Objective
To evaluate the efficacy of the balloon spacer when used to reduce the radiation dose delivered to the rectum in prostate cancer patients undergoing external beam radiotherapy.
Method
A single center retrospective analysis including 75 PC patients with localized T1-T3a disease who received balloon spacer followed by EBRT. Pre- and post-implantation computed tomography (CT) scans were utilized for treatment planning for standard EBRT (78–81 Gy in 1.8–2 Gy fractions). Rectal dosimetry was assessed using DVHs, and toxicities were graded with CTCAE v.4.
Results
A median (IQR) prostate-rectum separation resulted in 1.6 cm (1.4–2.0) post balloon spacer implantation. Overall, 90.6 % (68/75) of patients had a clinically significant 25 % relative reduction in the rectal with a median relative reduction of 91.8 % (71.2–98.6 %) at rV70. Three (4.0 %) patients reported mild procedural adverse events, anal discomfort and dysuria. Within 90 days post-implantation, five patients (6.67 %) and 1 patient (1.33 %) reported grade 1 and grade 2 rectal toxicities (anal pain, constipation, diarrhea and hemorrhoids). Genitourinary (GU) grade 1 toxicity was reported in 37 patients (49.33 %), with only one patient (1.33 %) experiencing grade 2 GU toxicity. No grade ≥ 3 toxicity was reported.
Conclusion
Balloon spacer implantation effectively increased prostate-rectum separation and associated with dosimetric gains EBRT for PC stage T1-T3a. Further controlled studies are required to ascertain whether this spacer allows for radiotherapy dose escalation and minimizes gastrointestinal (GI) toxicity.