Journal of Clinical Oncology, Vol 22, No 20 (October 15), 2004: pp. 4109-4118
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.11.514
Immediate Versus Deferred Hormonal Treatment for Patients With Prostate Cancer Who Are Not Suitable for Curative Local Treatment: Results of the Randomized Trial SAKK 08/88
Urs E. Studer,
Dieter Hauri,
Silvia Hanselmann,
Dominique Chollet,
Hans-Jürg Leisinger,
Thomas Gasser,
Edgar Senn,
Felix B. Trinkler,
Reto M. Tscholl,
George N. Thalmann,
Daniel Dietrich
From the Swiss Group for Clinical Cancer Research (SAKK), and the Department of Urology, University of Bern, Bern, Switzerland
Address reprint requests to Urs E. Studer, MD, Department of Urology, University of Bern, Inselspital, CH-3010 Bern, Switzerland; e-mail: urs.studer{at}insel.ch
PURPOSE: To determine if immediate hormonal therapy is advantageous compared with deferred treatment in newly diagnosed asymptomatic prostate cancer patients who, for any reason, were not candidates for curative local treatment.
PATIENTS AND METHODS: Between February 1988 and February 1992, 197 patients with a median age of 76 years (range, 56 to 86 years) were randomly assigned to receive either immediate or deferred orchiectomy on symptomatic progression. The two groups did not differ significantly in clinical or laboratory parameters; 67% had T3-4 tumors and 20% had lymph node metastases. Patient accrual was stopped prematurely because of a similar competing trial. Therefore, observation time was prolonged to achieve the desired number of events and statistical power.
RESULTS: Deferred orchiectomy was necessary in 58% of the patients. Median time to disease progression was 2.8 years less than for patients with immediate orchiectomy. However, overall pain-free time from random assignment to symptomatic progression after immediate or deferred orchiectomy, and performance status, were identical in both groups. Cancer-specific survival tended to be longer in the immediate group (P = .09) but there was no difference in overall survival between the two groups (P = .96). The median hemoglobin value decreased significantly after immediate orchiectomy (P < .001).
CONCLUSION: For elderly, asymptomatic patients not undergoing curative local treatment, we were unable to show any major advantage of immediate compared with deferred hormonal treatment regarding quality of life or overall survival in our limited number of patients. Disabling complications were prevented in the deferred-treatment arm by careful follow-up; 42% of these patients never required any tumor-specific treatment.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
This article has been cited by other articles:

|
 |

|
 |
 
G. L. Lu-Yao, P. C. Albertsen, D. F. Moore, W. Shih, Y. Lin, R. S. DiPaola, and S.-L. Yao
Survival Following Primary Androgen Deprivation Therapy Among Men With Localized Prostate Cancer
JAMA,
July 9, 2008;
300(2):
173 - 181.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. A. Loblaw, K. S. Virgo, R. Nam, M. R. Somerfield, E. Ben-Josef, D. S. Mendelson, R. Middleton, S. A. Sharp, T. J. Smith, J. Talcott, et al.
Initial Hormonal Management of Androgen-Sensitive Metastatic, Recurrent, or Progressive Prostate Cancer: 2007 Update of an American Society of Clinical Oncology Practice Guideline
J. Clin. Oncol.,
April 20, 2007;
25(12):
1596 - 1605.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G. M. Duchesne, R. Syme, and D. Howell
How Early Is Early: Androgen Deprivation for Prostate-Specific Antigen Relapse in Prostate Cancer
J. Clin. Oncol.,
June 20, 2006;
24(18):
2964 - 2964.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. J. Ryan
In Reply
J. Clin. Oncol.,
June 20, 2006;
24(18):
2965 - 2965.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
U. E. Studer, P. Whelan, W. Albrecht, J. Casselman, T. de Reijke, D. Hauri, W. Loidl, S. Isorna, S. K. Sundaram, M. Debois, et al.
Immediate or Deferred Androgen Deprivation for Patients With Prostate Cancer Not Suitable for Local Treatment With Curative Intent: European Organisation for Research and Treatment of Cancer (EORTC) Trial 30891
J. Clin. Oncol.,
April 20, 2006;
24(12):
1868 - 1876.
[Abstract]
[Full Text]
[PDF]
|
 |
|
|