androgen Deprivation Followed by External-Beam Radiotherapy With 9 Months of Androgen Deprivation for Intermediate- to High-Risk Localized Prostate Cancer
Heymann et al.
JCO 2007;25:77-84.
ABSTRACT | FULL TEXT  

External-beam radiotherapy for localized prostate cancer.
Pisansky
NEJM 2006;355:1583-1591.
FULL TEXT  

Androgen Induction of Prostate Cancer Cell Invasion Is Mediated by Ezrin
Chuan et al.
J. Biol. Chem. 2006;281:29938-29948.
ABSTRACT | FULL TEXT  

Six-Month Androgen Suppression Plus Radiation Therapy Compared With Radiation Therapy Alone for Men With Prostate Cancer and a Rapidly Increasing Pretreatment Prostate-Specific Antigen Level
D'Amico et al.
JCO 2006;24:4190-4195.
ABSTRACT | FULL TEXT  

Timing of androgen deprivation therapy: some questions answered, others not.
Schellhammer
JNCI J Natl Cancer Inst 2006;98:802-803.
FULL TEXT  

Risk of the "androgen deprivation syndrome" in men receiving androgen deprivation for prostate cancer.
Shahinian et al.
Arch Intern Med 2006;166:465-471.
ABSTRACT | FULL TEXT  

Theme Issue on Men's Health: Call for Papers
Fontanarosa and Cole
JAMA 2006;295:440-441.
FULL TEXT  

Radiotherapy in the Management of Clinically Localized Prostate Cancer: Evolving Standards, Consensus, Controversies and New Directions
Speight and Roach
JCO 2005;23:8176-8185.
ABSTRACT | FULL TEXT  

Early Versus Delayed Androgen Deprivation for Prostate Cancer: New Fuel for an Old Debate
Ryan and Small
JCO 2005;23:8225-8231.
ABSTRACT | FULL TEXT  

Is dehydroepiandrosterone a hormone?
Labrie et al.
J Endocrinol 2005;187:169-196.
ABSTRACT | FULL TEXT  

Long-term Outcomes of 60 Gy Conventional Radiotherapy Combined with Androgen Deprivation for Localized or Locally Advanced Prostate Cancer
Hashine et al.
Jpn J Clin Oncol 2005;35:655-659.
ABSTRACT | FULL TEXT  

When Prostate Brachytherapy Fails: A Case Report and Discussion
Kadoch et al.
The Oncologist 2005;10:799-805.
ABSTRACT | FULL TEXT  

Risk-Adapted Androgen Deprivation and Escalated Three-Dimensional Conformal Radiotherapy for Prostate Cancer: Does Radiation Dose Influence Outcome of Patients Treated With Adjuvant Androgen Deprivation? A GICOR Study
Zapatero et al.
JCO 2005;23:6561-6568.
ABSTRACT | FULL TEXT  

Radiation Dose Escalation as Treatment for Clinically Localized Prostate Cancer: Is More Really Better?
DeWeese and Song
JAMA 2005;294:1274-1276.
FULL TEXT  

Pretreatment PSA Velocity and Risk of Death From Prostate Cancer Following External Beam Radiation Therapy
D'Amico et al.
JAMA 2005;294:440-447.
ABSTRACT | FULL TEXT  

Androgen Deprivation Therapy for Prostate Cancer
Sharifi et al.
JAMA 2005;294:238-244.
ABSTRACT | FULL TEXT  

Gonadotropin-Releasing Hormone Agonists in the Treatment of Prostate Cancer
Labrie et al.
Endocr. Rev. 2005;26:361-379.
ABSTRACT | FULL TEXT  

Androgen Suppression Plus Radiation for Prostate Cancer
Millar
JAMA 2004;292:2581-2582.
FULL TEXT  

Androgen Suppression Plus Radiation Therapy for Prostate Cancer
Atkins
JAMA 2004;292:2084-2084.
FULL TEXT  

Androgen Suppression Plus Radiation Therapy for Prostate Cancer
Horwitz et al.
JAMA 2004;292:2084-2085.
FULL TEXT  

Management of localised prostate cancer
DTB 2004;42:81-85.
ABSTRACT | FULL TEXT  

Radiation Therapy and Androgen Suppression as Treatment for Clinically Localized Prostate Cancer: The New Standard?
DeWeese
JAMA 2004;292:864-866.
FULL TEXT