The Effect of Glioblastoma PSMA Expression Following Tumour VEGF Blockade From Bevacizumab

NCT07052877 | Not Yet Recruiting

• 1 other identifier: GUAVA
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a single arm study for patients receiving bevacizumab for IDH-wildtype glioblastoma. Patients receiving bevacizumab (an anti-VEGF therapy) will receive PSMA scans to investigate the role of PSMA expression in glioblastoma and its relationship to VEGF expression.

Conditions

Glioblastoma; Glioblastoma Multiforme (GBM)

Keywords

glioblastoma; anti-VEGF; PSMA; bevacizumab; VEGF; glioma; astrocytoma

Outcome Measures

Primary Outcomes (1)

• Changes in PSMA PET metabolic tumour volume (MTV) before and after bevacizumab administration.

  Prior to first administration of bevacizumab to 6 weeks after.

Other Outcomes (3)

• Changes in PSMA PET SUVmax before and after bevacizumab administration.

  Prior to first administration of bevacizumab to 6 weeks after.

• Changes in PSMA PET SUVmean before and after bevacizumab administration.

  Prior to first administration of bevacizumab to 6 weeks after.

• Changes in PSMA PET SUVpeak before and after bevacizumab administration.

  Prior to first administration of bevacizumab to 6 weeks after.

Study Arms (1)

Patients with glioblastoma receiving Bevacizumab as part of their standard of care

Diagnostic Test: PSMA PET/CT scan

Interventions

PSMA PET/CT scan DIAGNOSTIC_TEST

PSMA PET scan will be used to monitor changes in PSMA expression in response to bevacizumab.

Patients with glioblastoma receiving Bevacizumab as part of their standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glioblastoma patients receiving Bevacizumab as part of standard of care.

You may qualify if:

• \> 18 year of age
• ECOG 0-2
• Able to provide informed consent for the study
• Minimum of 1 month from completion of radiotherapy with clinical or radiography evidence suggesting residual tumour
• Confirmed glioblastoma IDH1/2 wildtype (WHO2021)
• For bevacizumab treatment as per treating physician
• Able to comply with trial requirements

You may not qualify if:

• No major organ impairment that would likely lead to unacceptable toxicities- eg significant cardiac, hepatic, renal or haematologic dysfunction (based on clinician assessment)
• Any contraindication to bevacizumab, MRI gadolinium contrast or 68Ga-PSMA-617 radioisotope
• Any implant, foreign body, 3T MRI incompatible device or other contraindication to MRI imaging
• Does not fulfill PBS requirements for bevacizumab
• Women lactating, pregnant or of child baring potential who are not willing to avoid pregnancy during the study

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples including plasma.

MeSH Terms

Conditions

Glioblastoma; Glioma; Astrocytoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Alexander Yuile

CONTACT

+61 2 94631171; Alexander.Yuile@health.nsw.gov.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 7, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)