, which is diagnosed in approximately
500,000 men annually in the United States, shows
an increasing incidence with age and is character-
ized by low serum T and symptoms including loss of
libido, erectile dysfunction, depression, lethargy,
concentration difFculties, sleep disturbances, osteo-
porosis and loss of muscle mass.
these symptoms in most men. Hypogonadism most
commonly affects middle-aged or older men, a pop-
ulation that is also frequently affected by CaP.
Thus, these conditions often coexist, especially as
RT for CaP is associated with lower serum T.
indicated in men with CaP due to concern that
higher serum T would enhance CaP growth.
Recent clinical experiences have suggested that
TTh is not as risky as once believed in men with
CaP. In multiple series in which TTh was offered to
men following RP 4 CaP recurrences were observed
among 177 cases.
However, the safety of TTh in
men after RT for CaP is more uncertain, in part due
to the small number of reported cases. ±urthermore,
TTh in men with CaP following RT may appear
more risky than after RP, in part due to the chance
of residual CaP after RT, the unknown status of
lymph nodes or surgical margins and absent pa-
thology data on the entire prostate gland. However,
several small studies in a total of 69 patients with
CaP treated with TTh following brachytherapy and/
or EBRT have revealed transient increases in PSA
but no CaP recurrence or progression.
tion, in men with CaP on active surveillance no
signiFcant increases in PSA or CaP progression
have been observed.
We present our multi-institutional experience of
the effects of TTh on longitudinal CaP outcomes in
hypogonadal men after RT.
MATERIALS AND METHODS
Patient Identifcation and Data Acquisition
We retrospectively reviewed the records of men with
hypogonadism treated with TTh after RT for CaP at a
total of 4 institutions, including Baylor College of Medi-
cine, Men’s Health Boston, University of South ±lorida,
and South Texas Urology and Urologic Oncology. Insti-
tutional review board approval was obtained from all
participating institutions and data sharing agreements
were put in place. RT encompassed EBRT and brachy-
therapy with men in the cohort undergoing EBRT and/or
brachytherapy. Patients underwent RT for CaP from 1994
to 2012 and received TTh between 1999 and 2013. Men
were diagnosed with hypogonadism by hypogonadal
symptoms, including low libido, erectile dysfunction and
fatigue, as well as by biochemical Fndings, including
serum T 350 ng/dl or less, and/or ±T less than 1.5 ng/dl or
calculated ±T less than 100 pg/ml. Patients received TTh
via gel, injection or subcutaneously implanted pellets.
Baseline serum T, ±T, estradiol, sex-hormone binding
globulin and PSA were determined before TTh initiation.
±ollowup serum hormone values were evaluated every
3 to 6 months thereafter. All followup serum values
presented correspond to the most recent value available.
±ollowup represents the time from initial presentation
through the most recent followup. Laboratory testing was
performed at the Laboratory for Male Reproductive
Research and Testing, Baylor College of Medicine (LIL
and MK); Tosoh Bioscience, San ±rancisco, California
(AM); LabCorp, Burlington, North Carolina (M±S); or
Quest Diagnostics, Madison, New Jersey (AM and RC).
Men were grouped into risk subgroups, including
Gl 6 or less, intermediate
4 and 4
Gl 8 or greater. BCR was deemed to have occurred
if any of certain conditions were met, including 1) PSA
greater than absolute nadir plus 2 ng/ml, 2) PSA greater
than current nadir plus 3 ng/ml or 3) 2 consecutive in-
creases in PSA of 0.5 ng/ml or greater.
was deFned as the lowest PSA before the elevated PSA
concerning for BCR. Absolute nadir referred to the lowest
PSA during followup.
Baseline and followup serum values were compared using
the Wilcoxon signed rank test. PSAV was calculated by
linear regression using at least 3 PSA values during
12 months or greater. PSAV was compared across sub-
groups with the Kruskal-Wallis and ±isher exact tests. All
analyses were performed using SPSS
, version 21 with
0.05 considered signiFcant.
We identiFed 98 hypogonadal men with a history of
CaP who underwent RT and were subsequently
started on TTh (supplementary table 1, http://
). Median age was 70.0 years (range
34 to 85). Of the men 50 (51%) received ADT in
addition to RT for initial CaP management while
the remainder received RT alone. The interval be-
tween ADT cessation and TTh initiation was 5 to
60 months. No individual was receiving ADT at the
time of TTh initiation.
Initial prostate biopsy data were available on 86
44 (44.9%) with Gl 6, 28 (28.6%) with Gl 7, 7 (7.1%)
with Gl 8 and 4 (4.1%) with Gl 9 disease. TTh was
started a median of 28.6 months (range 13.8 to 40.4)
after RT. The mode of TTh was gels in 65%, in-
jections in 24% and pellets in 11%. The median time
from TTh initiation to the most recent followup visit
was 40.8 months (range 1.5 to 147).
Table 1 lists baseline and followup results. Median
serum T increased from 209 to 420 ng/dl (p
and median free T increased from 5.9 to 10.7 pg/ml
0.001) at followup. Median serum PSA was 0.08
ng/ml at baseline and 0.09 ng/ml at followup
0.05). Serum estradiol and sex-hormone binding
globulin did not change signiFcantly.
TESTOSTERONE THERAPY AFTER RADIATION THERAPY FOR PROSTATE CANCER