INTRODUCTION: Thanks to technological improvements and the recent radiobiological

data, extreme hypofractionated RT by means of Stereotactic body RT techniques

(SBRT) has been introduced in the last years as a potential treatment option for
selected prostate cancer patients. End point of the present report is to assess
feasibility and rectal preliminary tolerability of SBRT in prostate cancer patients with
gel spacer injection (SPACEOARTM).
MATERIALS AND METHODS: between November 2013 and November 2014, 10
patients were selected and recruited in a treatment protocol of SBRT with radical
intent using a gel spacer injection (SPACEOAR TM) between prostate and rectum.
Inclusion criteria were PSA 20 ng/ml, histologically proven prostate adenocarcinoma, T1-T2
stage, no distant metastases, no previous surgery other than TURP, IPSS 07. The schedule was
35 Gy in 5 days. SBRT was delivered with RapidArc VMAT, with 10MV FFF photons. Toxicity
assessment was performed according to CTCAE v4.0 scale. EPIC questionnaires assessed
Quality-of-Life. Neo-adjuvant/concomitant hormonal-therapy was prescribed according to risk
classification. SpaceOAR gel was implanted by the urologist with rectal ultra sound guide and
with transperineal needle injection to increase the separation space between the prostate and
the anterior rectal wall. MRI was performed 7-10 days after injection; MRI(T2)/CT image fusion
was used to define the gel spacer placement during treatment planning. Regarding the
distance between posterior part of prostate and anterior rectal wall after gel injection, a
measure of spacer dimension was performed in each CT/MRI slide of each patient, in axial and
sagittal view.
RESULTS: After the gel injection, a median distance of 1.25 cm(0.50-1.63) in axial view

and 1.26 cm (0.53-1.67) were found in the population of study. Only in 2 out of 10
cases, a distance inferior than 1 cm was measured. All patients finished the treatment
with a minimum FUP of 60 days after the end of the treatment.

Acute rectal toxicity was

recorded as follow: 2 patients experienced rectal G1 toxicity (tenesmus), one patient complain
G2 rectal pain needing drugs. In 7 cases no rectal toxicity was documented within 3 months.

CONCLUSIONS: Spacer Gel was able to increase the minimum distance between rectum and
prostate of more than 1 cm in 8/10 cases and no rectal toxicity(any grade) was found in 7/10
cases. Although more mature results are needed, early findings suggest that SBRT with
RapidArc and FFF beams for prostate cancer in 5 fractions with SpaceOAR gel injection is
feasible and well tolerated in rectal acute setting. Longer follow-up is needed for assessment of
late rectal toxicity and outcome.