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Editorial
. 2022 Jun;33(6):574-577.
doi: 10.1016/j.annonc.2022.03.272. Epub 2022 Mar 29.

Clinical trials for metastatic castrate-resistant prostate cancer-who is looking after the control patients? Questions for the future

L C Ardolino  1 , R Dear  2 , A J Armstrong  3 , S Gillessen  4 , A M Joshua  5
Affiliations
Editorial

Clinical trials for metastatic castrate-resistant prostate cancer-who is looking after the control patients? Questions for the future

L C Ardolino et al. Ann Oncol. 2022 Jun.
No abstract available

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Conflict of interest statement

Disclosure The following represents disclosure information provided by the authors of this manuscript. All relationships are considered compensated unless otherwise noted. Financial disclosures: LCA certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (e.g. employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: AJA acknowledges the following support: Research support: (to Duke) from the NIH/NCI, PCF/Movember, DOD, Astellas, Pfizer, Bayer, Janssen, Dendreon, Genentech/Roche, BMS, AstraZeneca, Merck, Constellation, Beigene, Forma, Celgene, Amgen. Consulting or advising relationships: with Astellas, Epic Sciences, Pfizer, Bayer, Janssen, Dendreon, BMS, AstraZeneca, Merck, Forma, Celgene, Clovis, Exact Sciences. SG acknowledges the following support: Personal honoraria: for participation in advisory boards from Amgen, MSD, Orion; other honoraria from Radio-televisione Svizzera Italiana (RSI), German-speaking European School of Oncology (DESO); invited speaker for ESMO, Swiss group for Clinical Cancer Research (SAKK), Swiss Academy of Multidisciplinary oncology (SAMO), Orikata academy research group, China Anti-Cancer Association Genitourinary Oncology Committee (CACA-GU); speaker’s bureau for Janssen Cilag; travel grant from ProteoMEdiX.Institutional honoraria: for participation in advisory boards or in Independent Data Monitoring Committees and Steering Committees from AAA International, Amgen, Bayer, Bristol-Myers Squibb, Modra Pharmaceuticals, MSD, Novartis, Orion, Pfizer, Roche, Telixpharma Tolero Pharmaceutcials; other honoraria from Silvio Grasso Consulting. Patent royalties and other intellectual property: for a research method for biomarker WO2009138392. The remaining authors have declared no conflicts of interest.

Figures

Figure 1.
Figure 1.. Overall strategic design, and examples of drug development pathways in metastatic castrate resistant prostate cancer.
(A) The principle of linear drug development. An example is the TROPIC study, comparing cabazitaxel and mitoxantrone following prior docetaxel in men with metastatic castrate-resistant prostate cancer (mCRPC). A, mitoxantrone; B, best supportive care (BSC); C, cabazitaxel. (B) An example of orthogonal drug development as seen in the VISION study, comparing 177Lu-PSMA-617 and BSC following prior taxane chemotherapy and anti-androgen therapy in men with mCRPC. A, mitoxantrone; B, BSC; C, cabazitaxel; G, 177Lu-PSMA-617. (C) An example of selected drug development as seen in the PROfound study, comparing olaparib and physicians’ choice of enzalutamide or abiraterone, following abiraterone or enzalutamide, respectively, but not necessarily taxane chemotherapy in men with mCRPC and a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair. A, abiraterone; B, BSC; C, cabazitaxel; S, olaparib. (D) (i) An example of sequential multi-linear drug development as seen in many studies for advanced prostate cancer, e.g.comparing addition of various treatments to androgen deprivation therapy (ADT) in the metastatic hormone-sensitive prostate cancer (mHSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC) setting. A, trial drug; B, ADT; J, options of enzalutamide, apalutamide, darolutamide, and docetaxel. (ii) An example of serial multi-linear drug development [multi-arm, multi-stage (MAMS) type] as seen in the STAMPEDE study. A, ADT; B, zoledronic acid; C, docetaxel; D, celecoxib; E, zoledronic acid plus docetaxel; F, zoledronic acid plus celecoxib; G, abiraterone; H, radiation; J, enzalutamide plus abiraterone; K, metformin.
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References

    1. Beaver JA, Pazdur R. The wild west of checkpoint inhibitor development. N Engl J Med. 2021. 10.1056/NEJMp2116863. - DOI - PubMed
    1. de Bono J, Mateo J, Fizazi K, et al. Olaparib for metastatic castration-resistant prostate cancer. N Engl J Med. 2020;382(22):2091–2102. - PubMed
    1. Sweeny CJ, Gillessen S, Rathkopf D, et al. Abstract CT014, IMbassador250: a phase III trial comparing atezolizumab with enzalutamide vs enzalutamide alone in patients with metastatic castration-resistant prostate cancer (mCRPC). Cancer Res. 2020;80:CT014.
    1. Graff JN, Liang LW, Kim J, Stenzl A. KEYNOTE-641: a phase III study of pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer. Future Oncol. 2021;17(23):3017–3026. - PubMed
    1. Attard G, Borre M, Gurney H, et al. Abiraterone alone or in combination with enzalutamide in metastatic castration-resistant prostate cancer with rising prostate-specific antigen during enzalutamide treatment. J Clin Oncol. 2018;36:2639. - PMC - PubMed

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