Adjuvant Radiotherapy for Pathological T3N0M0 Prostate Cancer Significantly Reduces Risk of Metastases and Improves Survival

Long-Term Followup of a Randomized Clinical Trial

Thompson, Ian M.
Tangen, Catherine M.
Paradelo, Jorge
Lucia, Scott M.
Miller, Gary
Troyer, Dean
Messing, Edward
Forman, Jeffrey
Chin, Joseph
Swanson, Gregory
Canby-Hagino, Edith
Crawford, David E.

^aUniversity of Texas Health Science Center at San Antonio, San Antonio, Texas
^bWilford Hall Medical Center, San Antonio, Texas
^cThe Fred Hutchinson Cancer Research Center, Seattle, Washington
^dThe Kansas City Community Clinical Oncology Program, Kansas City, Missouri
^eThe University of Colorado Health Science Center, Denver, Colorado
^fThe James P. Wilmot Cancer Center, University of Rochester School of Medicine, Rochester, New York
^gWayne State University School of Medicine, Detroit, Michigan
^hUniversity of Western Ontario, Department of Surgical Oncology, London, Ontario

Submitted for publication September 15, 2008

Study received approval from individual institutional review boards of the participating institutions.

Supported by Public Health Service Cooperative Agreement grants awarded by the National Cancer Institute, Department of Health and Human Services: CA38926, CA32102, CA14028, CA58416, CA58658, CA42777, CA27057, CA46136, CA35431, CA58882, CA12644, CA58861, CA35090, CA37981, CA76429, CA04919, CA76132, CA35119, CA35178, CA35176, CA46282, CA67575, CA45377, CA46113, CA74647, CA35261, CA049020, CA20319, CA76447, CA58723, CA12213, CA22433, CA46441, and by the National Cancer Institute of Canada Grant PR-2.

^*Correspondence: Department of Urology, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, Texas 78229 (telephone: 210-567-5643; FAX: 210-567-6868; e-mail: [email protected])

^†Financial interest and/or other relationship with Veridex, Mission and AstraZeneca.

^‡Deceased.

Journal of Urology 181(3):p 956-962, March 2009.

Purpose:

Extraprostatic disease will be manifest in a third of men after radical prostatectomy. We present the long-term followup of a randomized clinical trial of radiotherapy to reduce the risk of subsequent metastatic disease and death.

Materials and Methods:

A total of 431 men with pT3N0M0 prostate cancer were randomized to 60 to 64 Gy adjuvant radiotherapy or observation. The primary study end point was metastasis-free survival.

Results:

Of 425 eligible men 211 were randomized to observation and 214 to adjuvant radiation. Of those men under observation 70 ultimately received radiotherapy. Metastasis-free survival was significantly greater with radiotherapy (93 of 214 events on the radiotherapy arm vs 114 of 211 events on observation; HR 0.71; 95% CI 0.54, 0.94; p = 0.016). Survival improved significantly with adjuvant radiation (88 deaths of 214 on the radiotherapy arm vs 110 deaths of 211 on observation; HR 0.72; 95% CI 0.55, 0.96; p = 0.023).

Conclusions:

Adjuvant radiotherapy after radical prostatectomy for a man with pT3N0M0 prostate cancer significantly reduces the risk of metastasis and increases survival.