NCT03493997

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Apr 2017

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

January 25, 2018

Last Update Submit

July 22, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of patients

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

    12 months

Secondary Outcomes (4)

  • comparative analysis of score between the two groups through ICIQ

    12 months

  • comparative analysis of score between the two groups through EPIC

    12 months

  • comparative analysis of score of QOL

    12 months

  • comparative analysis of score between the two groups through IPSS

    12 months

Study Arms (2)

Radiotherapy+Ialuril®+Ialuril Soft Gels®

EXPERIMENTAL

Radiotherapy+Ialuril®+Ialuril Soft Gels®

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

Radiotherapy only

ACTIVE COMPARATOR

Radiotherapy only

Radiation: Radiotherapy only

Interventions

Radiotherapy+IAluril®+Ialuril Soft Gels®COMBINATION_PRODUCT

Radiotherapy+IAluril®+Ialuril Soft Gels®

Radiotherapy+Ialuril®+Ialuril Soft Gels®
Radiotherapy onlyRADIATION

Radiotherapy only

Radiotherapy only

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients planned to receive primary radiotherapy for prostate cancer.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ospedali Careggi

Florence, Italy

Location

Università "Vita-Salute" San Raffaele

Milan, Italy

Location

University of Palermo, Italy

Palermo, Italy

Location

St. Cyril and Method University Hospital

Bratislava, Slovakia

Location

Fakultná nemocnica s poliklinikou

Prešov, Slovakia

Location

Universidad Autónoma de Barcelona

Barcelona, Spain

Location

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (19)

  • 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.

    PMID: 18495016BACKGROUND

  • Pavlidakey 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.

    PMID: 19625037BACKGROUND

  • Smit 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.

    PMID: 20212517BACKGROUND

  • Antonakopoulos 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.

    PMID: 6737117BACKGROUND

  • Denham 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.

    PMID: 12063002BACKGROUND

  • Hurst 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.

    PMID: 8012413BACKGROUND

  • Lazzeri 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.

    PMID: 21474233BACKGROUND

  • Damiano 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.

    PMID: 21272992BACKGROUND

  • De 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.

    PMID: 22614285BACKGROUND

  • Cervigni M, Sommariva M, Porru D, Ostardo E, Tenaglia R, Giammò A, et al. A randomized, open-label, multicentre study of efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate (HA 1.6% and CS 2%) vs dimethyl sulfoxide (DMSO 50%) in women with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC). Eur Urol Suppl 2014;13(1):e464.

    BACKGROUND

  • Cervigni 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.

    BACKGROUND

  • Nordling J. Bladder Pain Syndrome/ Interstitial Cystitis. Update in Europe. International Journal of Urology 2014;21(Supplement S1):A1-A11.

    BACKGROUND

  • Crew JP, Jephcott CR, Reynard JM. Radiation-induced haemorrhagic cystitis. Eur Urol. 2001 Aug;40(2):111-23. doi: 10.1159/000049760.

    PMID: 11528186BACKGROUND

  • Cox 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.

    PMID: 7713792BACKGROUND

  • Charlson 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.

    PMID: 7722560BACKGROUND

  • Droller MJ, Saral R, Santos G. Prevention of cyclophosphamide-induced hemorrhagic cystitis. Urology. 1982 Sep;20(3):256-8. doi: 10.1016/0090-4295(82)90633-1.

    PMID: 7123717BACKGROUND

  • Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905. doi: 10.1016/s0090-4295(00)00858-x.

    PMID: 11113727BACKGROUND

  • Hamilton K, Bennett NC, Purdie G, Herst PM. Standardized cranberry capsules for radiation cystitis in prostate cancer patients in New Zealand: a randomized double blinded, placebo controlled pilot study. Support Care Cancer. 2015 Jan;23(1):95-102. doi: 10.1007/s00520-014-2335-8. Epub 2014 Jul 4.

    PMID: 24993395BACKGROUND

  • Mottet N, Bastian PJ, Bellmunt J, van den Bergh RCN, Bolla M, van Casteren NJ, et al. Guidelines on Prostate Cancer. Uroweb 2014.

    BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Massimo LAzzeri, MD

    Gruppo di Studio per le Malattie Urogenitali

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2018

First Posted

April 11, 2018

Study Start

April 4, 2017

Primary Completion

October 31, 2018

Study Completion

May 31, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

SL(2)ES(1)IT(3)TU(1)