Phase 4 Bladder Cancer Trial, Recruiting NCT05962541 Sponsor: University of Roma La Sapienza Condition: Bladder Cancer
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Phase 4 Bladder Cancer Trial, Recruiting

NCT05962541
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older (male or female) who have been referred because bladder cancer is suspected — either for the first time or as a return of a previous cancer — and whose doctor has recommended a surgical procedure to remove bladder tissue (called a TURBT).
  • People who have already had a TURBT that confirmed a type of bladder cancer that has not grown into the muscle wall, and whose doctor has recommended a second surgical look and removal procedure (called a Re-TURBT), in line with standard European urology guidelines.
  • People whose scans (such as an MRI) show no signs that the cancer has grown into the bladder muscle, spread to nearby tissue, or spread to other parts of the body — only certain early-stage cancer types will be considered.
  • People who have previously received a bladder treatment called BCG immunotherapy, as well as people who have never had it before.
  • People who are well enough to go through all of the procedures required by the trial.
  • People who are able to give written consent to take part.

Who may not be able to join:

  • People for whom TURBT or Re-TURBT surgery is medically unsuitable.
  • People whose first TURBT showed that the cancer has grown into the bladder muscle (stage T2) or has spread to surrounding tissue (stages T3–T4).
  • People whose scans show the cancer has already spread to lymph nodes or other parts of the body before surgery.
  • People whose bladder cancer appeared before the first TURBT to be low-risk and small (a single tumour smaller than 1 cm).
  • People whose initial camera examination of the bladder showed signs that the cancer may have grown into the muscle wall (based on how the tumour looked).
  • People whose TURBT results show a type of early-stage bladder cancer that does not meet the European urology guidelines for needing a Re-TURBT.
  • People who have a tumour in the upper urinary tract (in the kidney or the tube connecting the kidney to the bladder), found on imaging.
  • People for whom the bladder treatment BCG immunotherapy is medically unsuitable.
  • People who are not well enough to go through all of the procedures required by the trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: +39 3395382464

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
University of Roma La Sapienza
Registry
ClinicalTrials.gov
Start date
22 December 2025
Est. completion
1 December 2028

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Proportion of EARLY Bladder Cancer (BCa) recurrences

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov