Prostate Cancer Clinical Trial
Official title:
An Investigative, Randomized, Open, Pilot Study to Assess the Tolerability, Safety and Efficacy of HAcid/CS Intravesical Instillations Plus an Oral Combination of Curcumin,Quercetin, HA and CS in Prevention of Radiation Induced Cystitis
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.
Radiotherapy will last for 6 weeks. During planning of treatment, regimen and average dose to
the whole bladder will be recorded to assess the impact of EBRT on urinary symptoms.
The treated-group will receive also intravesical Ialuril® weekly for 6 weeks (in the 24 hours
before every radiation therapy weekly schedule), plus oral treatment with Ialuril® Soft Gels
capsules (1 capsule twice a day after meals, at a distance of 12 hours, for 12 weeks).
The control-group will receive radiotherapy only for 6 weeks.
The Primary Objective is to assess the tolerability and safety of HA-CS intravesical
instillations (Ialuril®) plus an oral combination of curcumin, quercetin, HA and CS (Ialuril®
Soft Gels) in male patients undergoing radiotherapy for prostate cancer The efficacy of the
treatment will be evaluated at the end of the study once received all the crfs.
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