A Single-Arm, Open-Label, Prospective, Phase 0 Trial Evaluating the Safety and Efficacy of Salvage 177Lu-PSMA-I&T in Prostate Specific Antigen (PSA) Biochemical Failure After Radical Prostatectomy for High-Risk Prostate Cancer

Phase 1

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12623000073606
• Lead Sponsor: Dr Anthony-Joe Nassour

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-23
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

•Men who have undergone radical prostatectomy for National Comprehensive Cancer Network high or very high-risk prostate cancer.
•Negative surgical margins on radical prostatectomy histopathology.
•PSA initially undetectable following radical prostatectomy.
•PSA biochemical failure – defined as greater than or equal to 0.20ng/mL
•PSMA expressing prostate cancer on pre-operative 18F-DCFPyL PSMA PET/CT
•18F-DCFPyL PSMA PET/CT demonstrating no evidence of uptake to suggest detectable residual or metastatic disease
•No local recurrence on post-operative mpMRI
•No artifact disrupting interpretation of initial prostate cancer imaging
•Significant PSMA expressing tumour on initial staging
•Ability to give written informed consent, participate in and comply with study

Exclusion Criteria

•Previous diagnosis of prostate cancer
•Positive surgical margin on radical prostatectomy specimen pathology
•Non-PSMA expressing prostate cancer (e.g. ductal or neuroendocrine)
•Artifact disrupting interpretation of initial prostate cancer imaging (e.g. THR)
•Presence of suspected metastatic disease on pre-operative and post-operative 18F-DCFPyL PSMA PET/CT scan or mpMRI
•Undetectable serum testosterone
•Contraindication to Gadolinium
•Contraindication to 177Lu-PSMA therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified