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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Combination Product: Radiotherapy+IAluril®+Ialuril Soft Gels®
* Radiation: Radiotherapy only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy+Ialuril®+Ialuril Soft Gels®<br>Radiotherapy+Ialuril®+Ialuril Soft Gels® | Combination Product: Radiotherapy+IAluril®+Ialuril Soft Gels®<br>* Radiotherapy+IAluril®+Ialuril Soft Gels®<br>|
| Active Comparator: Radiotherapy only<br>Radiotherapy only | Radiation: Radiotherapy only<br>* Radiotherapy only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients | The rate of patients who stopped treatment with intravesical or oral Ialuril due to intollerance or adverse events | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparative analysis of score between the two groups through ICIQ | comparative analysis of score between the two groups (active arm vs. no drug arm)following questionnaires scores. Questionnaires: • ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) questionnaire and bladder diary - Scale: Never - Occasionally Sometimes - Most of the time - All of the time | 12 months | 
| comparative analysis of score between the two groups through EPIC | comparative analysis of score between the two groups (active arm vs. no drug arm)following questionnaires scores. Expanded Prostate Cancer Index Composite (EPIC) - Urinary Domain Scale :From 1 to 5 ( 1 smallest, 5 highest) | 12 months | 
| comparative analysis of score of QOL | comparative analysis of score between the two groups (active arm vs. no drug arm)following questionnaires scores. EQ-5D-5L (QoL) - Scale: I am not anxious or depressed I am slightly anxious or depressed I am moderately anxious or depressed I am severely anxious or depressed I am extremely anxious or depressed | 12 months | 
| comparative analysis of score between the two groups through IPSS | comparative analysis of score between the two groups (active arm vs. no drug arm)following questionnaires scores. IPSS Scale: 0 to 5 (0 worst - 5 best) | 12 months |