5. ACTIVE SURVEILLANCE…
WATCHFUL WAITING
Active surveillance and watchful waiting are almost unique to
prostate cancer.
Watchful waiting refers to monitoring the patient until he develops
metastases that require palliative treatment.
Active surveillance or expectant management allows delayed
primary treatment if there is biochemical or histologic evidence of
cancer progression.
6. Active surveillance is a less established strategy in patients with a
long life expectancy because criteria for selecting candidates and
trigger points for instituting treatment have yet to be defined and
validated.
Currently, treatment is frequently initiated because of the
patient’s anxiety from living with untreated cancer combined with a rising PSA
level or
biopsy findings that suggest an increase in the volume or Gleason grade of
the cancer.
7.
8.
9. Traditionally, deferred treatment has been reserved for men with a
life expectancy of less than 10 years and a low-grade (Gleason
score 2 to 6) prostate cancer.
However, active surveillance is now being evaluated as a
management strategy in younger patients with low-volume, low-
or intermediate-grade (up to Gleason score 3 + 4 = 7) tumors to
avoid or to delay treatment that might not be immediately
necessary.
In the very long-term follow-up (>30 years), there is a significant
risk of cancer progression and prostate cancer–specific death in
men with untreated localized prostate cancer.
10. In one study, approximately 16% of patients with newly diagnosed
prostate cancer would fulfill the criteria for active surveillance and
an additional 4% who did not meet all criteria chose surveillance
In this study, local progression (41%) and distant metastasis
(18%) developed from localized prostate cancer.
Certain populations should be approached with an even greater
level of caution when considering active surveillance.
11. In African- American men, the progression risk was significantly
increased in active surveillance.
In addition, African-American men who were candidates for active
surveillance criteria had worse clinicopathologic features on final
surgical pathology than Caucasian men.
Also, patients with BRCA2 mutations have higher Gleason
scores, more advanced tumor stage, and shorter median survival;
therefore they are not suitable candidates for active surveillance.
12. Statistical models have been generated in an attempt to predict
which tumors can be observed without aggressive treatment.
For example, Epstein and associates proposed a model involving
preoperative clinical and pathologic features that would predict
“insignificant tumors” (tumor volume less than 0.2 mL, Gleason
score below 7, and organ-confined cancer)
13. Characteristically for statistical models, this model was reported to
have a predictive value of 95% for identifying a “significant”
cancer but a predictive value of only 66% for identifying an
“insignificant” cancer.
Subsequently, Epstein and colleagues updated the model to
include a free/total PSA ratio (0.15) and favorable needle biopsy
findings (fewer than three cores involved, no core with more than
50% tumor, and Gleason score of 6 or lower)
14. A potential untoward consequence of
recommending active surveillance for all men who
do not have obviously aggressive, clinically
localized disease is that
only men with clearly aggressive and often incurable disease
would be treated immediately, whereas
a substantial proportion of those with curable disease destined to
progress would be managed with surveillance, often with multiple
extended biopsy procedures that could
contribute to infections,
cause erectile dysfunction,
complicate subsequent attempts at nerve-sparing surgery, and
delay treatment until the window of opportunity for cure had closed.
15. All prostate cancer patients are at risk for progression.
In reports of active surveillance, patients are usually observed
with semiannual PSA determinations and DRE and annual
biopsies.
Intervention is recommended if Gleason pattern 4 or 5 is present,
more than two biopsy cores are involved, or more than 50% of a
biopsy core is involved.
16. Progression is more likely in patients who have cancer present on
every biopsy procedure.
The absence of cancer on repeated biopsy significantly
decreases the likelihood of progression.
Accordingly, biopsy criteria have been reported to be more
accurate than PSA criteria in predicting progression.
Perineural invasion on biopsy during active surveillance is not
associated with adverse pathologic outcomes.
No study has found DRE or imaging studies to independently
predict progression.
17. In most studies of active surveillance, approximately 25% to 50%
of patients, depending on their individual risk factors, develop
objective evidence of tumor progression within 5 years.
Among patients who underwent radical prostatectomy for
evidence of cancer progression during active surveillance, 58%
had tumor extension beyond the prostate, and 8% had lymph
node metastases.
18. One rationale for active surveillance is the belief that there is
substantial overdiagnosis of prostate cancer as a result of
widespread PSA screening coupled with aggressive biopsy
regimens.
Overdiagnosis often refers to a cancer detected by screening that
would not be detected during the patient’s lifetime without
screening or would never cause disability or death .
It is axiomatic that any effort to detect cancer early will involve
detection of some cancers that would not have been otherwise
detected.
Therefore, some overdiagnosis is necessary to reduce suffering
and death from prostate cancer.
19. Some reports have estimated that 50% or more of prostate cancer
cases are overdiagnosed .
Epidemiologic estimates from the United States yield a 23% to
28% incidence of possible overdiagnosis .
Estimates in surgically treated patients based on clinicopathologic
data range from 6% to 20%.
Estimates of overdiagnosis derived from older men should not be
generalized to younger men.
20. At present, no tumor marker or algorithm can identify indolent
tumors with certainty.
21. Treatment is more likely to be successful if given earlier while the
tumor is smaller and the prospects for potency-sparing surgery
are greater.
Deferred treatment is more appropriate for older patients with a
limited life expectancy or comorbidities.
Additional clinical and laboratory research are needed to define
the parameters for safe use of active surveillance in younger men,
including the appropriate selection criteria, follow-up procedures,
and trigger points for intervention
22. For the present, patients who opt for active surveillance
should be evaluated with DRE and PSA testing quarterly or semiannually and
should consider undergoing repeated prostate biopsy procedures yearly or biennially.
23. Although it is assumed that quality of life should be largely
preserved with active surveillance, studies have demonstrated
significant decrements in quality of life with time, including waning
erectile function, diminished urinary continence, and adverse
psychological effects from living with untreated cancer
24. If surveillance biopsy specimens show evidence of increased
involvement by cancer, treatment should be instituted if the
patient is otherwise healthy and has a 10-year or greater life
expectancy.
A rising PSA level alone is not an absolute indication for
treatment in the active surveillance population;
however, as stated earlier, PSA velocity risk count and [−2]
proPSA are associated with risk for reclassification on active
surveillance.
25. In patients with a consistent PSA velocity exceeding 0.35
ng/mL/yr, there is a fivefold increased risk of prostate cancer
death in the next two to three decades
26. Patients may change their mind about remaining on an active
surveillance protocol;
therefore the physician should review management options on
follow-up visits.
28. Radical prostatectomy was the first treatment used for prostate
cancer and has been performed for almost 150 years.
Technically formidable
Side effects++
29. However, no treatment has supplanted radical prostatectomy, and it still
remains the gold standard because of the realization that
hormone therapy and chemotherapy are never curative, and
not all cancer cells can be eradicated consistently by radiation or other physical forms of
energy, even if the tumor is contained within the prostate capsule.
Moreover, if the prostate gland remains in situ, it is possible for new
prostate cancers to develop in the retained prostatic epithelium.
30. Innovations have led to the wider use of radical prostatectomy:
1. The development of the anatomic radical retropubic
prostatectomy, which allows the
dissection to be performed with good visualization and
preservation of the cavernous nerves responsible for erectile function and
preservation of the external sphincter muscle and yields urinary continence
rates in excess of 90% .
31. 2. The development of extended ultrasound-guided biopsy
regimens, performed with local anesthesia as office procedures.
3. The widespread use of PSA testing, which has led to the
majority of patients being diagnosed with clinically localized
disease
32. The main advantage of radical prostatectomy is that it offers the
possibility of cure with minimal collateral damage to surrounding
tissues if it is skillfully performed.
Furthermore, it provides more accurate tumor staging by
pathologic examination of the surgical specimen.
33. Also, treatment failure is more readily identified, potentially
curative salvage radiotherapy can be undertaken, and the
postoperative course is much smoother than in the past.
Some patients with tumor recurrence after radical prostatectomy
can be successfully treated with potentially curative postoperative
radiotherapy.
34. The potential disadvantages of radical prostatectomy are the
necessary hospitalization and recovery period;
a possibility of incomplete tumor resection, if the operation is not performed
properly or if the tumor is not contained within the prostate gland; and
a risk for erectile dysfunction and urinary incontinence.
35. Most prostate cancer patients have similar priorities.
First they want to survive.
Next, they want to remain continent.
Third, they want to preserve their potency.
These are their main priorities, but they want all three.
This constellation of favorable outcomes is known as the “trifecta”
37. PERINEAL
Total Perineal Prostatectomy is an acceptable surgical treatment when performed by a
surgeon familiar with this approach.
ADVANTAGES DISADVANTAGES
It is usually associated with
less blood loss and
a shorter operative time than
the retropubic approach.
It does not provide access for
a pelvic lymph node
dissection
Higher rate of rectal injury.
Occasional postoperative
fecal incontinence that does
not occur commonly with
other approaches
38. RETROPUBIC
The open retropubic approach was
popularized because of
surgeons’ familiarity with the surgical anatomy;
the lower risk for rectal injury and postoperative fecal
incontinence;
the wide exposure and ready access provided for pelvic
lymphadenectomy;
prostate excision with preservation of the neurovascular
bundles;
the lower risk for cancer at the surgical margins.
39. LAPAROSCOPIC
The laparoscopic approach is the most daunting
method of performing radical prostatectomy.
It has been suggested that laparoscopic prostatectomy
may be associated with
less bleeding,
better visualization,
less postoperative pain &
shorter convalescence than the standard open approach.
40. LAP EXTRA / INTRA PERITONEAL
APPROACHES
Laparoscopic prostatectomy can be performed through a
transperitoneal or extraperitoneal approach, but the
extraperitoneal approach poses logistical limitations, especially
with the use of robotic assistance.
The transperitoneal approach facilitates the lymphadenectomy but
carries a higher risk of
intestinal and vascular injury,
urinary ascites,
postoperative ileus and
intestinal obstruction.
41. The laparoscopic approach, though associated with
less blood loss, of greater concern, it had higher rates
of
postoperative emergency room visits
readmissions to the hospital, and
further surgery for complications.
Also, patients who underwent a laparoscopic radical
prostatectomy were less likely to become continent
than those treated with open prostatectomy.
42. When laparoscopic prostatectomy is performed by a
skilled laparoscopic surgeon, reported continence and
anastomotic stricture rates are comparable to those
achieved with open surgery.
The early reported rates of positive surgical margins
have been higher with laparoscopic prostatectomy,
and the adequacy of cancer control is as yet uncertain
because of lack of long-term results
43. ROBOTIC
Since the introduction of the da Vinci Surgical
System in 2000, the majority of radical
prostatectomies in the United States have been
performed robotically.
Robotic prostatectomy became popularized
because of
its greater technical ease for the surgeon, especially for tying
sutures and performing the vesicourethral anastomosis, and
lower blood loss, as in all laparoscopic approaches.
44. LAP X ROBOTIC
Standard lap Robo assisted
Technically daunting
Steep learning curve
3D visualisation+
Enhanced dexterity
Technically feasible for many
surgeons
45. No superiority seen between robotic and open
radical prostatectomy for functional or
oncologic outcomes.
Comparative studies have shown that open
prostatectomy has a similar recovery time and
return to normal activity.
46. Meanwhile, robotic prostatectomy was associated with
a significantly lower transfusion rate and shorter
hospital stays compared with open radical
prostatectomy but a higher rate of incisional
Hernias.
Perhaps the most important consideration is that
neither the laparoscopic nor the robotic approach has
as long a track record of cancer control compared with
the open approach.
47. A comparison of a sample of patients from the
Medicare database who underwent minimally
invasive or open prostatectomy in the earlier
adoption period for robotic prostatectomy, 2003 to
2005, revealed
similar overall complication rates between minimally invasive and open
prostatectomies;
however, the men undergoing minimally invasive prostatectomy had
more than a threefold higher rate of requiring salvage therapy for
tumor recurrence within 6 months of surgery
48. PATIENT SATISFACTION / REGRET
Patients who underwent robotic prostatectomy were
more than four times more likely to regret their
decision .
These patients were more likely to be regretful and
dissatisfied because of the higher expectations for an
“innovative” procedure.
These results raise concerns that patients are being
misled about the true risks and benefits of minimally
invasive procedures to treat prostate cancer.
49. Thus, the long-term outcome of cancer control is better
documented for open prostatectomy.
50. The recommendation for patients considering
surgical treatment of their prostate cancer
should be
not to choose a technique but
to choose an expert in a given technique.
The importance of the surgeon’s experience in
reducing complications is well documented.
51. HOW TO SELECT A PATIENT for
Radical Prostatectomy ?...
An ideal candidate for radical prostatectomy is healthy and
free of comorbidities that might make the operation
unacceptably risky.
He should have a life expectancy of at least 10 years.
His tumor should be deemed to be biologically significant
and completely resectable.
The generally accepted upper age limit for radical
prostatectomy is about 76 years.
52. Because imaging studies are not accurate for staging prostate
cancer, preoperative clinical and pathologic parameters are often
used to predict the pathologic stage and thus identify patients
most likely to benefit from the operation.
53. Patients with a low probability of resectable disease or a short life
expectancy should not be advised to have surgery.
Neoadjuvant hormone therapy does not enhance the resectability
of prostate cancer and often increases the difficulty of performing
nerve-sparing surgery.
Similarly, neoadjuvant chemotherapy rarely produces pathologic
complete Responses.
54. The feasibility of performing nerve-sparing surgery is
questionable when there is
extensive cancer in the biopsy specimens,
palpable extra prostatic tumor extension,
serum PSA level above 10 ng/mL,
biopsy Gleason score higher than 7,
poor-quality erections preoperatively,
current and future lack of a sexual relationship, or
other medical conditions that may adversely affect erections (e.g.,
diabetes mellitus, hypertension, psychiatric diseases, neurologic
diseases, or medications that produce erectile dysfunction).
55. Postoperative treatment of erectile dysfunction
also should be discussed, including information
on
phosphodiesterase type 5 (PDE5) inhibitors
intraurethral and intracorporeal administration of vasodilators,
vacuum erection devices,
venous flow constrictors, and
implantable penile prostheses.
56. SURGICAL TECHNIQUE
Radical prostatectomy involves
complete removal of the prostate
gland and seminal vesicles and
usually includes a modified pelvic
lymph node dissection as well.
57. 1. Pelvic lymphadenectomy
2. Opening of the endopelvic fascia and limited incision of the
puboprostatic ligaments
3. Suture ligation and transection of Santorini dorsal venous
complex
4. Dissection of the urethra at the apex of the prostate and
transection of the urethra
58. 5. Dissection of the prostate from the neurovascular bundles
6. Securing and transection of the prostatic pedicles
7. Transection and reconstruction of the bladder neck
8. Dissection of the seminal vesicles and ampullary portions of the
vasa deferentia
9. Performance of the vesicourethral anastomosis
59. Pelvic lymphadenectomy is optional in
patients at low risk for lymph node
metastases.
In fact, pelvic lymphadenectomy has been
less frequently performed with robotic
prostatectomy.
60. The key to preserving urinary continence is to perform
a meticulous dissection, avoiding injury to the external
urinary sphincter.
61. Meticulous dissection is also required to preserve the
neurovascular bundles.
In performing nerve-sparing surgery, the neurovascular
bundles are identified at the apex of the prostate.
The dissection can also be performed in an antegrade
fashion beginning at the base.
62. The bundles are dissected free of the posterolateral
surface of the prostate gland.
Hemostatic sutures or clips may be used to control
bleeding from the neurovascular bundles.
Use of electrocautery or a harmonic scalpel risks
irreversible thermal injury to the neurovascular
bundles.
63. POSTOPERATIVE CARE
Patients should ambulate with assistance beginning on
the afternoon or evening of surgery.
The catheter may be removed 3 to 21 days after
surgery, depending on the integrity and the amount of
tension on the vesicourethral anastomosis.
Removal of the catheter before 7 days is associated
with a 15% to 20% risk of urinary retention.
64. After the catheter has been removed, Kegel exercises
should be initiated.
A protective pad is used until complete urinary control is
achieved.
The postoperative serum PSA level should be undetectable
by 1 month after the operation.
Ultrasensitive PSA measurements frequently falsely classify
patients as having tumor recurrence.
65. CANCER CONTROL
The principal objective of radical prostatectomy is to
completely excise the cancer.
Important cancer control end points are
pathologically organ-confined disease with clear surgical margins,
biochemical recurrence (detectable serum PSA),
local progression,
metastases,
cancer-specific survival &
overall survival.
66. Depending on the Gleason score and
the PSA doubling time, biochemical
(PSA) evidence of recurrence usually
precedes
clinical metastases by a mean of about 8 years
and
cancer-specific mortality by about 13 years.
67. Nonprogression rates vary with clinical and pathologic risk factors.
Independent clinical prognostic factors are
tumor stage,
Gleason score,
preoperative PSA level, and
treatment.
68. Adverse prognostic features include
non–organ-confined disease
lymphovascular space invasion,
extracapsular tumor extension,
positive surgical margins,
seminal vesicle invasion, and
lymph node metastases.
In the PSA era, there has been a dramatic
improvement in prognostic features and treatment
outcomes
69. A rising serum PSA level is usually the
earliest evidence of tumor recurrence
after radical prostatectomy.
Biochemical recurrence is frequently
used as an intermediate end point for
treatment outcomes;
70. However, not all patients with biochemical
recurrence ultimately develop metastases or die of
prostate cancer.
In rare instances with high-grade or
neuroendocrine tumors that do not produce much
PSA, there can be palpable evidence of
recurrence despite an undetectable PSA level,
indicating a role for DRE in monitoring of patients.
71. In hormone therapy–naive men after radical
prostatectomy, the median PSA at the time of a
newly detected bone metastasis was 32 ng/mL,
although a quarter of those metastases occurred
at PSA levels of less than 10 ng/mL.
Lower PSA at initial diagnosis of prostate cancer
and higher Gleason score were correlated with
metastasis development at lower PSA level.
72. The hazard of prostate cancer–specific recurrence
continues to increase for at least 15 years after radical
prostatectomy, and the risks for mortality may increase for
25 years or more.
Therefore it is important to continue to monitor patients long
after surgery
Radical prostatectomy also provides long-term cancer
control in about half of highly selected men with high-risk or
locally advanced disease
73. URINARY CONTINENCE
In general, urinary continence after radical retropubic
prostatectomy is good and varies according to the experience and
skill of the surgeon.
The return of urinary continence is associated with the patient’s
age:
Approximately 95% of men younger than 60 years can attain
padfree urinary continence after surgery;
85% of men older than 70 years regain continence.
Relatively few require implantation of an artificial urinary sphincter
or a sling procedure for stress urinary incontinence.
74. ERECTILE FUNCTION
The return of erectile function after
radical prostatectomy correlates with the
age of the patient,
preoperative potency status
extent of nerve-sparing surgery, and
era of surgery.
75. Erections usually begin to return as partial erections 3
to 6 months after surgery and may continue to improve
for up to 3 years or more.
Patients should be encouraged to use erectile aids
postoperatively, including
PDE5 inhibitors,
intraurethral suppositories,
intracavernosal injections, or
vacuum erection devices.
76. COMPLICATIONS - EARLY & LATE
Anatomic nerve-sparing radical prostatectomy
provides excellent cancer control with an
acceptable complication rate in appropriately
selected patients.
The overall early complication rate after radical
prostatectomy is less than 10% in experienced
hands.
77. EARLY COMPLICATIONS
Early complications include
Hemorrhage;
rectal, vascular, ureteral, and nerve injury;
urinary leak or fistula;
thromboembolic and cardiovascular events;
urinary tract infection
lymphocele; and
wound problems.
78. OBTURATOR NERVE INJURY
Inadvertent injury to the obturator nerve can occur during the
pelvic lymphadenectomy.
When a tension-free primary nerve repair is not feasible, nerve
grafting can be performed by a cutaneous or genitofemoral nerve
graft.
However, even without a nerve repair, conservative management
with physical therapy can compensate for the deficit.
Therefore many patients do not have a significant thigh adductor
deficit after the injury.
79. URETERAL INJURY - MINOR &
SEVERE
Ureteral injury is a rare complication.
A minor injury or ligation can be managed with
removal of the ligature and ureteral stenting.
Mobilization of the distal ureter and
reimplantation should be performed for more
severe injuries.
80. RECTAL INJURY
Although uncommon, a rectal injury can occur
and be repaired primarily by a multiple-layer
closure.
However, a diverting colostomy should be
considered in men with
1. a large rectal defect,
2. a history of pelvic radiotherapy, or
3. long-term preoperative glucocorticoid therapy.
81. LATE COMPLICATIONS
The most common late complications of radical
prostatectomy are
1. erectile dysfunction,
2. urinary incontinence,
3. inguinal hernia,
4. incisional hernia with laparoscopic and robotic
prostatectomy, and
5. urethral stricture.
82. MANAGEMENT OF POSTOPERATIVE
BIOCHEMICAL RECURRENCE
Patients with detectable PSA (>0.1 ng/mL)
after radical prostatectomy usually have
persistent cancer, although some have only
retained benign prostate tissue causing the
PSA elevation.
In the latter case, the serum PSA level
increases slowly.
83. Of patients destined to have biochemical
recurrence after radical prostatectomy,
approximately
50% of recurrences appear within 3 years,
80% within 5 years,
99% within 10 years &
rarely, recurrences appear more than 15 years.
84. How rapidly the tumor is likely to
progress is reflected by
The PSA velocity or doubling time
the interval from surgery to biochemical
recurrence, and
the Gleason score.
85. In a study of men with a rising PSA after radical
prostatectomy who did not receive immediate
radiation therapy,
the median time to metastases was 8 years after PSA
elevation,
but only 34% of men developed clinically apparent
metastases.
If salvage radiotherapy is planned, it should be
initiated before the PSA level rises much above
0.5 ng/mL.
86. Patients most likely to have favorable
responses to salvage radiotherapy are
those with
1. PSA recurrence long after surgery,
2. a slowly rising PSA,
3. low-grade tumor, and
4. no seminal vesicle invasion or lymph node metastases.
87. The most appropriate PSA level at which to institute hormone
therapy is unknown.
Long-term, continuous hormone therapy is a/w substantial side
effects like
1. Decreased libido,
2. Impotence,
3. Hot flashes,
4. Osteopenia with increased fracture risk,
5. Metabolic alterations, and
6. Changes in mood.
Hence delayed or intermittent ADT is frequently used in patients
who have biochemical recurrence, especially those with a slowly
rising PSA level.
88. PREOPERATIVE ANDROGEN
DEPRIVATION THERAPY
Preoperative ADT has been studied for tumor downstaging before
radical prostatectomy in patients with locoregional prostate
cancer.
In general, the results have shown that although the rate of
positive surgical margins is reduced, there is no benefit in terms
of progressionfree survival in the overall study population.
Although preoperative ADT might not uniformly be beneficial for
localized disease, there might be a benefit in patients with high-
risk disease.
89. SALVAGE RADICAL
PROSTATECTOMY
Radical prostatectomy can be performed in patients in
whom other local treatments have failed.
However, the rate of complications is far higher, and the
complications are more serious and difficult to manage.
Moreover, the prospects for long-term disease-free survival
are more limited for salvage prostatectomy than for primary
radical prostatectomy.
90. Most of the reported experience with salvage radical
prostatectomy is from the pre-PSA era.
Contemporary series of patients selected because of
biochemical recurrence have lower morbidity and better
cancer control rates.
Nevertheless, postoperative incontinence rates are as high
as 44% and bladder neck contracture as high as 22%.
91. KEY POINTS: RADICAL
PROSTATECTOMY
Radical prostatectomy was the first treatment used for prostate
cancer, and it still remains the gold standard.
An ideal candidate for radical prostatectomy is a healthy man with
a life expectancy of at least 10 years.
Preoperative clinical and pathologic parameters are often used to
predict the pathologic stage and thus to identify patients most
likely to benefit from the operation.
92. A rising serum PSA level is usually the earliest evidence of tumor
recurrence after radical prostatectomy and is frequently an
intermediate end point for treatment outcomes.
However, not all patients with biochemical recurrence ultimately
develop metastases or die of prostate cancer.
93. The most common late complications of radical prostatectomy are
erectile dysfunction, urinary incontinence, hernia, and urethral
stricture.
The return of erectile function after surgery correlates with age of
the patient, preoperative potency status, extent of nerve-sparing
surgery, and era of surgery.
The return of urinary continence is associated with the patient’s
age.
The long-term outcome of cancer control is better documented for
open prostatectomy.