A Phase 2 interventional study of Radiotherapy+IAluril®+Ialuril Soft Gels® and Radiotherapy only in Prostate Cancer, sponsored by Study Group for Urogenital Diseases, Italy. Completed at 7 sites in 4 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-23.
Sponsored by Study Group for Urogenital Diseases, Italy · Phase 2, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Radiotherapy+Ialuril®+Ialuril Soft Gels®
Combination Product: Radiotherapy+IAluril®+Ialuril Soft Gels®
Radiotherapy only
Radiation: Radiotherapy only
Radiotherapy+IAluril®+Ialuril Soft Gels®
Radiotherapy only
Rate of patients
The rate of patients who stopped treatment with intravesical or oral Ialuril due to intollerance or adverse events
Time frame: 12 months
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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 12 months
Plan to share: No
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Study Group for Urogenital Diseases, Italy