Actively Recruiting
Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
Led by Theralase® Technologies Inc. · Updated on 2025-11-24
90
Participants Needed
16
Research Sites
430 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary disease (Ta, T1)) that are considered Bacillus Calmette-Guerin ("BCG")-Unresponsive or who are intolerant to BCG therapy. BCG-Unresponsive is at least one of the following: At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy; or, at least five of six doses of an initial induction course plus at least two of six doses of a second induction course. Patients experiencing disease relapse within 12 months after finishing the second course of BCG therapy are considered BCG-Unresponsive. The Study will consist of 90 patients who will undergo one (1) Study Procedure, with up to two (2) additional re-induction Study Procedures based on patient response.
CONDITIONS
Official Title
Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- Age over 18 years at consent.
- Histologically confirmed NMIBC CIS with or without resected papillary disease (Ta, T1) within 12 weeks before treatment.
- Intolerant to BCG or BCG-Unresponsive based on specific dosage criteria.
- Not a candidate for or refusing radical cystectomy.
- ECOG performance score between 0 and 2.
- Adequate bladder function to retain study drug for at least 60 minutes.
- Available for the entire study duration including approximately 15 months follow-up.
- Female patients of childbearing potential must have a negative pregnancy test at screening.
- Female patients of childbearing potential must agree to use two methods of birth control or abstain from heterosexual activity for two weeks after treatment.
You will not qualify if you...
- Past or current muscle invasive or metastatic urothelial carcinoma.
- Concurrent extravesical non-muscle invasive transitional cell carcinoma within 3 months before enrollment.
- Active gross hematuria.
- Known additional progressing malignancy requiring active treatment, except certain skin, cervical, or prostate cancers under specified conditions.
- Conditions or abnormalities that might interfere with study participation or results.
- Receiving prohibited concomitant therapies.
- Participation in another investigational study within 1 month before current treatment.
- Prior intravesical chemotherapy within 1 month before treatment, except a single perioperative dose.
- Active infection requiring systemic therapy including unresolved urinary tract infection.
- Contraindication to general or spinal anesthesia.
- Pregnant or breastfeeding during the study period until two weeks after last treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Site 02-012 - University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Site 02-016 - Urology of Indiana
Greenwood, Indiana, United States, 46143
Actively Recruiting
3
Site 02-015 - Associated Medical Professionals of New York
Syracuse, New York, United States, 13210
Actively Recruiting
4
Site 02-017 - Central Ohio Urology Group
Gahanna, Ohio, United States, 43230
Actively Recruiting
5
Site 02-008 - MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Terminated
6
Site 02-006 - Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
7
Site 02-007 - Urology Associates, P. C
Nashville, Tennessee, United States, 37209
Actively Recruiting
8
Site 02-010 - Urology San Antonio P. A
San Antonio, Texas, United States, 78229
Terminated
9
Site 02-009 - Virginia Urology
Richmond, Virginia, United States, 23235
Terminated
10
Site 02-011 - University of Wisconsin Health University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
11
Site 01-005 - The Vancouver Prostate Centre - Diamond Health Care Centre - Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
12
Site 01-004 - Nova Scotia Health Authority - Centre for Applied Urology Research
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
13
Site 01-014 - St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
14
Site 01-002- London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada, N6A 5W9
Actively Recruiting
15
Site 01-001 - University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
16
Site 01-003 - McGill University Health Centre - Glen-Cedars Cancer Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
A
Arkady Mandel, MD, PhD, DSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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