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[7] Hu¨ sch T, Kretschmer A, Thomsen et al. Risk factors for failure of
male slings and artificial urinary sphincters: results from a large
Middle European cohort study. Urol Int. In press.
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Emilio Riosa,* , Luis Martinez-Pin˜eirob
aUrology Unit, Hospital Universitario Infanta Sofia, Madrid, Spain
bUrology Unit, Hospital Universitario La Paz, Madrid, Spain
*Corresponding author. Urology Unit, Hospital Universitario Infanta
Sofia, Avda de Europa 34, San Sebastian de los Reyes.
Madrid 28702, Spain.
E-mail address: (E. Rios).
# 2017 European Association of Urology.
Published by Elsevier B.V. All rights reserved.
Re: Radiation With or Without Antiandrogen Therapy in
Recurrent Prostate Cancer
Shipley WU, Seiferheld W, Lukka HR, et al
N Engl J Med 2017;376:417–28
Experts’ summary:
The authors conducted a double-blind, placebo-controlled
trial of 24 mo of bicalutamide in addition to 64.8 Gy salvage
radiation therapy (SRT) of the prostate bed in patients with
prostate-specific antigen (PSA) recurrence after radical pros-
tatectomy (RTOG 9601). Between 1998 and 2003, a total of
760 eligible patients were enrolled; the primary endpoint was
overall survival.
Notably, 90 [1_TD$DIFF]patients (11.8%) had a PSA nadir after surgery
of 0.5 ng/ml. While 405 patients (53.3%) had a PSA level at
trial entry of <0.7 ng/ml, the PSA level at trial entry was 0.7–
1.5 ng/ml in 237 patients (31.2%) and >1.5–4.0 ng/ml in
118 patients (15.5%).
The 12-yr overall survival rate was significantly im-
proved by addition of bicalutamide (76.3% vs 71.3%; hazard
ratio [HR] 0.77, 95% confidence interval [CI] 0.59–0.99;
p = 0.04). Furthermore, the cumulative incidence of meta-
static prostate cancer was significantly reduced (14.5% vs
23.0%; HR 0.63, 95% CI 0.46–0.87; p = 0.005). However,
subgroup analyses revealed that for patients with a PSA
level at trial entry of <0.7 ng/ml, bicalutamide was not
superior to placebo in terms of 12-yr overall survival
(p = 0.53) or distant metastasis (p = 0.26).
Experts’ comments:
The RTOG 9601 trial provides evidence that bicalutamide
added to SRT improves overall survival in patients with PSA
0.7 ng/ml. However, these patients, together with the 11.8%
of patients who had a PSA nadir after surgery of 0.5 ng/ml,
probably harbored micrometastatic disease, which is likely to
be the reason for the increase in overall survival.
There is growing evidence that SRT should be applied
early, preferably for PSA levels <0.2 ng/ml [1]. The use of
bicalutamide appears not to be beneficial in more ‘‘early
salvage’’ patients (eg, PSA <0.7 ng/ml). The GETUG-16 trial
randomized 743 men, 80% of whom had PSA of <0.5 ng/ml,
to 66 Gy SRT alone versus SRT combined with 6 mo of a
luteinizing hormone–releasing hormone agonist and
revealed no overall survival benefit after combined
treatment [2].
Dose-intensified SRT appears to be beneficial and well
tolerated [1,3] and early dose-intensified SRT alone may be
a better option for patients with a recurrent PSA level of
<0.7 ng/ml. Genomic testing may further guide identifica-
tion of patients who might benefit from androgen depriva-
tion therapy or other additional treatments [4]. Metformin
(as being investigated in the SAKK 08/15 PROMET trial;
Clinicaltrials.gov NCT02945813) or regional hyperthermia
[5] may be effective and less toxic strategies for improving
the effectiveness of early SRT.
Conflicts of interest: The authors have nothing to disclose.
References
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[2]
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[3]
[4]
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[5]
Marcus Becka, Stefanie Hayozb, Pirus Ghadjara,*
aCharite´ Universita¨tsmedizin Berlin, Berlin, Germany
bSAKK Coordinating Center, Bern, Switzerland
*Corresponding author. Charite´ Universita¨tsmedizin Berlin,
Augustenburger Platz 1, 13353 Berlin, Germany.
E-mail address: (P. Ghadjar).
# 2017 European Association of Urology.
Published by Elsevier B.V. All rights reserved.
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