ORIGINAL
Brachytherapy in localized prostate cancer
Abascal Junquera JM*,Hevia Suarez
M, *Abascal García JM*, Abascal García R*, Gonzalez Suárez H**, Alonso A**,
Juan Rijo G**, Prada PJ**.
*Servicio Urología. **Servicio Radioterapia. Hospital Universitario Central
de Asturias. Spain
Actas Urol Esp.
2007;31(6):617-626
|
ABSTRACT |
|
Brachytherapy in localized
prostate cancer |
|
INTRODUCTION AND OBJECTIVES: There are currently minimally
invasive techniques that compete with classic surgery, taken into account the
high frequency of localized prostate cancer. One of them is the low dose rate
brachytherapy with permanent I-125 seed implants. |
|
The aim of this present study is to report our experience
from 1998 when we performed the first treatment until today. Results and
morbidity of patients with 7.5 years follow up are analyzed. |
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Material and Methods: A total of 800 patients were treated
with Low Rate Dose with a mean age of 68 years, range 48-83. In all patients
I125 seeds were used with Rapid-Strand with peripheral load technique and by
intraoperative planning. |
|
Results: The urinary complications rate was of 3% Acute
urinary retention (AUR) and 0,2% of urinary incontinence. The morbidity on
the gastro-intestinal system was of 12% intermittent bleeding, 2% proctitis,
and 0,3% rectal fistulas. |
|
Key Words:
Brachytherapy. Localized Prostate Cancer. |
It is known that prostate carcinoma is the second cause of cancer death
in men, and its incidence is increasing, whether by the aging of the
population, greater precision in the screening or the increase in the
systematic number of prostate biopsies.
The result of all these factors is a great increase in the diagnosis of
cancer localized inside the gland, and therefore susceptible to a curative
treatment, and also increasingly seen in younger people.
The possibilities of treatment in these selected cases range from
monitoring and surveillance to radical prostatectomy, with its variants of
laparoscopic surgery, with or without robot, and less invasive techniques such
as brachytherapy, cryotherapy or conformed radiotherapy.
Small changes in long-term results irrespective of the technique used,
and lower morbidity of the latter is what prompted their development, and
introduced in the range of therapeutic possibilities in the treatment of
localized prostate carcinoma1.
Techniques increasingly evolved, tend to minimize the surgical
aggression, comparing, often when carcinoma is more localized and better
differentiated, the survival to the open radical prostatectomy and laparoscopic
surgery.
The technical evolution of the old axioms, improving the incision,
bleeding, time of hospital stay, and complications. So the open surgery is
matched by results with the laparoscopic, robotic laparoscopic and improved in
the areas commented before.
Also in radiation occurs in a similar manner, and since the beginning of
the last century, Young 1910, Pasteau 19142 used radio by intraurethral via,
Barringer3
later implemented the transperineal route; Flocks via retropubic initiated
treatment by colloidal Aurum, and then Whitmore4 with I125 in New York.
Hans Holm at the
Brachy comes from the Greek word "brachys", which means short,
hence brachytherapy is the treatment by encapsulated radioactive sources
applied within walking distance of tissue to be treated.
We will refer to interstitial brachytherapy that is the one by which
some hollow needles are used to be implemented inside the tissues. There are
two types of interstitial brachytherapy with temporary and with permanent
implant. In the temporary we place the needle directed by ultrasound, via
transperineal, in the prostate; the needles are hollow and a unique irradation
dose is administered, in a few minutes, and through a machine of automated
deferred load.
The radioactive element that provides that irradiation is the iridium
192 (high dose rate). Once treatment is finished the implant is removed and
treatment is repeated at 15 days, and then supplemented with external radiotherapy.
(Protocol HDR in Phase II).
In the case of low dose rate permanent implant the same technique
applies, but using I125 or Palladium radioactive seeds, which remain within the
prostate, and are evenly distributed to achieve a complete gland irradiation.
The first implant to be practiced in our country, interstitial
type with Au198, approaching the gland via retropubic (Pfannestield), was
performed at the Hospital General de Asturias in 19817.
It was then about twenty patients, later supplemented with
external beam radiation. The technique was abandoned because of the need for
anesthesia, surgical approach, seeds placement by hand, high morbidity and as a
result, the uneven distribution of the implants and an uncontrolled dosage.
The development of imaging techniques, especially ultrasound with
rectal transducter and the implementation of programs for measuring and
planning dosimetry, give a major impulse to the technique.
In 1983, as already mentioned, Holm was the first to use, guided
by transrectal ultrasonography, the perineal route for seed implant. Later in
1984, Blasko and Radge in
On the other hand in 1987 in
The first treatment with I125 seeds was conducted for the first
time in
At
The brachytherapy, bearing in mind that prostate cancer is dose
dependent, allows the application of higher radiation doses, with up to 14,500
cGy Low rate as a single dose, and getting a comparable biological dose of
approximate 15,500 when linked with external radiation.
With the High Rate biological dose of cGy 12,000 to 13,000 cGy can
be achieved, while with external radiation we cannot exceed 7,500 cGy, and with
conformed the maximum dose is also 8.000cGy9,10.
It
also has as advantages that the dose fall outside the gland is fast, therefore
periprostatic tissues do not suffer radiation or to a very limited extent, and
being needles fixed at the time of implant it is not influenced by gland
movements. It is an ambulatory treatment, minimally invasive, with spinal
anesthesia and discharge without catheter in 6-8 hours.
On the contrary and as objections, the most important is the lack
of surgical staging, which also causes urinary discomfort in one third of
patients, and finally the PSA follow up, which has a behavior sometimes
capricious, and that till reaching Nadir in the first five years it can present
peaks creating uncertainty.
On the other hand, being a surgical technique, training is needed,
and today in our country is often necessary to have a multidisciplinary team
for its implementation. There is the possibility of obtaining the title of
radioactive isotopes operator-supervisor, for the urologist to have the
autonomy to perform the implant with the help of a physicist.
Indications
The indication of brachytherapy treatment following
the major American and European Societies, is in all patients with organ
confined cancer T1-T2, classified into three risk groups, using as predictive
parameters PSA dosage and Gleason degree; low risk of disease recurrence,
moderate or high risk11,12.
Contraindications
We have anesthetic problems, life expectancy of less than 5 years
and metastatic disease as formal technique contraindication, and other, which
are not technically unfeasible, but they have a high rate of complications as
in the prior radiotherapy pelvic or prostate surgery.
In all patients we performed a previous flowmetry, and
in those who have obstructive pattern, either by medium lobe neck disectasia or
urethral obstruction, a RTU, or previous urethrotomy is made, and in 12 weeks
brachytherapy.
In case of prostates larger than 60cc an implant can
be done, provided that such growth is not associated with an obstructive
process, taking care to make a lithotomy forced position to avoid the pubic
arch. All this without avoiding the hormonal blockade pretreatment and the
previous ascertainment of size reduction13.
In addition to this contraindications section it is
necessary to reflect on a chapter that in our opinion is very important, and
that there is not sufficient attention in the literature, despite its
relevance. We refer to the prior or concurrent rectal pathology. It is
advisable to take into account the existence of recent inguinal hernias,
changes in the intestinal transit, that can be satellite signs of tumor
pathology at colon or rectum level. Similarly attention must be paid to
cirrhosis profile, portal hypertension, prostate-haemorrhoidal syndrome, or
simple haemorrhoidal pathology. In these cases surgery is the preferable
solution 12 weeks prior to seeds implantation.
The pathology that we rule out previous to
brachytherapy is:
- Familial Polyposis
- Hairy Adenomas
- Ulcerative colitis
- Pathologies associated with rectal area as: Internal
or external, cryptitis, fissures...
As a warning is necessary to settle all previous
rectal pathology, and the rectal area cannot be involved, with limits on the
rectum-sygmoid junction till 12 months after brachytherapy.
The implant procedure
Once patient documented with PSA, ultrasound, histological
studies, flowmetry, history, and accepted for implant a preoperative study is
performed and seeds are requested.
Established by ultrasound prostate size, applying the ellipsoid
formula, following Wu nomogram depending on the prostate size, the activity per
seed is established. For prostates under 30cc would be between 0.38 and 0.41
mCi, between 30 and 50cc (0.48 to 0.52 mCi) and above 50cc 0.58 mCi14.
The
implants can be placed by preplanning technique, consisting in performing a
simulation of seeds situation two weeks in advance, and the day of the implant
trying to reproduce in the operating room the prior conformation.
The other system is the one we utilize in real time, being able to
make corrections during surgery. In principal it appears that the attempt to
reproduce the same anatomic position according to preplanning technique,
involves small errors, which are avoided with intraoperative. Also with the
latter agility and time are earned. There are few studies that establish the
comparative advantages and disadvantages of each, but we believe from the
experience of having used the two, that latter at least is faster, and allow
the adjustment of doses in overdosage or undosage areas13.
The prevalence of peripheral implant device on our center, makes
that 70-80% of the seeds will be deposited in the periphery, with an average of
12 to 15 needles, and only 3 or 4 at the central level.
The size is not a disadvantage for the implant, being in our
casuistry 9% of patients with a volume greater than 50cc and 3% exceeded 60cc.
The largest volume implanted was 94cc, with 169 seeds, which served not to
repeat the experience in similar cases, due we had problems of urinary
retention and urinary catheter for 6 weeks.
In lithotomy position under spinal anesthesia, sometimes
supplemented with sedation. The surgical field asepsis is performed, rejecting
the scrotal bag to better expose the perineum. A bladder catheter is placed
(Foley No 14) (Fig. 1).
FIGURE 1
The rectal transducer placed in the rack (Accuseed stepper)
is introduced (Fig 2), which immobilizes and allows an antero posterior
movement, and on top of it the template o graduate rack; ultrasound cuts are
given each 5 mm, since the apex to the base, identifying the urethra and
rectum. These cuts are transferred to a planner to calculate the proper seed
distribution.
FIGURE 2
The software used for the distribution of dose
calculation provided by seeds is specific from Varian Medycal Systems, Variseed
V7.115,16.
At present the dosimetric criteria are of receving
98-100% at least 100% of the prescribed dose, 75% of prostate volume 150%.
With the implant situation in the planner, we initiate
the needles placement in the patient, readjusting their position in the
software in real time, and performing a flexible cystoscopy to verify that
there are nor needles in the bladder,neither in the urethra.
Subsequently the seeds are charged in the needles and
placed in the prostate tissue. We use seeds in Rapid-Strand format, tied by a
thread of reasorbable material. This system has the advantage of diminishing
the probability of seeds migration rather than the loose implant method which
is more frequent17 (Fig. 3).
FIGURE 3. Seed.
Once the seeds are deposited, they are located in its
actual position and then the calculation of dosage distribtuion can be made
based on that position. This allows some changes at the time to complete the
implant if required18.
Effects
of radiation
The photons produced by the radioactive source has a direct action
on the DNA, RNA, enzymes, proteins and any cellular macromolecule causing cell
death, and indirectly has the same effect with the action of toxic substances,
radical, coming from the dissociation of water molecules absorbing radiation19.
The implanted seeds with Iodine 125 remain with the highest
radioactivity for 60 days, decreasing gradually until they disappear
approximately a year after.
Postimplant
In our series of more than 800 patients there has been
no intraoperative complications in the immediate postoperative32.
A simple X-ray of the abdomen helps us to verify the proper seeds
alignment. The catheter removal is carried out 4 hors after, and in 12 hours
the patient is discharged, prescribing anti-inflammatory, alpha blockers, low
molecular weight heparin, and a urinary antiseptic (Fig. 4).
FIGURE 4
Patients are given a manual with precautions and conduct to follow from
the placement of the implant, but given the low doses of implant radiation,
patients can afford to bear a normal social relationship31.
Follow up of patients is with a PSA dosage, every three months the first
two years, and every six months the following five years.
The biological recurrence is considered according to ASTRO, when there
is an elevation above Nadir in three consecutive measurements, or if following
RESULTS
We will describe the most common complication affecting the urinary
tract, the diggestive system and the sexual sphere of the 800 Iodine 125
implants perform by our group. The average age of our series is 68 years range
from 49 to 83.
Urinary Complications
Irritative type urinary symptons are very frequent, having them until
two thirds of patients; they are generally well tolerated with medical
treatment (alpha blockers and anti inflammatory), its intensity is in the
slight-moderated during first months relaxing over time, emphasizing that in
the majority of patients these symptons completely dissapear after a year
(Table 1).
Table 1
Incidence of urinary complications comparative table
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Medical Literature Data |
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Stock |
Wallner |
Beyer |
Blasko |
Own |
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|
|
|
|
|
Experience |
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Retention |
4% |
14% |
4% |
7% |
3% |
|
Incontinence |
0% |
0% |
0,6% |
0% |
0,2% |
In 14 patients we performed previous TUR, medium Lobe (5),
disectasia neck (4), prostate TUR (5), and in 1 case an internal Urethrotomy
due urethral stricture. The waiting time for the implant was 12 weeks.
This forecast may indeed have influence on the little clinical
obstructive our patients presented , with the exception of one case with 94 cc
prostate, which forced 6 weeks permanent catheter.
Regarding incontinence is minimal, with a 0.2% in our serie22. Radic lesions altering the sphincter area healing can
be the ones determining incontinence cases.
Rectal
Complications
The most often complications presented are rectitys, and
alterations in the bowel transit with diarrhea, which are of short duration.
Also the intermittent and autolimited rectorrhagias are present in up to 12%23-25.
But the greater concern in these patients with rectal clinic is to
prevent progression to recto-prostatic fistula avoiding maneuvers (biopsies,
cauterizes or surgery before one year after implant), as these manipulations
can seriously compromise the vitality of these tissues under radiation. The
improvement is achieved very often with corticoids enema26
(Table 2).
Table 2
Rectal disease incidence comparative table
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Published Series |
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Stock |
Wallner |
Blasko |
Beyer |
Own experience |
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Proctitis |
1,7% |
2% |
2% |
1% |
2% |
|
Rectorrhagias |
|
|
4%-11% |
|
12% |
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Rectal ulcer/fistula |
|
|
0,4-0,7% |
|
0,3% |
Sexual Disorders
Most
studies, as it happens with radical prostatectomy, reflected a variable
complications incidence, ranging from 14 to 50%, probably influenced by the
time of collecting the data, as impotence increases with time, it takes between
one and five years to show up and sometimes confusing aging physiological cases
with secondary to brachytherapy. In our series, the percentage is 65% average
on preserving sexual function over these 7.5 years. (Fig. 5).
FIGURE 5. Sexual function maintenance over time.
During the first year of treatment it is commom to have minor
ejaculation disorders, decrease or liquefaction of same. The treatment with
phosphodiesterase inhibitors are effective in 80% of cases27,28.
In any case it must be emphasized that is significantly lower than with
radical prostatectomy of external radiotherapy.
Biological Outcomes
The biological control of the disease it is performed with PSA dosage,
the first three months after, followed by quarterly analysis in the first two
years, and thereafter twice a year till fifth year and then annually.
The lowest figure PSA (nadir) can take up to two years to be achieved,
being a different figure for each individual. It is not abnormal that PSA
figures give small pick ups in the PSA in the first 5 years, which in principle
do not have any significance, and that are associated with inflammatory
processes.
DISCUSSION
PSA evolution in a group of 112 patients with a follow up of 7.5 years
is expressed in Fig. 6, where it is shown the standard deviation of mean PSA;
coinciding in essence with the published series, and although the a 7.5 years
follow-up is large, since recurrences in this type of cancer are long-term,
further studies are needed to confirm the good progress of biological
recurrence -free survival, which is 80%, as expressed in Fig. 7, with rates of
93 and 83% respectively for T1 and T2.
FIGURE 6. PSA Evolution in low rate dose (n = 112).
FIGURE 7. Results at 7.5 years.
Also overall
survival is 95%. It should be emphasized, as shown in Figure 8, the highest
percentage of T1 to 70%, compared with 27% of T2a, and only 3% of cases that go
beyond T2a.
FIGURE 8. Distribution by stage (n = 112).
The distribution
in Gleason terms, shown in Figure 9, with a marked predominance of the group
<7, 96%, compared to 4%> 7.
FIGURE 9. Distribution by Gleason.
PSA distribution
by ranges by demonstrates (see Fig. 10), how there is a strong patients
selection with 64% of them with less than 10 ng / ml.
FIGURE 10. PSA (ng/ml) distribution according to ranges.
With reference to obstructive type acute urinary complications after implant,
in our series are very few (3%), when comparing with other authors6,10,16,29,
(Table 1) we believe because of prior multiples precautions , flowmetry, previous
middle lobes or of cervical obstructive TUR, and the type of peripheral
implant, which produces less urethra acute inflammation. The procedure in
presence of prostates larger than 60cc, is the universal treatment with
androgen blockade, associated with or without to 5-a-reductase inhibitors for a
minimum period of four months prior to implant.
With regard to incontinence, the authors like Stock, Blasko, Wallner6,15,22,30,33 do not include it among its complications; in our
series, even minimal occupies a 0.2%. Radic lesions
altering the sphincter area healing can be the ones determining incontinence
cases. (Table 1).
Regarding rectal morbidity caused by the implant, as shown in Table 2,
slight ones like proctitis, occasional rectorrhagias, are not uncommon,
responding well to local treatment with ointments or corticoids enema42.
The most feared complication is the rectal fistula,
although in many cases, is preceded by a pre handling of rectum, before one
year after implant, on other occasions without any antecedent appears even 12
months after brachyteraphy26,39-41,43. The problem is difficult to
solve due the tissue alteration tissue which commits any reconstructive
surgery.
Our group performed for some time a technique to
protect the rectum, with hyaluronic acid injection in the virtual space
prostate rectal once needles are placed and before loading the radioactive
seeds. The high perirectal radiation absorption, minimizes local complications.
The treatment results with Restylene® injection are accepted for
publication in the International Journal of Radiation Oncology (Fig. 11).
FIGURE 11. MRI infiltration with Restylene®.
Referring to erectile dysfunction as it can be seen in
Fig. 5, our experience is discordant with the other series, and since then, we
see that as urinary discomfort improve over time and mostly disappear within
one year, erectile dysfunction progressively worsens in the first 5 years31,35,42.
CONCLUSIONS
Our
experience over these seven years, with a wide casuistry, allow us to affirm
that with a good selection of candidates patients, the results are
satisfactory, both in biological control, as in overall survival. Furthermore,
the undeniable brachyterapy toxicity as in any type of radiation is minimized
and greatly relieved with precautions that even if they seem to be obvious are
not always taken into account; we refer to the prior functional study, the
non-rectal manipulation within a recommended period, and the use of hyaluronic
acid gel, among other measures that are effective.
Furthermore,
the flexible cystoscopy to verify the correct placement of the needle before
implant seems to us to be essential.
The
technique is very sophisticated, and we believe that with planning in real time
and the peripheral implant on the low risk stages, the result is equivalent to
surgery, but more years of follow-up will be needed to confirm these
impressions.
Although
as we say, the technological improvement is quite remarkable, probably in the
lower rate case has reached its ceiling and probably the future and development
will probably come with temporary high dose implants that together with new
protocols, low costs for the iridium power source, are directed to a treatment with
four high rate doses, obviating the additional external.
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Correspondence
author: Dr. J.Mª Abascal Junquera
Servicio de Urología.
Hospital Universitario Central de Asturias
Celestino Villamil,
s/n - 33006 Oviedo (Asturias)
Tel.: 985 108 004
Author e-mail: josuvargas@hotmail.com
Paper infrmation:
Original