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NCT Number: NCT03493997

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Ospedali Careggi, Florence, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy+IAluril®+Ialuril Soft Gels®

Combination Product

Radiotherapy+IAluril®+Ialuril Soft Gels®

Radiotherapy only

Radiation

Radiotherapy only

Primary outcomes

  1. Rate of patients

    Time frame: 12 months

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

Secondary outcomes

  1. comparative analysis of score between the two groups through ICIQ

    Time frame: 12 months

    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

  2. comparative analysis of score between the two groups through EPIC

    Time frame: 12 months

    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)

  3. comparative analysis of score of QOL

    Time frame: 12 months

    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

  4. comparative analysis of score between the two groups through IPSS

    Time frame: 12 months

    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)

Sponsors and collaborators

Lead sponsor

Study Group for Urogenital Diseases, Italy

Other

Registry information

Official study 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

Acronym: MISTIC

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Apr 11, 2018
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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