Trial Title:
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
NCT ID:
NCT06245603
Condition:
Non-muscle Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Multicentre open-label, controlled, randomized clinical trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Hydeal Cyst®
Description:
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.
Arm group label:
Arm A (interventional arm)
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 12 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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) 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
Exclusion Criteria:
- Upper urinary tract urothelial carcinoma (UTUC); bladder diverticula; urethral
stenosis; difficult catheterization; reduced bladder compliance; increased bladder
compliance; post-voiding residue > 150 ml;
- Surgery or invasive procedures planned during the study and interfering with
evaluation about efficacy and safety of it.
- Female patients with child-bearing potential must not be pregnant or lactating, or
not willing to use adequate contraception for the duration of study
- Pelvic radiotherapy within 24 weeks prior to the beginning of the study treatment.
- Urinary tract infection requiring antibiotics
- Have a known hypersensitivity to any substance present in the investigational
device.
- Neurogenic bladder
- Any condition for that, in the opinion of the Investigator, participation would not
be in the best interest of the subject.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Humanitas Gavezzeni-Bergamo
Address:
City:
Bergamo
Zip:
24125
Country:
Italy
Contact:
Last name:
Angelo Porreca, MD
Phone:
0354204500
Phone ext:
+39
Email:
info@angeloporreca.it
Facility:
Name:
Ospedale Sant'Orsola - Malpighi
Address:
City:
Bologna
Country:
Italy
Contact:
Last name:
Francesco Chessa, MD
Phone:
0512142545
Phone ext:
+39
Email:
francesco.chessa@aosp.bo.it
Investigator:
Last name:
Francesco Chessa, MD
Email:
Principal Investigator
Facility:
Name:
Policlinico Ospedali Riuniti - Foggia
Address:
City:
Foggia
Country:
Italy
Contact:
Last name:
Gian Maria Busetto, MD
Email:
gianmaria.busetto@unifg.it
Investigator:
Last name:
Gian Maria Busetto, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Oncologico Veneto IRCCS
Address:
City:
Padova
Zip:
35128
Country:
Italy
Contact:
Last name:
Antonio Amodeo, MD
Phone:
0423 421321
Phone ext:
+39
Email:
antonio.amodeo@iov.veneto.it
Contact backup:
Last name:
Gian Luca De Salvo, MD
Phone:
049 8215710
Phone ext:
+39
Email:
gianluca.desalvo@iov.veneto.it
Investigator:
Last name:
Antonio Amodeo, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedale Università Padova
Address:
City:
Padova
Country:
Italy
Contact:
Last name:
Fabrizio Dal Moro, MD
Phone:
0498218599
Phone ext:
+39
Email:
fabrizio.dalmoro@unipd.it
Investigator:
Last name:
Fabrizio Dal Moro, MD
Email:
Principal Investigator
Facility:
Name:
Ospedali Riuniti Padova Sud
Address:
City:
Padova
Country:
Italy
Contact:
Last name:
Nicola Zanovello, MD
Phone:
0429715516
Phone ext:
+39
Email:
nicola.zanovello@aulss6.veneto.it
Investigator:
Last name:
Nicola Zanovello, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Santa Maria della Misericordia - ASU FC
Address:
City:
Udine
Country:
Italy
Contact:
Last name:
Alessandro Crestani, MD
Phone:
0432552931
Phone ext:
+39
Email:
alessandro.crestani@asufc.sanita.fvg.it
Investigator:
Last name:
Alessandro Crestani, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata - Verona
Address:
City:
Verona
Country:
Italy
Contact:
Last name:
Alessandro Antonelli, MD
Phone:
0458127702/03
Phone ext:
+39
Email:
alessandro.antonelli@aovr.veneto.it
Investigator:
Last name:
Alessandro Antonelli, MD
Email:
Principal Investigator
Start date:
December 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Istituto Oncologico Veneto IRCCS
Agency class:
Other
Collaborator:
Agency:
Fidia Farmaceutici s.p.a.
Agency class:
Industry
Source:
Istituto Oncologico Veneto IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06245603
