Initial clinical experience with RADA16 as a novel therapeutic for severe haemorrhagic radiation cystitis: a preliminary feasibility case series.

BACKGROUND

Haemorrhagic radiation cystitis (HRC) is a challenging complication of pelvic radiotherapy, often resistant to conventional treatments.

AIMS: To evaluate the clinical efficacy and safety of RADA16, a self-assembling peptide, in managing severe HRC.

METHODS

A preliminary feasibility case series of five consecutive patients treated at two UK hospitals. All patients had persistent haematuria despite standard interventions and received RADA16 via flexible or rigid cystoscopy.

RESULTS

The findings from the cases suggest that all patients have experienced at least a partial or early resolution of haematuria and no adverse effects were reported. In most cases, two applications of RADA16 were sufficient. The longest patient followed up was still symptom free at 3 years.

DISCUSSION: This preliminary feasibility case series has demonstrated early efficacy for RADA16 in the management of HRC.

CONCLUSIONS

RADA16 is a potentially promising minimally invasive treatment for refractory HRC. Further trials are warranted to confirm these findings.