Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-06

Study Completion Date

2024-11-14

Brief Summary

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Bladder cancer is the fifth most common cancer in Canada and there has been relatively little progress in altering its clinical course over the last three decades. One of the major problems identified in the management of this disease, is under staging of muscle invasive disease which can lead to suboptimal treatment and outcomes. PET-CT has the potential to more accurately stage MIBC than standard CT by detecting pelvic adenopathy and/or distant sites of disease that may not be found on standard imaging. In the former situation, more aggressive therapy with extended lymph node dissection and/or neoadjuvant chemotherapy prior to cystectomy can be offered. While in the latter situation patients can be spared the morbidity of a cystectomy performed in a setting of metastatic disease. This study will address whether PET-CT adds a clinically meaningful difference in care.

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Detailed Description

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A multicenter randomized controlled trial will be performed. Patients usually present with symptoms (e.g., painless hematuria). The urologist will perform cystoscopy and if urothelial cancer of the bladder is suspected, the patient is taken to the operating room for an examination under anesthesia (EUA) and a TURBT. If this shows muscle invasion then conventional staging with CT chest, abdomen, and pelvis is performed. The patient who has TNM Stage T2a-T4a N0-3 M0 is eligible to be enrolled in the trial. Eligible consenting patients will be randomized 2:1 to PET-CT or none (Control). The actual treatment received by the patient will be documented. The primary outcome measure is treatment received.

Conditions

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Muscle-invasive Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Whole-body FDG PET-CT

Whole-body FDG PET-CT (Experimental arm)

Group Type EXPERIMENTAL

Whole-body FDG PET-CT

Intervention Type OTHER

No PET-CT

No PET-CT (Control arm)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Whole-body FDG PET-CT

Intervention Type OTHER

Other Intervention Names

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PET-CT imaging

Eligibility Criteria

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Inclusion Criteria

* Men and women with newly diagnosed muscle-invasive high grade urothelial carcinoma of the bladder (TNM stage T2a-T4a, N0-3, M0), who are eligible for either radical cystectomy or radiotherapy-based bladder conservation.
* Being considered for treatment of curative intent.

Exclusion Criteria

* Age \< 18 years.
* ECOG performance status \>2.
* Predominant histology (\>50% of specimen) involves non-urothelial cell carcinoma.
* Prior partial cystectomy.
* Prior pelvis surgery that obviates a completed extended lymphadenectomy (e.g., aorto-femoral/iliac bypass) or for whom the surgeon feels that their ability to perform a standard or extended pelvic node dissection would be compromised.
* Contraindications to FDG PET-CT.
* Inability to lie supine for imaging with PET-CT.
* Inadequate hepatic function:

(i) Bilirubin \>1.5 X ULN and (ii) SGOT and Alkaline phosphatase \>3 X ULN
* History of another invasive malignancy within the previous 5 years with the exception of non-melanoma skin cancer.
* Known pregnancy or lactating female.
* Inability to complete the study or required follow-up.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No