Prognostic Accuracy and Clinical Effectiveness of 68Ga-PSMA-11 PET/CT (ILLUCIX®) Imaging Followed by 177-Lu-PSMA-617 Therapy in Metastatic Castration-Resistant Prostate Cancer: A Systematic Literature Review
Author(s)
Geetank Kamboj, MPharm1, Aastha Radotra, MPH1, Parinita Barman, MPH1, Surabhi Aggarwal, MPharm1, George Papadopoulos, BSc (Hons)2, Michael Aristides, MSc2, Blaise Agresta, MBA2, Hemant Rathi, MSc1.
1Skyward Analytics, Gurugram, India, 2Lucid Health Consulting, Sydney, Australia.
1Skyward Analytics, Gurugram, India, 2Lucid Health Consulting, Sydney, Australia.
OBJECTIVES: To evaluate the prognostic accuracy of 68Ga-PSMA-11 PET/CT imaging for treatment response assessment and its clinical effectiveness compared to no PSMA PET/CT imaging in patients with metastatic castration-resistant prostate cancer (mCRPC) who are potential candidates for PSMA-targeted radioligand therapy.
METHODS: A literature search was conducted across Embase, Medline, and the Cochrane Library from inception to May 2025 to July 2023 to identify single-arm studies, observational studies, and randomized controlled trials (RCTs). Studies were included if they evaluated the prognostic accuracy of ⁶⁸Ga-PSMA-11 PET/CT imaging for treatment response assessment, or if they compared the clinical effectiveness of 68Ga-PSMA-11 PET/CT imaging followed by 177Lu-PSMA-617 therapy (as a proxy for PSMA radioligand therapy) versus no PSMA PET/CT imaging followed by cabazitaxel or best supportive care (BSC) in patients with progressive or symptomatic mCRPC.
RESULTS: Sixteen publications reporting on 15 studies (three RCTs and 12 observational studies) were included. The evidence supports the use of ⁶⁸Ga-PSMA-11 PET/CT imaging for selecting patients for PSMA-targeted radioligand therapy and for early, accurate treatment response assessment. Although no studies directly evaluated the impact of 68Ga-PSMA-11 PET/CT imaging on patient health outcomes, evidence from two pivotal RCTs (TheraP and VISION) demonstrated that ¹⁷⁷Lu-PSMA-617 significantly improved progression-free survival and objective response rates compared to cabazitaxel and BSC. The VISION trial reported a significant overall survival benefit for 177Lu-PSMA-617 versus BSC (HR=0.62 [95% CI: 0.52-0.74]; p<0.001), while the TheraP trial found similar OS between 177Lu-PSMA-617 and cabazitaxel (median OS: 19.1 versus 19.6 months).
CONCLUSIONS: This review supports the theranostic approach of using ⁶⁸Ga-PSMA-11 PET/CT imaging to identify suitable candidates for PSMA-targeted radioligand therapy and to enable accurate assessment of treatment response. While direct evidence of imaging-related health outcomes is lacking, downstream improvements in clinical outcomes with ¹⁷⁷Lu-PSMA-617 validate the utility of this imaging-guided treatment strategy in mCRPC.
METHODS: A literature search was conducted across Embase, Medline, and the Cochrane Library from inception to May 2025 to July 2023 to identify single-arm studies, observational studies, and randomized controlled trials (RCTs). Studies were included if they evaluated the prognostic accuracy of ⁶⁸Ga-PSMA-11 PET/CT imaging for treatment response assessment, or if they compared the clinical effectiveness of 68Ga-PSMA-11 PET/CT imaging followed by 177Lu-PSMA-617 therapy (as a proxy for PSMA radioligand therapy) versus no PSMA PET/CT imaging followed by cabazitaxel or best supportive care (BSC) in patients with progressive or symptomatic mCRPC.
RESULTS: Sixteen publications reporting on 15 studies (three RCTs and 12 observational studies) were included. The evidence supports the use of ⁶⁸Ga-PSMA-11 PET/CT imaging for selecting patients for PSMA-targeted radioligand therapy and for early, accurate treatment response assessment. Although no studies directly evaluated the impact of 68Ga-PSMA-11 PET/CT imaging on patient health outcomes, evidence from two pivotal RCTs (TheraP and VISION) demonstrated that ¹⁷⁷Lu-PSMA-617 significantly improved progression-free survival and objective response rates compared to cabazitaxel and BSC. The VISION trial reported a significant overall survival benefit for 177Lu-PSMA-617 versus BSC (HR=0.62 [95% CI: 0.52-0.74]; p<0.001), while the TheraP trial found similar OS between 177Lu-PSMA-617 and cabazitaxel (median OS: 19.1 versus 19.6 months).
CONCLUSIONS: This review supports the theranostic approach of using ⁶⁸Ga-PSMA-11 PET/CT imaging to identify suitable candidates for PSMA-targeted radioligand therapy and to enable accurate assessment of treatment response. While direct evidence of imaging-related health outcomes is lacking, downstream improvements in clinical outcomes with ¹⁷⁷Lu-PSMA-617 validate the utility of this imaging-guided treatment strategy in mCRPC.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO190
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
Genetic, Regenerative & Curative Therapies, Oncology, Personalized & Precision Medicine