Plain-English translation of NCT05969964 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This trial compares two approaches for patients with early-stage bladder cancer (called pT1) who have already had a thorough initial surgery called en-bloc resection. Half of the patients will receive a second surgery as standard practice recommends, while the other half will skip the second surgery and go straight to immunotherapy treatment. The trial wants to find out if skipping the second surgery is safe and doesn't harm outcomes.
Current guidelines recommend a second surgery for all early bladder cancer patients, but this second procedure carries risks like bladder damage and delays to the next treatment, which can actually increase the chance of cancer coming back. This trial exists to see whether patients who had a very thorough first surgery with clear margins can safely avoid the second surgery and start their next treatment sooner.
You likely qualify if…
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You will be randomly assigned to one of two groups. One group will have a second look surgery within 2 to 6 weeks to check for any remaining cancer and confirm the muscle layer wasn't invaded. The other group will skip this second surgery and start intravesical BCG immunotherapy treatment immediately. Both groups will be followed regularly with imaging and cystoscopy (a camera look inside the bladder) to watch for any cancer recurrence or progression.
AI-generated summary from trial data · Jun 7, 2026 · Not medical advice
Egypt
Sponsor
Mansoura University
Enrollment target
~370 participants
Started
July 2023
Primary completion
August 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
18 Years – 80 Years
Last updated on clinicaltrials.gov in October 2024.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Mahmoud Laymon, MD,MRCS
Urology &Nephrology Center, Mansoura University, Egypt
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.