Multicentre International STudy for the Prevention With Ialuril® of Radio-induced Cystitis (MISTIC)

The study is randomized and it will be conducted in the field of routine clinical practice. A total of 100 consecutive patients planned to receive radiotherapy for prostate cancer will be enrolled. The patients will enter the study as controls (50 patients that won't receive any experimental IMP) or as treated-group (50 patients that will be also treated with the experimental IMPs, Ialuril® and Ialuril® Soft Gels) according to a predefined, centre-specific randomization.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

* Male patients planned to receive primary radiotherapy for prostate cancer.

Exclusion Criteria:

* Female patients
* Patients with a life expectancy of less than 24 months
* with radiological confirmed metastasis
* with documented urethral strictures
* undergoing chemotherapy
* who received brachytherapy
* who received chemo-radiotherapy for prostate cancer in the past
* previously treated with Bacillus Calmette-Guerin (BCG)
* with post-void residual (PVR) \> 200ml
* with clinical evidence of bladder calculi
* with neurogenic bladder or neurologic disease at risk for neurogenic bladder
* suffering from any lower urinary infections (UTIs, tuberculosis)
* with unstable cardiovascular disease
* with Congestive Heart Failure (CHF)
* with current nitrate use
* with current anticoagulants use (i.e. warfarin, heparin, etc.)
* with clinically significant hepatobiliary or renal disease
* with history of significant CNS injuries within 6 months
* with any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

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