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Multicenter Study
. 2022 Nov;63(11):1651-1658.
doi: 10.2967/jnumed.121.263072. Epub 2022 Apr 14.

Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study

Andrei Gafita  1   2 , Isabel Rauscher  2 , Manuel Weber  3 , Boris Hadaschik  4 , Hui Wang  2 , Wesley R Armstrong  5 , Robert Tauber  6 , Tristan R Grogan  7 , Johannes Czernin  5 , Matthew B Rettig  8 , Ken Herrmann  3 , Jeremie Calais  5 , Wolfgang A Weber  2 , Matthias R Benz  5 , Wolfgang P Fendler  3 , Matthias Eiber  2
Affiliations
Multicenter Study

Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study

Andrei Gafita et al. J Nucl Med. 2022 Nov.

Erratum in

  • Erratum.
    [No authors listed] [No authors listed] J Nucl Med. 2023 Sep;64(9):1503. J Nucl Med. 2023. PMID: 37657930 Free PMC article. No abstract available.

Abstract

Our objective was to develop version 1.0 of a novel framework for response evaluation criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) and a composite response classification that combines responses by prostate-specific antigen (PSA) measurements and by RECIP 1.0 (PSA + RECIP). Methods: This was an international multicenter, retrospective study. One hundred twenty-four men with metastatic castration-specific prostate cancer (mCRPC) who underwent 177Lu-PSMA therapy and received PSMA PET/CT at baseline and at an interim time point of 12 wk were included. Pairs of baseline interim PET/CT scans were interpreted by consensus among 3 masked readers for appearance of new lesions. Tumor lesions were segmented, and total PSMA-positive tumor volume (PSMA-VOL) was obtained. Appearance of new lesions and changes in PSMA-VOL were combined to develop RECIP 1.0, which included classifications of complete response (RECIP-CR: absence of any PSMA-ligand uptake on interim PET/CT), partial response (RECIP-PR: decline ≥ 30% in PSMA-VOL and no appearance of new lesions), progressive disease (RECIP-PD: increase ≥ 20% in PSMA-VOL and appearance of new lesions), and stable disease (RECIP-SD: any condition but RECIP-PR or RECIP-PD). Changes in PSA levels at 12 wk by Prostate Cancer Working Group Criteria 3 were recorded. PSA + RECIP results were defined as response (PSA decline ≥ 50% or RECIP-PR/CR) or progression (PSA increase ≥ 25% or RECIP-PD). The study's primary outcome measure was the prognostic value of RECIP 1.0 for overall survival (OS). The secondary outcome measure was the prognostic accuracy (C-index) of PSA + RECIP versus PSA responses. Results: Patients with RECIP-PD (n = 39; 8.3 mo) had a shorter OS than patients with stable disease (RECIP-SD) (n = 47; 13.1 mo; P < 0.001) or RECIP-PR (n = 38; 21.7 mo; P < 0.001). In identifying responders and progressors, PSA + RECIP had C-indices superior to those of PSA only: 0.65 versus 0.62 (P = 0.028) and 0.66 versus 0.63 (P = 0.044), respectively. Conclusion: PSMA PET/CT by RECIP 1.0 is prognostic for OS and can be used as a response biomarker to monitor early efficacy of 177Lu-PSMA in men with mCRPC. PSA + RECIP may be used as a novel composite endpoint in mCRPC clinical trial design.

Keywords: 177Lu-PSMA; PSMA PET; interim PET; metastatic castration-resistant prostate cancer; radionuclide treatment.

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Figures

None
Graphical abstract
FIGURE 1.
FIGURE 1.
Study design. Patients who received bPET, were treated with at least 2 cycles of LuPSMA, subsequently received iPET, and had available survival data were included in this analysis. Tumor segmentation on both scans was performed using qPSMA software, and changes in total PSMA-VOL were calculated. Three independent readers interpreted scans for appearance of new lesion, and disagreement was solved by consensus reading. Changes in PSMA-VOL and consensus read results for appearance of new lesions were combined to develop RECIP. Serum PSA levels at bPET and at iPET were collected, and changes were recorded. PSA and RECIP responses were combined to develop composite response classification (PSA + RECIP). Prognostic ability for OS of PSA + RECIP vs. PSA only was tested.
FIGURE 2.
FIGURE 2.
Changes in tumor burden on semiautomatic quantitative assessment of 68Ga-PSMA-11 PET/CT imaging using qPSMA software. Tumor lesions on bPET and iPET 68Ga-PSMA-11 PET/CT scans were segmented. Manual adjustments were performed when necessarily. Whole-body PSMA-VOL was extracted. DICOM images (A and C) are uploaded by user, and semiautomatic tumor segmentation (B and D) of bone (red), lymph node (green), and visceral (orange) metastases is obtained.
FIGURE 3.
FIGURE 3.
(A and B) Kaplan–Meier plots showing associations between appearance of new lesions (A) and response according to PSMA-VOL by qPSMA (B) with OS. Curves were truncated after 50 mo of follow-up because of low number of patients at risk. (C) Waterfall plot depicting relation between changes in PSMA-VOL and appearance of new lesions (NL) on PSMA PET. Asterisks indicate increase > 100% in PSMA-VOL changes.
FIGURE 4.
FIGURE 4.
(A) Kaplan–Meier plot showing associations of imaging response according to RECIP with OS. Curves were truncated after 50 mo of follow-up because of low number of patients at risk. (B) Waterfall plot depicting relation between changes in PSA levels and imaging response according to RECIP. Asterisks indicate increase > 100% in PSA changes.
FIGURE 5.
FIGURE 5.
Kaplan–Meier plots showing associations with OS of response vs. nonresponse in PSMA PET/CT according to RECIP (RECIP-PR vs. no RECIP-PR) in patients without PSA response (A) and of progression vs. nonprogression in PSMA PET/CT according to RECIP (RECIP-PD vs. no RECIP-PD) in patients without PSA progression (B).
See this image and copyright information in PMC

References

    1. Hofman MS, Lawrentschuk N, Francis RJ, et al. . Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 2020;395:1208–1216. - PubMed
    1. FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. U.S. Food and Drug Administration website. https://www.fda.gov/news-events/press-announcements/fda-approves-first-p.... Published December 1, 2020. Accessed July 21, 2021.
    1. Seitz AK, Rauscher I, Haller B, et al. . Preliminary results on response assessment using 68Ga-HBED-CC-PSMA PET/CT in patients with metastatic prostate cancer undergoing docetaxel chemotherapy. Eur J Nucl Med Mol Imaging. 2018;45:602–612. - PubMed
    1. Grubmüller B, Senn D, Kramer G, et al. . Response assessment using 68Ga-PSMA ligand PET in patients undergoing 177Lu-PSMA radioligand therapy for metastatic castration-resistant prostate cancer. Eur J Nucl Med Mol Imaging. 2019;46:1063–1072. - PMC - PubMed
    1. Clark MS, Packard AT, Johnson DR, Johnson GB. Pitfalls of a mixed metabolic response at PET/CT. Radiographics. 2019;39:1461–1475. - PubMed

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