A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Prior to performing any study specific procedure (including screening procedures to determine eligibility), a signed consent form will be obtained for each subject. Patients will be enrolled in the study only if they meet all the inclusion criteria and none of the exclusion criteria. Prior to perform any study specific procedure (including screening procedures to determine eligibility), a signed informed consent form will be obtained for each subject. The informed consent form will describe the purpose of the study, the procedures to be followed, and the risk and benefits of participation. The investigator will conduct the informed consent discussion and will check that the subject comprehends the information provided and will answers any questions about the study. Consent will be voluntary and free from coercion. The investigator that will conduct the consent discussion will also sign the informed consent form. A copy of the informed consent form will be given to the subject and the fact that the subject has been consented to the study will be documented in the subject's record. When all the inclusion and exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject may be enrolled in the study. The following activities and/or assessments will be performed during screening, prior the treatment period start: demographic, medications related to the disease or symptoms and cancer history data collection; Urine-colture; randomization; Questionnaires QoL e IPSS. BCG or MMC will be started within 1-2 weeks from randomization (within 4-6 weeks after TURB). BCG or MMC will be administered once a week by intravesical instillation: BCG will be abministered for 6 weeks and MMC for 8 weeks. (induction cycles) Before instillations a physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes. IPSS questionnaire and QoL questionaire will be administered to the patient at week 1, 4 and 6/8 (6 for BCG and 8 for MMC) of treatment. 48 hours after post BCG or MMC intravesical instillation, patients of Arm A will undergo Hydeal Cyst intravesical instillation. BCG patiens will received 6 Hydeal Cyst intravesical instillation; MMC patiens will received 8 Hydeal Cyst intravesical instillation. After 2 weeks from BCG or MMC instillation end, IPSS e QoL questionaires will be administered and a control urino-colture will be executed. After 6 and 18 weeks from instillation therapy end, a control visit will be made. A physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes. Control cystoscopy and urino-colture will be executed (as for clinical practice) and IPSS and quality of life evaluated.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female ≥ 18 years of age

• ECOG PS 0-2

• Histologically confirmed diagnosis of non-muscle invasive bladder cancer, naïve and recurrent.

• Patients candidate to BCG or MMC intravesical induction therapy.

• Transurethral resection (TURB/re-TURB when indicated) performed in the last 4 weeks.

• IPSS score ≤10

• Negative urine culture within 2 weeks before T0

• For women who are not postmenopausal (i.e., \< 1 year after last menstruation) or surgical-ly sterile (absence of ovaries and/or uterus) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive de-vice, or barrier method of contraception in conjunction with spermicidal jelly) during the study period

• Signed the study informed consent prior to any study specific procedures.

• Will and ability to comply with the protocol

Locations
Other Locations
Italy
Humanitas Gavezzeni-Bergamo
RECRUITING
Bergamo
Ospedale Sant'Orsola - Malpighi
NOT_YET_RECRUITING
Bologna
Policlinico Ospedali Riuniti - Foggia
RECRUITING
Foggia
Azienda Ospedale Università Padova
RECRUITING
Padua
Istituto Oncologico Veneto IRCCS
RECRUITING
Padua
Ospedali Riuniti Padova Sud
RECRUITING
Padua
Policlinico Paolo Giaccone
RECRUITING
Palermo
Ospedale Santa Maria della Misericordia - ASU FC
RECRUITING
Udine
Azienda Ospedaliera Universitaria Integrata - Verona
RECRUITING
Verona
Contact Information
Primary
Antonio Amodeo, MD
antonio.amodeo@iov.veneto.it
0423 421321
Backup
Gian Luca De Salvo, MD
gianluca.desalvo@iov.veneto.it
049 8215710
Time Frame
Start Date: 2024-12-20
Estimated Completion Date: 2027-06
Participants
Target number of participants: 200
Treatments
Experimental: Arm A (interventional arm)
patients receive Hydeal Cyst intravesical instillations during the BCG or MMC therapy period.
No_intervention: Arm B (control arm)
patients receive only standard therapy (BCG or MMC).
Related Therapeutic Areas
Sponsors
Leads: Istituto Oncologico Veneto IRCCS
Collaborators: Fidia Farmaceutici s.p.a.

This content was sourced from clinicaltrials.gov