AURORAX-0093A: Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study

Muscle-Invasive Bladder Carcinoma Clinical Trial

— AUR93A  

Official title:

Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05028660
• Other study ID #: ECD-AUR93A001
• Status: Recruiting
• Start date: July 21, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Elypta
• Contact: Francesco Gatto
• Phone: +46 (0)8 520 27 885
• Email: info[@]elypta.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

AURORAX-0093A (AUR93A) is a pilot cohort observational study that will explore the use of urine and plasma glycosaminoglycans (GAGs) to prognosticate muscle-invasive bladder cancer (MIBC) patients elected for neo-adjuvant chemotherapy (NAC).

Description:

There are around 200 000 cases of bladder cancer (BCa) in the EU every year. Of these, about 25% are diagnosed at a late stage wherein cancer has invaded the muscular wall. The survival of patients with muscle-invasive bladder cancer (MIBC) largely depends on the response to disease management, which in turn is likely dependent on the biology underlying different subtypes of MIBC.

The standard treatment is radical cystectomy (RC) and eligible patients are offered neo-adjuvant chemotherapy (NAC). However, only 30% of these patients report a complete response. Even though the response to NAC is likely correlated to the underlying tumor biology (for example, the TP53-like MIBC subtype is associated with a higher frequency of resistance to NAC), there are today no approved biomarkers to select patients likely to benefit from NAC. This information could in turn translate into more precise and personalized treatment for the patient.

In a proof-of-concept prospective study, we discovered that the profiling of urine and plasma glycosaminoglycans (GAGs) could be useful for the diagnosis and prognosis of BCa. AUR93A is a prospective single-arm cohort exploratory study. At least 76 patients with MIBC and elected for NAC will be included in this study and it is assumed that 30% will experience complete response at the post-operative visit. The goal is to correlate baseline (pre-NAC) GAGs to complete response rate (CRR) after RC and recurrence-free survival (RFS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of transitional cell carcinoma of the bladder (mixed histology tumors allowed if transitional cell histology is predominant [50%+] histology)

• Clinical stage T2-T4a N0-N2 M0 by CT (or MRI) + PET/CT

• Elected and fit according to institutional guidelines for cisplatin-based NAC followed by RC

• ECOG score 0-1

Exclusion Criteria:

• Previously intravenous chemotherapy for bladder cancer. (Patients who have had previous radiotherapy or concurrent chemo-radiation for bladder cancer are still eligible.)

• Currently participating or has participated in a study of an investigational agent and received study therapy or received investigational device within 4 weeks before the first dose NAC

• Known additional malignancy that is progressing or requires active treatment except for basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.

(A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable provided that the following criteria are met: Stage T2N0M0 or lower, Gleason score less/equal to 7 and prostatic-specific antigen (PSA) undetectable for at least 1 year while off androgen deprivation therapy that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year before study allocation. Pathological evidence of concurrent T1a/b prostate cancer after radical cystecto-prostatectomy are still eligible.)

• Evidence of measurable nodal or metastatic disease.

Related Conditions & MeSH terms

• Muscle-Invasive Bladder Carcinoma
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• GAG score
blood and urine samples to determine GAG scores

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Roskilde
Italy	AOU Careggi	Florence
Italy	AOU Careggi	Florence
Italy	IRCCS Ospedale San Raffaele, San Raffaele Hospital	Milano
Italy	IRCCS Regina Elena	Rome
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Elypta	Lund University

Countries where clinical trial is conducted

Denmark,  Italy,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with complete response at the post-operative visit after RC.	Percentage point difference in complete response rates between GAG favorable and GAG poor patients	15 to 90 days after radical cystectomy surgery
Secondary	Proportion of patients with recurrence at any time after treatment	Percentage point difference in recurrence rates between GAG favorable and GAG poor patients	15 to 90 days after radical cystectomy surgery
Secondary	Proportion of complete responses after NAC according to CT-based RECIST v1.1	Percentage point difference in complete response rates after NAC between GAG favorable and GAG poor patients	15 to 90 days after radical cystectomy surgery