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

S

Study Group for Urogenital Diseases, Italy

Status and phase

Completed
Phase 2

Conditions

Prostate Cancer

Treatments

Combination Product: Radiotherapy+IAluril®+Ialuril Soft Gels®
Radiation: Radiotherapy only

Study type

Interventional

Funder types

Other

Identifiers

NCT03493997
MISTIC

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Radiotherapy+Ialuril®+Ialuril Soft Gels®
Experimental group
Description:
Radiotherapy+Ialuril®+Ialuril Soft Gels®
Treatment:
Combination Product: Radiotherapy+IAluril®+Ialuril Soft Gels®
Radiotherapy only
Active Comparator group
Description:
Radiotherapy only
Treatment:
Radiation: Radiotherapy only

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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