9 / 96
P
rostate
cancer
– T
herapy
with
radium
-223
R
ev
A
ssoc
M
ed
B
ras
2017; 63(12):1019-1023
1019
GUIDELINES IN FOCUS
Prostate cancer – Therapy with radium-223
C
âncer
de
próstata
– T
erapia
com
rádio
-223
Authorship:
Brazilian Society of Nuclear Medicine
Participants:
Ana Emília Brito
1
, Bárbara Juarez Amorim
2
, Milena Martello
3
,
Wanderley Marques Bernardo
3
, Elba Etchebehere
4
Final draft:
December 11, 2017
1
MD Real Nuclear – Real Hospital Português de Pernambuco, Recife, PE, Brazil
2
MD, PhD Professor. Department of Nuclear Medicine, Hospital de Clínicas da Universidade Estadual de Campinas (Unicamp). Scientific Director of the Brazilian Society of Nuclear Medicine, Campinas, SP, Brazil
3
AMB Guidelines Program
4
MD, PhD Professor. Department of Nuclear Medicine, Hospital de Clínicas da Unicamp. MND Director, Campinas – MND Group, Campinas, SP, Brazil
http://dx.doi.org/10.1590/1806-9282.63.12.1019The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize
procedures to assist the reasoning and decision-making of doctors.
The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending
on the conditions and the clinical status of each patient.
D
escription
of
the
evidence
collection method
This guideline followed the standard of a systematic
review with evidence retrieval based on evidence-based
medicine (EBM), so that clinical experience is integrated
with the ability to critically analyze and apply scientific
information rationally, thus improving the quality of
medical care.
We used the structured mode of formulating questions
synthesized by the acronym PICO, where P stands for pa-
tients with prostate cancer, I stands for indicator, i.e., ra-
dium-223, and O stands for outcome, which is benefit.
Based on the structured question, we identified the
descriptors that formed the basis of the search for evidence
in the databases: Medline-Pubmed. Ninety-nine (99) stud-
ies were retrieved and, after applying the eligibility criteria
(inclusion and exclusion), 13 were selected to answer the
clinical question (Annex I).
C
linical
question
What is the benefit of radium-223 therapy in prostate cancer?
G
rades
of
recommendation
and
levels
of
evidence
•
•
A: Experimental or observational studies of higher
consistency.
•
•
B: Experimental or observational studies of lower
consistency.
•
•
C: Cases reports / non-controlled studies.
•
•
D: Opinion without critical evaluation, based on con-
sensus, physiological studies or animal models.
O
bjective
The aim of this guideline is to estimate the benefit of ra-
dium-223 chloride therapy (Ra223) in patients with pros-
tate cancer resistant to castration and bone metastases.
I
ntroduction
Ra223 has been approved by the Brazilian Health Surveil-
lance Agency (Anvisa) to be used as a drug in the treatment
of patients with bone metastases from metastatic castra-
tion-resistant prostate cancer (mCRPC) without known
visceral metastases.
1
This treatment is indicated when patients with
mCRPC have blastic bone metastases in an attempt to
increase survival, but it is also applied in these condi-
tions when patients have symptoms, such as pain (but
not exclusively).
Ra223 is a low-range (< 100 μm), high-energy (27.4
MeV) alpha particle emitter, similar to calcium, which is
directed to areas where bone remodeling is increased,
which occurs in sclerotic bone metastases of prostate
cancer. The high energy of alpha particles causes the DNA
to break down in the metastatic cells (cytotoxic effect),
with low damage in the adjacent cells due to their low
reach (< 10 cells).
2