Clinical trial NCT03493997: Multicentre International STudy for the Prevention With Ialuril® of Radio-induced Cystitis (MISTIC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Study Group for Urogenital Diseases, Italy
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients
timeFrame: 12 months
Secondary outcomes:
measure: comparative analysis of score between the two groups through ICIQ
timeFrame: 12 months
measure: comparative analysis of score between the two groups through EPIC
timeFrame: 12 months
measure: comparative analysis of score of QOL
timeFrame: 12 months
measure: comparative analysis of score between the two groups through IPSS
timeFrame: 12 months
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Ospedali Careggi
city: Milano
country: Italy
facility: Università "Vita-Salute" San Raffaele
city: Palermo
country: Italy
facility: University of Palermo, Italy
city: Bratislava
country: Slovakia
facility: St. Cyril and Method University Hospital
city: Prešov
country: Slovakia
facility: Fakultná nemocnica s poliklinikou
city: Barcelona
country: Spain
facility: Universidad Autónoma de Barcelona
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Gruppo di Studio per le Malattie Urogenitali
name: Massimo LAzzeri, MD
role: STUDY_DIRECTOR
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