Prostate CancerPhase 2MISTICNCT03493997
Multicentre International STudy for the Prevention With Ialuril® of Radio-induced Cystitis (MISTIC)
A Phase 2 study testing Radiotherapy+IAluril®+Ialuril Soft Gels® and Radiotherapy only in people with Prostate Cancer, run by Study Group for Urogenital Diseases, Italy at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiotherapy+IAluril®+Ialuril Soft Gels® and Radiotherapy only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 4 Apr 2017to 31 May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients planned to receive primary radiotherapy for prostate cancer.
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Italy3 sites
Ospedali Careggi
Florence
Università "Vita-Salute" San Raffaele
Milan
University of Palermo, Italy
Palermo
Slovakia2 sites
St. Cyril and Method University Hospital
Bratislava
Fakultná nemocnica s poliklinikou
Prešov
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Radiotherapy+IAluril®+Ialuril Soft Gels®, Radiotherapy only
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy+IAluril®+Ialuril Soft Gels®Combination product
Radiotherapy+IAluril®+Ialuril Soft Gels®
Radiotherapy onlyRadiation
Radiotherapy only
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy+Ialuril®+Ialuril Soft Gels® | Experimental | Radiotherapy+Ialuril®+Ialuril Soft Gels® Receives: Combination Product: Radiotherapy+IAluril®+Ialuril Soft Gels® |
| Radiotherapy only | Active comparator | Radiotherapy only Receives: Radiation: Radiotherapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients
The rate of patients who stopped treatment with intravesical or oral Ialuril due to intollerance or adverse events
Measured: 12 months
Secondary outcomes (4)
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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start4 Apr 2017
- Primary completion31 Oct 2018
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Study Group for Urogenital Diseases, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo LAzzeri, MD, Study director, Gruppo di Studio per le Malattie Urogenitali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493997
- Sponsor's protocol ID
- MISTIC
- Acronym
- MISTIC
- Status last verified
- Jul 2020
- First submitted
- 25 Jan 2018
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lips IM, Dehnad H, van Gils CH, Boeken Kruger AE, van der Heide UA, van Vulpen M. High-dose intensity-modulated radiotherapy for prostate cancer using daily fiducial marker-based position verification: acute and late toxicity in 331 patients. Radiat Oncol. 2008 May 21;3:15. doi: 10.1186/1748-717X-3-15.
PubMed 18495016Pavlidakey PG, MacLennan GT. Radiation cystitis. J Urol. 2009 Sep;182(3):1172-3. doi: 10.1016/j.juro.2009.06.034. Epub 2009 Jul 22. No abstract available.
PubMed 19625037Smit SG, Heyns CF. Management of radiation cystitis. Nat Rev Urol. 2010 Apr;7(4):206-14. doi: 10.1038/nrurol.2010.23. Epub 2010 Mar 9.
PubMed 20212517Antonakopoulos GN, Hicks RM, Berry RJ. The subcellular basis of damage to the human urinary bladder induced by irradiation. J Pathol. 1984 Jun;143(2):103-16. doi: 10.1002/path.1711430205.
PubMed 6737117Denham JW, Hauer-Jensen M. The radiotherapeutic injury--a complex 'wound'. Radiother Oncol. 2002 May;63(2):129-45. doi: 10.1016/s0167-8140(02)00060-9.
PubMed 12063002Hurst RE. Structure, function, and pathology of proteoglycans and glycosaminoglycans in the urinary tract. World J Urol. 1994;12(1):3-10. doi: 10.1007/BF00182044.
PubMed 8012413Lazzeri M, Montorsi F. The therapeutic challenge of "chronic cystitis": search well, work together, and gain results. Eur Urol. 2011 Jul;60(1):78-80. doi: 10.1016/j.eururo.2011.03.039. Epub 2011 Apr 1. No abstract available.
PubMed 21474233Damiano R, Quarto G, Bava I, Ucciero G, De Domenico R, Palumbo MI, Autorino R. Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial. Eur Urol. 2011 Apr;59(4):645-51. doi: 10.1016/j.eururo.2010.12.039. Epub 2011 Jan 18.
PubMed 21272992De Vita D, Giordano S. Effectiveness of intravesical hyaluronic acid/chondroitin sulfate in recurrent bacterial cystitis: a randomized study. Int Urogynecol J. 2012 Dec;23(12):1707-13. doi: 10.1007/s00192-012-1794-z. Epub 2012 May 22.
PubMed 22614285Cervigni M, Sommariva M, Tenaglia R, Porru D, Ostardo E, Giammo A, Trevisan S, Frangione V, Ciani O, Tarricone R, Pappagallo GL. A randomized, open-label, multicenter study of the efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate versus dimethyl sulfoxide in women with bladder pain syndrome/interstitial cystitis. Neurourol Urodyn. 2017 Apr;36(4):1178-1186. doi: 10.1002/nau.23091. Epub 2016 Sep 21.
PubMed 27654012Cervigni M, Van Kerrebroeck PE, Dinis Oliveira P, Tarricone R, Guzman SA. Glycosaminoglycan-Replenishment Therapy: rationale for use and current evidence. EMJ Urol. 2014;1:41-47.
Nordling J. Bladder Pain Syndrome/ Interstitial Cystitis. Update in Europe. International Journal of Urology 2014;21(Supplement S1):A1-A11.
Crew JP, Jephcott CR, Reynard JM. Radiation-induced haemorrhagic cystitis. Eur Urol. 2001 Aug;40(2):111-23. doi: 10.1159/000049760.
PubMed 11528186Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available.
PubMed 7713792Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. doi: 10.1016/0895-4356(94)90129-5.
PubMed 7722560
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03493997
- Acronym / sponsor ID
- MISTIC / MISTIC
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Study Group for Urogenital Diseases, ItalyUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy+Ialuril®+Ialuril Soft Gels® | Experimental | Combination Product: Radiotherapy+IAluril®+Ialuril Soft Gels®Radiotherapy+Ialuril®+Ialuril Soft Gels® |
| Radiotherapy only | Active comparator | Radiation: Radiotherapy onlyRadiotherapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients planned to receive primary radiotherapy for prostate cancer.
Key exclusion criteria (19 listed)
- Female patients
- Patients with a life expectancy of less than 24 months
- with radiological confirmed metastasis
- with documented urethral strictures
- undergoing chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy+IAluril®+Ialuril Soft Gels®Radiotherapy+IAluril®+Ialuril Soft Gels® | Combination product | Radiotherapy+Ialuril®+Ialuril Soft Gels® |
| Radiotherapy onlyRadiotherapy only | Radiation | Radiotherapy only |
Primary outcome
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
4 secondary outcomes
comparative analysis of score between the two groups through ICIQ
Time frame: 12 months
comparative analysis of score between the two groups through EPIC
Time frame: 12 months
comparative analysis of score of QOL
Time frame: 12 months
comparative analysis of score between the two groups through IPSS
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Background: PubMed 18495016Lips IM, Dehnad H, van Gils CH, Boeken Kruger AE, van der Heide UA, van Vulpen M. High-dose intensity-modulated radiotherapy for prostate cancer using daily fiducial marker-based position verification: acute and late toxicity in 331 patients. Radiat Oncol. 2008 May 21;3:15. doi: 10.1186/1748-717X-3-15.
- Background: PubMed 19625037Pavlidakey PG, MacLennan GT. Radiation cystitis. J Urol. 2009 Sep;182(3):1172-3. doi: 10.1016/j.juro.2009.06.034. Epub 2009 Jul 22. No abstract available.
- Background: PubMed 20212517Smit SG, Heyns CF. Management of radiation cystitis. Nat Rev Urol. 2010 Apr;7(4):206-14. doi: 10.1038/nrurol.2010.23. Epub 2010 Mar 9.
- Background: PubMed 6737117Antonakopoulos GN, Hicks RM, Berry RJ. The subcellular basis of damage to the human urinary bladder induced by irradiation. J Pathol. 1984 Jun;143(2):103-16. doi: 10.1002/path.1711430205.
- Background: PubMed 12063002Denham JW, Hauer-Jensen M. The radiotherapeutic injury--a complex 'wound'. Radiother Oncol. 2002 May;63(2):129-45. doi: 10.1016/s0167-8140(02)00060-9.
- Background: PubMed 8012413Hurst RE. Structure, function, and pathology of proteoglycans and glycosaminoglycans in the urinary tract. World J Urol. 1994;12(1):3-10. doi: 10.1007/BF00182044.
- Background: PubMed 21474233Lazzeri M, Montorsi F. The therapeutic challenge of "chronic cystitis": search well, work together, and gain results. Eur Urol. 2011 Jul;60(1):78-80. doi: 10.1016/j.eururo.2011.03.039. Epub 2011 Apr 1. No abstract available.
- Background: PubMed 21272992Damiano R, Quarto G, Bava I, Ucciero G, De Domenico R, Palumbo MI, Autorino R. Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial. Eur Urol. 2011 Apr;59(4):645-51. doi: 10.1016/j.eururo.2010.12.039. Epub 2011 Jan 18.
- Background: PubMed 22614285De Vita D, Giordano S. Effectiveness of intravesical hyaluronic acid/chondroitin sulfate in recurrent bacterial cystitis: a randomized study. Int Urogynecol J. 2012 Dec;23(12):1707-13. doi: 10.1007/s00192-012-1794-z. Epub 2012 May 22.
- Background: PubMed 27654012Cervigni M, Sommariva M, Tenaglia R, Porru D, Ostardo E, Giammo A, Trevisan S, Frangione V, Ciani O, Tarricone R, Pappagallo GL. A randomized, open-label, multicenter study of the efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate versus dimethyl sulfoxide in women with bladder pain syndrome/interstitial cystitis. Neurourol Urodyn. 2017 Apr;36(4):1178-1186. doi: 10.1002/nau.23091. Epub 2016 Sep 21.
- BackgroundCervigni M, Van Kerrebroeck PE, Dinis Oliveira P, Tarricone R, Guzman SA. Glycosaminoglycan-Replenishment Therapy: rationale for use and current evidence. EMJ Urol. 2014;1:41-47.
- BackgroundNordling J. Bladder Pain Syndrome/ Interstitial Cystitis. Update in Europe. International Journal of Urology 2014;21(Supplement S1):A1-A11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo LAzzeri, MD study director
Gruppo di Studio per le Malattie Urogenitali
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy+IAluril®+Ialuril Soft Gels® and Radiotherapy only in people with Prostate Cancer, run by Study Group for Urogenital Diseases, Italy at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Slovakia, Spain, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03493997, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.