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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Radiotherapy+IAluril®+Ialuril Soft Gels®
Radiotherapy only
Sponsored by
Study Group for Urogenital Diseases, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedali Careggi
  • Università "Vita-Salute" San Raffaele
  • University of Palermo, Italy
  • St. Cyril and Method University Hospital
  • Fakultná nemocnica s poliklinikou
  • Universidad Autónoma de Barcelona
  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radiotherapy+Ialuril®+Ialuril Soft Gels®

Radiotherapy only

Arm Description

Radiotherapy+Ialuril®+Ialuril Soft Gels®

Radiotherapy only

Outcomes

Primary Outcome Measures

Rate of patients
The rate of patients who stopped treatment with intravesical or oral Ialuril due to intollerance or adverse events

Secondary Outcome Measures

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
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)
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
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)

Full Information

First Posted
January 25, 2018
Last Updated
July 22, 2020
Sponsor
Study Group for Urogenital Diseases, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03493997
Brief Title
Multicentre International STudy for the Prevention With Ialuril® of Radio-induced Cystitis (MISTIC)
Acronym
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Study Group for Urogenital Diseases, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy+Ialuril®+Ialuril Soft Gels®
Arm Type
Experimental
Arm Description
Radiotherapy+Ialuril®+Ialuril Soft Gels®
Arm Title
Radiotherapy only
Arm Type
Active Comparator
Arm Description
Radiotherapy only
Intervention Type
Combination Product
Intervention Name(s)
Radiotherapy+IAluril®+Ialuril Soft Gels®
Intervention Description
Radiotherapy+IAluril®+Ialuril Soft Gels®
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy only
Intervention Description
Radiotherapy only
Primary Outcome Measure Information:
Title
Rate of patients
Description
The rate of patients who stopped treatment with intravesical or oral Ialuril due to intollerance or adverse events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
comparative analysis of score between the two groups through ICIQ
Description
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
Time Frame
12 months
Title
comparative analysis of score between the two groups through EPIC
Description
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)
Time Frame
12 months
Title
comparative analysis of score of QOL
Description
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
Time Frame
12 months
Title
comparative analysis of score between the two groups through IPSS
Description
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)
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo LAzzeri, MD
Organizational Affiliation
Gruppo di Studio per le Malattie Urogenitali
Official's Role
Study Director
Facility Information:
Facility Name
Ospedali Careggi
City
Firenze
Country
Italy
Facility Name
Università "Vita-Salute" San Raffaele
City
Milano
Country
Italy
Facility Name
University of Palermo, Italy
City
Palermo
Country
Italy
Facility Name
St. Cyril and Method University Hospital
City
Bratislava
Country
Slovakia
Facility Name
Fakultná nemocnica s poliklinikou
City
Prešov
Country
Slovakia
Facility Name
Universidad Autónoma de Barcelona
City
Barcelona
Country
Spain
Facility Name
Istanbul University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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Multicentre International STudy for the Prevention With Ialuril® of Radio-induced Cystitis (MISTIC)

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