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.
OBJECTIVE
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.


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).


CONCLUSIONS
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.
Department of Urology, University of Bern, Inselspital, CH-3010 Bern, Switzerland. urs.studer@insel.ch
Urs E
UE
Studer
Dieter
D
Hauri
Silvia
S
Hanselmann
Dominique
D
Chollet
Hans-Jürg
HJ
Leisinger
Thomas
T
Gasser
Edgar
E
Senn
Felix B
FB
Trinkler
Reto M
RM
Tscholl
George N
GN
Thalmann
Daniel
D
Dietrich
D000368:Aged; D018450:Disease Progression; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009919:Orchiectomy; D011379:Prognosis; D011471:Prostatic Neoplasms / Q000150:complications / Q000401:mortality / Q000601:surgery*; D015996:Survival Rate; D013997:Time Factors