1.
Introduction
Energy-based partial gland ablation is an emerging
treatment for localized intermediate-risk prostate cancer
(PCa) that aims to reduce the morbidity associated with
radical whole-gland therapy while delivering cancer control
[1,2]. These focal therapies are adapted to PCa location, such
as the peripheral zone (PZ), transition zone (TZ), or anterior
fibromuscular stroma (AFMS)
[3] .Use of magnetic resonance imaging (MRI) and targeted
biopsies has led to better detection and localization of PCa,
such as diagnosing anterior prostate cancers (APCs)
originating from the TZ. APCs account for 19% of new
cancers
[4–7]. We demonstrated that APCs originate from
the anterior and medial TZ as well as anterior to the urethra
in the midline
[8,9]. Probably due to benign prostatic
hyperplasia (BPH), some APCs spread anteriorly into the
AFMS; then the anterior limit of the TZ acts as a barrier to
APCs extending posteriorly
[4].
An APC nodule can occasionally be located mainly within
the AFMS and anterior to the TZ boundary without any
cancer in the PZ. In these highly selected cases, which
represent 3–5% of new cancers (Supplement 1), focal or
partial treatment is appealing. However, delivering thermal
energy to an apical APC may be undesirable
[3], for fear of
compromising the external sphincteric unit and/or the
neurovascular bundles.
In this specific circumstance, we believe that en bloc
surgical excision of the anterior prostate (ie, TZ, AFMS,
anterior part of the PZ) would preserve intact the
posterolateral aspect of the distal (submontanal) urethra,
PZ, and periprostatic tissues. Doing so would effectively
ablate the tumor with a safety margin of benign tissue
posteriorly, deliver superior continence/potency outcomes
versus radical prostatectomy (RP), and allow pathologic
assessment of excised tissue. PSA nadir would still
potentially be an accurate marker for oncologic control,
and a complementary RP or ablative therapy could be
performed in case of cancer recurrence, with oncologic and
functional outcomes similar to RP.
The objective of our study was to evaluate the feasibility
and oncologic and functional outcomes of robot-assisted
anterior partial prostatectomy (APP) for isolated MRI-
detected APC in a highly selected cohort.
2.
Patients and methods
2.1.
Study population
This study used a prospective single-arm single-center stage 2a
Innovation, Development, Exploration, Assessment, Long-term (IDEAL)
paradigm
[10]. The robot-assisted APP technique innovation was carried
out by a few surgeons, deemed to be probably safe after the first five
cases, and was tested more broadly, although still experimental, in well-
selected patients. The intervention needed to be refined. A regulatory
process was required at this stage, and the study was approved by the
institutional review board at the University of Lille, France, where all
cases were treated. After detailed information was given to the patients,
written signed consent was obtained. Assessing safety for the first five
cases was based on bleeding (no transfusion), functional results at 6 mo
(International Continence Society [ICS] score 4), and oncologic results
(at least two of three cases with negative lateral/posterior margins).
After five consecutive surgeries in an 18-mo period, the investigators
decided to pursue the study. The decision to analyze the results after
17 patients was established empirically (median follow-up
>
24 mo was
reached).
Inclusion criteria comprised a multiparametric MRI (mpMRI)–
identified, predominantly anteriorly located tumor. It was proven at
targeted biopsy (two cores per lesion) and determined to be at low or
intermediate risk
[11,12]. Cancer could be of any volume at MRI,
provided its posterior limits were at least 17 mm (posterior biopsy core
length) anterior to the rectal surface of the gland that defines the anterior
location of cancers, and its lateral limits were within the TZ or AFMS. The
whole prostate gland could be of any volume
[13]. Exclusion criteria
were if the posterior aspect of the APC at MRI was located
<
5 mm
anterior to a coronal plane located at the level of the posterior TZ
boundary
( Fig. 1 )or MRI-targeted biopsies Gleason score (GS)
>
7, an
anterior bulging of the tumor beyond prostate boundaries or extension
in the preprostatic fat or bladder neck (BN), a cancer length
>
3 mm at
12 systematic posterior biopsies in an adjacent sector to the anterior
cancer, or an additional clinically significant PZ cancer (
>
3 mm of cancer
on one core at 12 systematic posterior biopsies or at MRI-targeted
biopsies to an secondary posteriorly located lesion at MRI). Patients who
refused to consent were offered RP, radiation therapy, and/or active
surveillance. Over an 8-yr period (January 2008 to December 2015),
28 patients fulfilled the entry criteria, of whom 17 (60%) gave informed
consent and were enrolled in the study.
All patients underwent prebiopsy mpMRI, followed by MR-targeted
biopsies to any visible lesion, plus a 12-core systematic transrectal
ultrasound–guided biopsy. Self-administered validated quality-of-life
(QOL) questionnaires were used to assess preoperative urinary function
(International Prostate Symptom Score [IPSS]), continence (ICS: 1–2),
and potency (International Index of Erectile Function [IIEF]-5). Potency
was defined as an IIEF-5 score 20 with or without drugs. Preoperative
mpMRI protocol was performed within 3 mo of surgery and included
axial (and sagittal, if necessary) gadolinium-enhanced sequences to
assess the contour and the craniocaudal extent of the biopsy-proven
cancerous area
[8].
2.2.
Surgical technique
Robotic surgery consisted of en bloc excision of the anterior part of the
prostate composed of the AFMS, BN, prostate adenoma (TZ and median
lobe) along with the proximal prostate urethra, PZ apical anterior horns,
anterior aspect of the distal (submontanal) urethra, and anterior BN
(Supplement 1, Fig. 1). Only three cases had lymph node dissection due
to suspicious enlarged pelvic node enlargement at MRI (
n
= 2) and GS 4 +
3 (
n
= 1).
Perioperative data including peri- and postoperative treatment-
related adverse events, and time to bladder catheter removal were
recorded. Cancer location, volume, and margins were assessed according
to the Stanford technique
[14]. We differentiated positive posterior
surgical margins at the posterior aspect of the excised specimen from
anterior surgical margins that are an artifact occurring when prepro-
static fat is removed during exposure in patients with APC. Patients with
a positive posterior margin underwent mpMRI and biopsy of the PZ
within 3 mo after surgery. We recommended that patients with a
positive biopsy have a robot-assisted salvage nerve-sparing RP
(Supplement 1).
All patients underwent PSA monitoring at 3 and 6 mo and then every
6 mo and had mpMRI at 6–12 mo. At 6 mo, protocol-based 12-core and/
or targeted biopsies were performed in the first seven patients. Because
biopsies were negative when MRI was not suspicious, only for-cause
biopsies were performed in the remaining 10 patients. Self-administered
E U R O P E A N U R O L O G Y 7 2 ( 2 0 1 7 ) 3 3 3 – 3 4 2
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