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.
Resources from the same session
1831P - Dissecting the meaning of obesity in metastatic castration resistant prostate cancer: Size or metabolism?
Presenter: Lisa Horvath
Session: Poster session 15
1832P - Centralized screening for homologous recombination repair (HRR) genes in metastatic castration-resistant prostate cancer (mCRPC): A feasibility study from a multicenter Spanish cohort
Presenter: Javier Freire
Session: Poster session 15
1833P - Concurrent high-dose IV Vitamin C (IVC) and docetaxel for metastatic castrate-resistant prostate cancer (mCRPC): A randomized, placebo-controlled, double-blind phase II trial
Presenter: Channing Paller
Session: Poster session 15
1834P - Exposure-efficacy analyses of talazoparib in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) in the TALAPRO-2 trial
Presenter: Arun Azad
Session: Poster session 15
1835P - A prospective study to determine the prevalence of DNA repair defects in patients (pts) with advanced prostate cancer (PC)
Presenter: Shahneen Sandhu
Session: Poster session 15
1836P - Blood based biomarkers identify metastatic castration-resistant prostate cancer (mCRPC) with the greatest benefit from continuing enzalutamide (ENZ) beyond progression in combination with docetaxel (Doc): A pre-specified biomarker study of the phase IIIb PRESIDE trial
Presenter: Maria Ruiz Vico
Session: Poster session 15
1837P - Assessing PSA
Presenter: Susan Halabi
Session: Poster session 15
1839P - Circulating tumor DNA (ctDNA) low pass whole genome sequencing (lpWGS) studies identify genomic alterations associating with taxane outcomes in prospective phase III taxane trials for metastatic castration resistant prostate cancer (mCRPC) sufferers
Presenter: George Seed
Session: Poster session 15
1840P - RNASEH2B loss and PARP inhibition (parpi) in metastatic castration resistant prostate cancer (mCRPC)
Presenter: Juliet Carmichael
Session: Poster session 15