Abstract 1823P
Background
Imaging prior to Radium-223 therapy (Ra-223) is crucial for selecting metastatic castration-resistant prostate cancer (mCRPC) patients with bone-only disease. The purpose of this study was to evaluate if baseline PSMA PET/CT versus CT is associated with biochemical response during Ra-223.
Methods
A secondary analysis of the data of a prospective observational study (NCT04995614) was performed. Patients received a maximum of six cycles of Ra-223 and were retrospectively divided into the PSMA PET/CT (bPSMA) or CT (bCT) group based on baseline imaging technique. All patients received baseline bone scintigraphy. Primary endpoints were alkaline phosphatase (ALP) and prostate specific antigen (PSA) response, defined as ≥ 30% decline from baseline. Secondary endpoints were overall survival (OS) and radiological response.
Results
Between 2017 and 2020, 122 mCRPC patients were included: 18 (14.8%) in the bPSMA and 104 (85.2%) in the bCT group. All baseline characteristics were comparable. No significant differences in ALP or PSA response were found between the groups. The bCT group showed a significant shorter OS compared to the bPSMA group (12.4 vs.19.9 months, p < 0.01, table). Post-therapy soft tissue involvement (STI) was detected in 29/76 patients (38.2%) that received bCT and post-therapy CT (bCT/pCT), compared to 0/18 bPSMA patients. No significant difference in OS was found between bCT/pCT patients without STI and bPSMA patients. Table: 1823P
OS (months) among subgroups
Baseline imaging | Post-therapy imaging | N | Median OS (IQR) | P-value |
PSMA | Total PSMA A. STI B. W/o STI CT C. STI D. W/o STI No imaging | 18 11/18 0/11 11/11 4/18 0/4 4/4 3/18 | 19.9 (12.7 – 29.0) - - 21.2 (14.7 – 40.8) - - 20.3 (15.2 – 36.8) 4.9 (3.1 - NR) | 0.038 vs. bCT - - - - - - - |
CT | Total PSMA A. STI B. W/o STI CT C. STI D. W/o STI E. Unknown STI No imaging | 104 7/104 6/7 1/7 76/104 29/76 44/76 3/76 21/104 | 12.4 (7.9 – 18.2) - 14.6 (11.5 – 24.9) 21.5 (NR) - 10.6 (6.0 – 14.2) 14.8 (9.3 – 26.0) - 9.2 (4.0 – 12.9) | 0.038 vs. bPSMA - - - - <0.01 vs. bCT/pCT w/o STI 0.457 vs. bPSMA - - |
Abbreviations: W/o, without; NR, not reached.
Conclusions
bPSMA versus bCT does not seem to predict biochemical response during Ra-223. Nevertheless, patients in the bCT group had a significantly shorter OS, most likely due to underdetection of STI in this group. Therefore, replacing baseline CT with PSMA PET/CT appears to be a valuable screening method to ensure in-label use of Ra-223.
Clinical trial identification
NCT04995614.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Bayer.
Disclosure
D. Bosch: Financial Interests, Personal, Invited Speaker: MSD AstraZeneca. W.J.G. Oyen: Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor: Bayer, AAA Novartis. D.M. Somford: Financial Interests, Personal, Advisory Board: Janssen Pharmaceuticals, Bayer, Astellas; Financial Interests, Institutional, Research Grant: Astellas. R. Hermsen: Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Other, Personal fees and travel expenses: Bayer. N. Mehra: Financial Interests, Personal and Institutional, Advisory Board, And personal fees and research funding: Bayer; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal and Institutional, Advisory Board, And research grants and personal fees: Roche, Merck Sharp and Dohme; Financial Interests, Personal and Institutional, Advisory Board, And research grants, research funding and personal fees: Astellas, Janssen Pharmaceuticals; Financial Interests, Personal and Institutional, Other, Research grants and personal fees: AstraZeneca, Sanofi; Financial Interests, Institutional, Research Grant: Pfizer, Genzyme. W.R. Gerritsen: Financial Interests, Personal, Advisory Board: BMS, Sanofi Gemzyme, Amgen, Morphosys and CureVac; Financial Interests, Personal and Institutional, Advisory Board, Plus research funding: Astellas, Janssen Pharmaceuticals; Financial Interests, Personal and Institutional, Advisory Board, Plus research funding and speaker fees: Bayer; Financial Interests, Personal, Invited Speaker: MSD. M.J. van der Doelen: Financial Interests, Institutional, Research Grant: Bayer, Janssen Pharmaceuticals; Financial Interests, Personal, Other, Speaker fees: Astellas. I.M. van Oort: Financial Interests, Personal and Institutional, Advisory Board, Plus research funding: MSD/AstraZeneca; Financial Interests, Personal and Institutional, Research Grant, Plus research funding and personal fees: Astellas, Bayer; Financial Interests, Personal and Institutional, Research Grant, Plus personal fees: Janssen Pharmaceuticals; Financial Interests, Personal and Institutional, Research Funding: Pfizer; Financial Interests, Institutional, Research Funding: AAA Novartis. All other authors have declared no conflicts of interest.
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