Transperineal Injection of Cross-linked Hyaluronan Gel Into Anterior Perirectal Fat to Reduce Rectal Toxicity From High Dose Rate Brachytherapy and/or Intensity-Modulated Radiation Therapy for Prostate Cancer
The main risk associated with transperineal injection of cross-linked hyaluronan gel into
the anterior perirectal fat is infection. Prophylactic antibiotics will be given, resulting
in a <5% risk. Another possible risk (<5%) is an allergic reaction such as itching.
Patients who are allergic to avian products will be excluded from the study. Tenderness and
pain at the injection site are possible. Bleeding, bruising, redness, or discoloration or
the formation of a bump (granuloma) or scar (keloid) at the injection site is also possible.
Embolization of cross-linked hyaluronan gel through the blood is a potential, rare
complication if the gel is injected into a blood vessel rather than into fat. Prada et al.
did not see any side effects related to the injection or the material itself in 27 patients
based on a mean follow-up of 13 months (range: 9-22 months). Patients did not complain of
pain, tenesmus, rectal pressure, or a sensation of rectal filling. Risks beyond 22 months
are not well defined. Potential benefits of cross-linked hyaluronan gel include fewer
rectal complications due to radiotherapy for early-stage prostate cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mean rectal dose without Hylaform vs with Hylaform
Kenneth M Tokita, MD
Cancer Center of Irvine
United States: Food and Drug Administration
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