Intravesical PDT for Bladder Cancer Unresponsive to BCG

Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients

Recruiting Phase 2 Interventional Study
Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Theralase® Technologies Inc. · Industry
Who this trial is looking for

This trial is looking for patients with specific types of bladder cancer that haven’t responded to a treatment called BCG. Participants will receive a special light therapy to help treat their condition.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am over 18 years old.
  • I have been diagnosed with non-muscle invasive bladder cancer.
  • I have not responded to BCG therapy.
  • I am willing to provide written consent to participate.
  • I can keep a study drug in my bladder for at least 60 minutes.
  • I am available for follow-up for about 15 months.
  • I am not a candidate for surgery to remove my bladder.
  • If I am a woman able to have children, I have a negative pregnancy test.

You may not be able to join if

  • I have had muscle invasive bladder cancer.
  • I have a current bladder cancer in other areas outside the bladder.
  • I have active blood in my urine.
  • I have another type of cancer that needs treatment.
  • I have an active infection that needs treatment.
  • I am currently pregnant or breastfeeding.
  • I have had recent treatment with other chemotherapy drugs.
  • I cannot tolerate general anesthesia.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About This Trial
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: …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Be willing and able to provide a written Informed Consent Form ("ICF") for the Study. 2. Be \> 18 years of age on day of signing ICF. 3. Have histologically confirmed NMIBC CIS via biopsy with/without resected papillary disease (Ta, T1) (high grade) using the 2004 World Healt…
Contacts

Arkady Mandel, MD, PhD, DSc

416-699-5273

amandel@theralase.com

CONTACT