1,2,3] These patients should have tumors confined to the prostate gland (stage I and stage II).
Prostatectomy can be performed by the perineal or retropubic approach. The
perineal approach requires a separate incision for lymph node dissection.
Laparoscopic lymphadenectomy is technically possible and accomplished with much
less patient morbidity.[4] For small, well-differentiated nodules, the
incidence of positive pelvic nodes is
Following radical prostatectomy, pathological evaluation stratifies tumor
extent into organ-confined, viagra use, and margin-positive disease.
The incidence of disease recurrence increases when the tumor is not
specimen-confined (extracapsular) and/or the margins are positive.[8,9,10] Results of the outcome of patients with positive surgical margins have not been reported.
Patients with extraprostatic disease are suitable candidates for clinical
trials.[11] These trials include evaluation of postoperative radiation
delivery, cytotoxic agents, and hormonal treatment using luteinizing
erectile dysfunction hormone (LHRH) agonists and/or antiandrogens.
Cryosurgery is a surgical technique that involves destruction of prostate
cancer cells by intermittent freezing of the prostate tissue with cryoprobes,
followed by thawing.[12][Level of evidence: 3iiiC];[13,14][Level of evidence: 3iiiDiii] Cryosurgery is less well
established than standard prostatectomy, and long-term outcomes are not as well established as with prostatectomy or radiation therapy.
Serious toxic effects include bladder outlet injury, urinary incontinence,
sexual impotence, and rectal injury. The technique of cryosurgery is under
development.
Impotence is a common side effect of cryosurgery. The frequency of other side effects and the probability of cancer control at 5 years’ follow-up have varied among reporting centers, and series are small compared with surgery and radiation therapy.[13,14]
Candidates for definitive radiation therapy must have a confirmed pathological
diagnosis of cancer that is clinically confined to the prostate and/or
surrounding tissues (stage I, stage II, and stage III). Patients should have a computed tomographic scan negative for metastases, but staging laparotomy
and lymph node dissection are not required. Prophylactic radiation therapy to
clinically or pathologically uninvolved pelvic lymph nodes does not appear to
improve overall survival or prostate cancer-specific survival.[15][Level of
evidence: 1iiA] In addition, patients considered poor medical candidates for
radical prostatectomy can be treated with acceptably low complications if care
is given to the delivery technique.[16] Long-term results with radiation therapy
are dependent on stage. A retrospective review of 999 patients treated with
megavoltage radiation therapy showed cause-specific survival rates to be
significantly different at 10 years by T-stage: T1 (79%), T2 (66%), T3 (55%),
and T4 (22%).[17] An initial serum prostate-specific antigen (PSA) level >15 ng/mL is a predictor of probable failure
with conventional radiation therapy.[18]
Interstitial brachytherapy has been employed in several centers, generally for
patients with T1 and T2 tumors. Patients are selected for favorable
characteristics, including low Gleason score, low PSA level, and stage T1 to T2
tumors. Information and further study are required to better define the
effects of modern interstitial brachytherapy on disease control and quality of
life and to determine the contribution of favorable patient selection to
outcomes.[19][Level of evidence: 3iiiDiii]
Asymptomatic patients of advanced age or with concomitant illness may warrant
consideration of careful observation without immediate active treatment.[20,21] One population-based study with 15 years of follow-up (mean
observation time = 12.5 years) has shown excellent survival without any treatment
in patients with well-differentiated or moderately well-differentiated tumors clinically
confined to the prostate, irrespective of age.[8] None of these men were detected by PSA screening, since PSA was not available at the time. The patient cohort was followed for a mean of 21 years after initial diagnosis.[22] The risk of prostate cancer progression and prostate cancer death persisted throughout the follow-up period. By the end of follow-up, 91% of the cohort had died, 16% had died of prostate cancer. A second, smaller
population-based study of 94 patients with clinically localized prostate cancer
managed by a watch and wait strategy gave very similar results at 4 to 9
years of follow-up.[23] In a selected series of 50 stage C patients,
48 of whom had well-differentiated and moderately well-differentiated tumors, the prostate
cancer-specific survival rates at 5 and 9 years were 88% and 70%, respectively.[9]
Long-term follow-up of a population-based cohort of 767 men with clinically localized prostate cancer diagnosed in the pre-PSA era and managed with either watchful waiting or androgen withdrawal has also been reported in the United States.[24][Level of evidence: 3iiiA] After a follow-up of 20 years, prostate cancer-specific mortality was 6 per 1,000 person-years in men with Gleason scores of 2 to 4. Men with Gleason scores of 8 to 10, however, had a prostate-specific mortality of 121 per 1,000 person years, and men with Gleason scores of 5 to 7 had intermediate prostate cancer mortality (i.e., 12, 30, and 65 deaths per 1,000 person years for Gleason scores 5, 6, and 7, respectively).
Since the early 1980s, a dramatic increase has occurred in the rates of radical
prostatectomy in the United States for men aged 65 to 79 years (5.75-fold rise from
1984 to 1990). Wide geographic variation is seen with these rates.[25] A structured literature review of 144 papers has
been done in an attempt to compare the 3 primary treatment strategies for
clinically localized prostate cancer:[26]
- Radical prostatectomy.
- Definitive
radiation therapy.
- Watchful waiting.
The authors concluded that
poor reporting and selection factors within all series precluded a valid
comparison of efficacy for the 3 management strategies. In another literature review of a case series of patients with
palpable, clinically localized disease, the authors found that 10-year prostate
cancer-specific survival rates were best in radical prostatectomy series (about
93%), worst in radiation therapy series (about 75%), and intermediate with
deferred treatment (about 85%).[27] Because it is highly unlikely that radiation
therapy would worsen disease-specific survival, the most likely explanation is that
selection factors affect choice of treatment. Such selection factors make
comparisons of therapeutic strategies imprecise.[28] A retrospective analysis of outcomes of
men demonstrated a 10-year disease-specific
survival rate of 94% for expectant management for Gleason score 2 to 4 tumors
and 75% for Gleason score 5 to 7 tumors;[29] this is similar to a previous study
using the Surveillance, Epidemiology, and End Results database with survival
rates of 93% and 77%, respectively.[30]
A randomized trial comparing radical prostatectomy to watchful waiting in men with early-stage disease in the pre-PSA screening era (clinical stages T1b, T1c, or T2) showed a statistically significant difference in overall survival at 10 years.[31][Level of evidence: 1iiA] (See stage II and treatment section below for additional details.) After 10 years, the difference in overall survival was approximately 73% versus 68%; absolute difference 5.0%; relative risk of death 0.74 (95% confidence interval, 0 .56 to 0.99). This benefit was restricted to men P = .01 in a planned subset analysis of the effect of age on treatment efficacy).[32] Results from an ongoing randomized trial in the United States comparing radical prostatectomy to watchful waiting (PIVOT: Prostate Intervention Versus Observation Trial) have not been reported.[33] The PIVOT uses overall mortality as its primary endpoint.
Surgical complications
Complications of radical prostatectomy can include urinary incontinence,
urethral stricture, impotence, and the morbidity associated with general
anesthesia and a major surgical procedure. An analysis of Medicare records on
101,604 radical prostatectomies performed from 1991 to 1994 showed a 30-day
operative mortality rate of 0.5%, a generic sildenafil citrate rate of 4.5%, and a
major complication rate of 28.6%; over the study period, these rates decreased
by 30%, 8%, and 12%, respectively.[34] Prostatectomies done at hospitals where
fewer prostatectomies were performed were associated with higher rates of 30-day postoperative mortality, major acute surgical complications, longer
hospital stays, and higher rates of rehospitalization than those done at
hospitals where more prostatectomies were performed. Morbidity and mortality
rates increase with age.[25,35] Comorbidity, especially underlying cardiovascular disease and a history of stroke, accounts for a portion of the age-related increase in 30-day mortality. In a cohort of all men with prostate cancer who underwent radical prostatectomy from 1990 to 1999 in Ontario, 75-year-old men with no comorbidities had a predicted 30-day mortality of 0.74%.[35] Thirty-day surgical complication rates also depended more on comorbidity than age (i.e., about 5% vs. 40% for 0 vs. 4 or more underlying comorbid conditions).
In one large case series of men undergoing the anatomic (nerve-sparing) technique
of radical prostatectomy, only about 6% of men required the use of pads for
urinary incontinence, but an unknown additional proportion of men had
occasional urinary dribbling. About 40% to 65% of men who were sexually potent
before surgery retained potency adequate for vaginal penetration and sexual
intercourse.[36] Preservation of potency with this technique is dependent on
tumor stage and patient age, but the operation probably induces at least a
partial deficit in nearly all patients.[36]
A national survey of Medicare patients who underwent radical prostatectomy in
1988 to 1990 reported more morbidity than in the case series.[37] In that
survey, more than 30% of men reported the need for pads or clamps for urinary
wetness, and 63% of all patients reported a current problem with wetness. About
60% reported having no erections since surgery; about 90% had no erections
sufficient for intercourse during the month before the survey. About 28%
reported follow-up treatment of cancer with radiation therapy and/or hormonal therapy
within 4 years after their prostatectomy.
In a population-based longitudinal cohort (Prostate Cancer Outcomes Study) of
901 men aged 55 to 74 years who had recently undergone radical prostatectomy
for prostate cancer, 15.4% had either frequent urinary incontinence or no
urinary control at 5 years after surgery, and 20.4% wore pads to stay dry.[38] Inability to have an erection sufficient for intercourse was
reported by 79.3% of men. Reasons for the difference in outcomes
between the population-based surveys and previous case series could include:
-
Age difference among the populations.
- Surgical expertise at the major
reporting centers.
- Selection factors.
- Publication bias of favorable
series.
- Different methods of collecting information from patients.
Case
series of 93, 459, and 89 men who had undergone radical prostatectomy by
experienced surgeons showed rates of impotence as high as those in the
national Medicare survey when men were carefully questioned about sexual
potency, though the men in the case series were on average younger than those
in the Medicare survey.[39,40,41] One of the case series used the same questionnaire
as that used in the Medicare survey.[39] The urinary incontinence rate in that
series was also similar to that in the Medicare survey.
A cross-sectional survey of prostate cancer patients who had been treated in a
managed care setting by radical prostatectomy, radiation therapy, or watchful
waiting showed substantial sexual and urinary dysfunction in the prostatectomy
group.[42] Results reported by the patients were consistent with those from
the national Medicare survey. In addition, though statistical power was
limited, differences in sexual and urinary dysfunction between men who had
undergone either nerve-sparing or standard radical prostatectomy
were not statistically significant. This issue, therefore, requires more
study.
Radical prostatectomy may also cause fecal incontinence, and the incidence may
vary with surgical method.[43] In a national survey sample of 907 men who had
undergone radical prostatectomy at least 1 year before the survey, 32% of the
men who had undergone perineal (nerve-sparing) radical prostatectomy
and 17% of the men who had undergone retropubic radical prostatectomy reported
accidents of fecal leakage. Ten percent and 4% reported
moderate and large amounts of fecal leakage, respectively. Fewer than 15% of men with fecal
incontinence had reported it to a physician or health care provider.
Radiation therapy complications
Definitive external-beam radiation therapy can result in acute cystitis,
proctitis, and sometimes enteritis.[1,41,44,45,46] These conditions are generally reversible
but may be chronic and rarely require surgical intervention. Potency, in the
short term, is preserved with radiation therapy in most cases but may
diminish over time.[46] A cross-sectional survey of prostate cancer patients
who had been treated in a managed care setting by radical prostatectomy,
radiation therapy, or watchful waiting showed substantial sexual and urinary
dysfunction in the radiation therapy group.[42]
Morbidity may be reduced with
the employment of sophisticated radiation therapy techniques-such as the use of linear
accelerators-and careful simulation and treatment planning.[47] Radiation
side effects of 3-dimensional conformal versus conventional radiation
therapy using similar doses (total dose of 60-64 Gy) have been compared in a
randomized nonblinded study.[48][Level of evidence: 1iiC] No
differences were observed in acute morbidity, and late side effects serious enough to require
hospitalization were infrequent with both techniques; however, the cumulative
incidence of mild or greater proctitis was lower in the conformal arm than in
the standard therapy arm (37% vs. 56%, P = .004). Urinary symptoms were
similar in the 2 groups, as were local tumor control and overall survival rates
at 5 years follow-up.
Radiation therapy can be delivered after an
extraperitoneal lymph node dissection without an increase in complications, if
careful attention is paid to radiation technique. The treatment field should
not include the dissected pelvic nodes. Previous transurethral resection of the
prostate (TURP) increases the risk of stricture above that seen with radiation
therapy alone, but if radiation therapy is delayed 4 to 6 weeks after the TURP, the risk of
stricture can be minimized.[49,50,51] Pretreatment TURP to relieve
obstructive symptoms has been associated with tumor dissemination; however, multivariate
analysis in pathologically staged cases indicates that this is the result of a worse
underlying prognosis of the cases that require transurethral resection rather
than the result of the procedure itself.[52]
A population-based survey of Medicare recipients who had received radiation
therapy as primary treatment of prostate cancer (similar in design to the
survey of Medicare patients who underwent radical prostatectomy,[37] described above) has been reported, showing substantial differences in posttreatment
morbidity profiles between surgery and radiation therapy.[53] Although the men who had
undergone radiation therapy were older at the time of initial therapy, they were less
likely to report the need for pads or clamps to control urinary wetness (7%
vs. more than 30%). A larger proportion of patients treated with radiation
therapy before surgery reported the ability to have an erection sufficient for
intercourse in the month before the survey (men
Sildenafil citrate may be effective in the management of sexual dysfunction after radiation therapy in some men. In a randomized placebo-controlled crossover design study of 60 men who had undergone radiation therapy for clinically localized prostate cancer, and who reported erectile dysfunction that began after their radiation therapy, 55% reported successful intercourse after sildenafil versus 18% after placebo (P
A prospective community-based cohort of men 55 to 74 years treated with
radical prostatectomy (n = 1156) or external-beam radiation therapy (n = 435)
attempted to compare acute and chronic complications of the 2 treatment
strategies after adjusting for baseline differences in patient characteristics
and underlying health.[56] Regarding acute citrate sildenafil ups morbidity,
radical prostatectomy was associated with higher rates of cardiopulmonary
complications (5.5% vs. 1.9%), as well as the need for treatment of urinary
strictures (17.4% vs. 7.2%). Radiation therapy was associated with more acute
rectal proctitis (18.7% vs. 1.6%). With regard to chronic treatment-related
morbidity, radical prostatectomy was associated with more urinary incontinence
(9.6% vs. 3.5%) and impotence (80% vs. 62%). Radiation therapy was associated
with slightly greater declines in bowel function.
Hormone therapy complications
Several different hormonal approaches can benefit men in various stages of
prostate cancer. These approaches include bilateral orchiectomy, estrogen therapy, LHRH
agonists, antiandrogens, ketoconazole, and aminoglutethimide.
Benefits of
bilateral orchiectomy include ease of the procedure, compliance, its immediacy
in lowering testosterone levels, and low cost. Disadvantages include
psychologic effects, loss of libido, impotence, hot flashes, and
osteoporosis.[57]
Estrogens at a dose of 3 mg per day of
diethylstilbestrol will achieve castrate levels of testosterone. Like
orchiectomy, estrogens may cause loss of libido and impotence. Gynecomastia
may be prevented by low-dose radiation therapy to the breasts; however, estrogen is
seldom used today because of the risk of serious side effects, including
myocardial infarction, cerebrovascular accident, and pulmonary embolism.
LHRH
agonists such as leuprolide, goserelin, and buserelin will lower testosterone
to castrate levels. Like orchiectomy and estrogens, LHRH agonists cause
impotence, hot flashes, and loss of libido. Tumor flare reactions may occur
transiently but can be prevented by antiandrogens or by short-term estrogens at
low dose for several weeks.
The pure antiandrogen flutamide may cause
diarrhea, breast tenderness, and nausea. Case reports show fatal
and nonfatal liver toxic effects.[58] Bicalutamide may cause nausea, breast
tenderness, hot flashes, loss of libido, and impotence.[59] The steroidal
antiandrogen megestrol acetate suppresses androgen production incompletely and
is generally not used as initial therapy.
Long-term use of ketoconazole can
result in impotence, pruritus, nail changes, and adrenal insufficiency.
Aminoglutethimide commonly causes sedation and skin rashes. A national Medicare survey of men who had undergone radical prostatectomy for prostate cancer showed a decrease in all 7 health-related quality-of-life measures (impact of cancer and treatment, concern regarding body image, mental health, general health, activity, worries about cancer and dying, and energy) in men who had received androgen depletion therapy (either medically or surgically induced) versus those who had not.[60][Level of evidence: 3iC] Additional studies
that evaluate the effects of various hormone therapies on quality of life are
required.[61]
Androgen deprivation therapy also can cause osteoporosis and bone fractures. In a population-based sample of 50,613 Medicare patients aged 66 or older followed for a median of 5.1 years, men who had been treated with either a gonadotropin-releasing hormone (GnRH) or orchiectomy had a 19.4% bone fracture rate compared to 12.6% in men who had not received hormone deprivation therapy. The effect was similar in men whether or not they had metastatic bone disease.[62] A small nonblinded
study with short follow-up suggests that the bisphosphonate pamidronate can
prevent bone loss in men receiving a GnRH agonist for
prostate cancer.[63] Forty-seven prostate cancer patients (41 evaluable) with
locally advanced prostate cancer, but with no known bone metastases, were randomly
assigned to receive 3-monthly depot leuprolide with or without pamidronate (60
mg intravenously). No bone fractures were reported in either group. The
use of surrogate endpoints and unblinded assessment of endpoints makes it
difficult to know with certainty whether pamidronate use would prevent
fractures.[63][Level of evidence: 1iiDii]
The designations in PDQ that treatments are standard or under clinical
evaluation are not to be used as a basis for reimbursement determinations.
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