Review

. 2022 Sep;25(3):388-396.

doi: 10.1038/s41391-021-00433-1. Epub 2021 Aug 6.

PROMISE: a real-world clinical-genomic database to address knowledge gaps in prostate cancer

Vadim S Koshkin^#¹, Vaibhav G Patel^#², Alicia Ali³, Mehmet A Bilen⁴, Deepak Ravindranathan⁴, Joseph J Park³, Olesia Kellezi³, Marcin Cieslik³, Justin Shaya⁵, Angelo Cabal⁵, Landon Brown⁶, Matthew Labriola⁶, Laura S Graham⁷, Colin Pritchard⁷, Abhishek Tripathi⁸, Sanober Nusrat⁸, Pedro Barata⁹, Albert Jang⁹, Shuang R Chen⁹, Rohan Garje¹⁰, Luna Acharya¹⁰, Clara Hwang¹¹, Amanda Pilling¹¹, William Oh², Tomi Jun², Divya Natesan¹, Chris Nguyen¹, Deepak Kilari¹², Michael Pierro¹², Bicky Thapa¹², Frank Cackowski¹³, Alleda Mack¹³, Elisabeth Heath¹³, Catherine H Marshall¹⁴, Scott T Tagawa¹⁵, Susan Halabi⁶, Michael T Schweizer⁷, Andrew Armstrong⁶, Tanya Dorff¹⁶, Ajjai Alva³, Rana McKay¹⁷

Affiliations

¹ Division of Hematology and Oncology, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
² Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
³ Division of Hematology and Oncology, Department of Medicine, University of Michigan, Ann Arbor, MI, USA.
⁴ Winship Cancer Institute of Emory University, Atlanta, GA, USA.
⁵ Moores Cancer Center, University of California San Diego Health, La Jolla, CA, USA.
⁶ Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC, USA.
⁷ Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
⁸ Stephenson Cancer Center, Oklahoma City, OK, USA.
⁹ Tulane Cancer Center, Tulane University, New Orleans, LA, USA.
¹⁰ Holden Comprehensive Cancer Center, Iowa City, IA, USA.
¹¹ Division of Hematology/Oncology, Department of Internal Medicine, Henry Ford Health System, Detroit, MI, USA.
¹² Department of Medicine, Medical College of Wisconsin Cancer Center, Medical College of Wisconsin, Milwaukee, WI, USA.
¹³ Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.
¹⁴ Johns Hopkins Sidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
¹⁵ Meyer Cancer Center, Weill Cornell Medicine, New York, NY, USA.
¹⁶ Department of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
¹⁷ Moores Cancer Center, University of California San Diego Health, La Jolla, CA, USA. rmckay@health.ucsd.edu.

^# Contributed equally.

PMID: 34363009
PMCID: PMC9385488
DOI: 10.1038/s41391-021-00433-1

Review

PROMISE: a real-world clinical-genomic database to address knowledge gaps in prostate cancer

Vadim S Koshkin et al. Prostate Cancer Prostatic Dis. 2022 Sep.

. 2022 Sep;25(3):388-396.

doi: 10.1038/s41391-021-00433-1. Epub 2021 Aug 6.

Authors

Affiliations

¹ Division of Hematology and Oncology, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
² Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
³ Division of Hematology and Oncology, Department of Medicine, University of Michigan, Ann Arbor, MI, USA.
⁴ Winship Cancer Institute of Emory University, Atlanta, GA, USA.
⁵ Moores Cancer Center, University of California San Diego Health, La Jolla, CA, USA.
⁶ Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC, USA.
⁷ Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
⁸ Stephenson Cancer Center, Oklahoma City, OK, USA.
⁹ Tulane Cancer Center, Tulane University, New Orleans, LA, USA.
¹⁰ Holden Comprehensive Cancer Center, Iowa City, IA, USA.
¹¹ Division of Hematology/Oncology, Department of Internal Medicine, Henry Ford Health System, Detroit, MI, USA.
¹² Department of Medicine, Medical College of Wisconsin Cancer Center, Medical College of Wisconsin, Milwaukee, WI, USA.
¹³ Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.
¹⁴ Johns Hopkins Sidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
¹⁵ Meyer Cancer Center, Weill Cornell Medicine, New York, NY, USA.
¹⁶ Department of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
¹⁷ Moores Cancer Center, University of California San Diego Health, La Jolla, CA, USA. rmckay@health.ucsd.edu.

^# Contributed equally.

PMID: 34363009
PMCID: PMC9385488
DOI: 10.1038/s41391-021-00433-1

Abstract

Purpose: Prostate cancer is a heterogeneous disease with variable clinical outcomes. Despite numerous recent approvals of novel therapies, castration-resistant prostate cancer remains lethal. A "real-world" clinical-genomic database is urgently needed to enhance our characterization of advanced prostate cancer and further enable precision oncology.

Methods: The Prostate Cancer Precision Medicine Multi-Institutional Collaborative Effort (PROMISE) is a consortium whose aims are to establish a repository of de-identified clinical and genomic patient data that are linked to patient outcomes. The consortium structure includes a (1) bio-informatics committee to standardize genomic data and provide quality control, (2) biostatistics committee to independently perform statistical analyses, (3) executive committee to review and select proposals of relevant questions for the consortium to address, (4) diversity/inclusion committee to address important clinical questions pertaining to racial disparities, and (5) patient advocacy committee to understand patient perspectives to improve patients' quality of care.

Results: The PROMISE consortium was formed by 16 academic institutions in early 2020 and a secure RedCap database was created. The first patient record was entered into the database in April 2020 and over 1000 records have been entered as of early 2021. Data entry is proceeding as planned with the goal to have over 2500 patient records by the end of 2021.

Conclusions: The PROMISE consortium provides a powerful clinical-genomic platform to interrogate and address data gaps that have arisen with increased genomic testing in the clinical management of prostate cancer. The dataset incorporates data from patient populations that are often underrepresented in clinical trials, generates new hypotheses to direct further research, and addresses important clinical questions that are otherwise difficult to investigate in prospective studies.

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Conflict of interest statement

VSK received research funding to his institution from Janssen, Nektar, Endocyte, Clovis. He has received compensation as a member of the scientific advisory board of Janssen, Clovis, Pfizer, Seattle Genetics/Astellas, Dendreon, AstraZeneca, EMD Serono. All funding received is for work performed outside the scope of this study. MAB received research funding to his institution from Xencor, Bayer, Bristol-Myers Squibb, Genentech/Roche, Seattle Genetics, Incyte, Nektar, AstraZeneca, Tricon Pharmaceuticals, Genome & Company, AAA, Peloton Therapeutics, and Pfizer. He has received compensation as a member of the scientific advisory board or as paid consultant of Exelixis, Bayer, BMS, Eisai, Pfizer, AstraZeneca, Janssen, Calithera Biosciences, Genomic Health, Nektar, and Sanofi. All funding received is for work performed outside the scope of this study. CP has consulted for AstraZaneca and received compensation for work performed outside the scope of this study. AT received research funding to his institution from EMD Serono, Aravive Inc, and Wndmil therapeutics. He has received compensation as a member of the scientific advisory board of Exilixis, EMD Serono, Genzyme, Foundation, and Pfizer. All funding received is for work performed outside the scope of this study. PB received research funding to his institution from AstraZeneca, Merck, Blue Earth Diagnostics. He has received compensation as a member of the scientific advisory board of Bristol Myers Squibb, Exelexis, Janseen, Pfizer, Sanofi, Dendreon, Caris, Bayer, EMD Serono. All funding received is for work performed outside the scope of this study. CH received research funding to his institution from AstraZeneca, Bayer, Dendreon, Merck. She has stock ownership in Johnson & Johnson. All funding received is for work performed outside the scope of this study. WO is an employee of Sema4 as Chief Medical Science Officer. He has consulted for and received funding from Amgen, Astellas, Bayer, AstraZeneca, Genzyme, Janssen, and Pfizer. All funding received is for work performed outside the scope of this study. EH received research funding to her institution from Caris. She has consulted for and received compensation from Caris. All funding received is for work performed outside the scope of this study. CHM is an employee of McGraw Hill. She has consulted for and received compensation from Dendreon and Bayer. All funding received is for work performed outside the scope of this study. STT received research funding to his institution from Sanofi, Medivation, Astellas, Janssen, rogenics, Dendreon, Newlink, Inovio, Immunomedics, Atlab, Boehringer Ingelheim, Millennium, Bayer, Merck, Abbvie, Karyopharm, Endocyte, Clovis, and Novartis. He has received personal honoraria from Sanofi, Medivation/Astellas, Dendreon, Janssen, Genentech, Bayer, Endocyte, Eisai, Immunomedics, Karyopharm, Abbvie, Tolmar, Seattle Genetics, Amgen, Clovis, QED, Pfizer, AAA/Novartis, Genomic Health, POINT Biopharma, Blue Earth Diagnostics. All funding received is for work performed outside the scope of this study. MTS received research funding to his institution from Zenith Epigenetics, Bristol Myers Squibb, Merck, Immunomedics, Janssen, AstraZeneca, Pfizer, Madison Vaccines, Tmunity and Hoffman-La Roche. He has consulted for and received compensation from Janssen and Resverlogix. All funding received is for work performed outside the scope of this study. A Armstrong received research funding to his institution from Merck, Bayer, Pfizer, Astellas, Janssen, Genentech/Roche, Constellation, Beigene, BMS, AstraZeneca. He consulted for and received compensation from Merck, Bayer, Pfizer, Astellas, Janssen, AstraZeneca, and Clovis. All funding received is for work performed outside the scope of this study. A Alva received research funding to his institution from MSD, AstraZeneca, Bristol-Myers Squibb, Astellas, Seattle Genetics, Genentech, Pfizer, Progenics, Prometheus, Eli Lilly, ASCO, Celgene, and Harpoon Therapeutics. He has received compensation as a member of the advisory board and as paid consultant for MSD, Bristol-Myers Squibb, AstraZeneca, Genentech, Roche, Pfizer, Progenics, and Prometheus. All funding received is for work performed outside the scope of this study. RM received research funding to her institution from Bayer, Pfizer, and Tempus. She has received compensation as a member of the advisory board for AstraZeneca, Bayer, Bristol Myers Squibb, Calithera, Exelixis, Janssen, Merck, Novartis, Pfizer, Sanofi, and Tempus. She consulted for and received compensation for Dendreon and Vividion. She serves on the molecular tumor board at Caris. All funding received is for work performed outside the scope of this study. VGP, A Ali, DR, JJP, OK, MC, JS, AC, LB, ML, LSG, SN, AJ, SRC, RG, LA, AP, TJ, DN, CN, DK, MP, BT, FC, AM, SH, and TD have no competing interests to disclose.

Figures

**Fig. 1. Large-scale genomic sequencing analyses of mCRPC.**
A List of three prospective genomic analyses of mCRPC samples. B Distribution of non-androgen-receptor, actionable genomic pathway alterations. C Distribution of commonly expressed and actionable genomic alterations. *Represent estimates based original article.

**Fig. 2. PROMISE consortium structure and workflow.**
A Structure consisting of administrative headquarters, bio-informatics committee, executive committee, data committee, diversity & inclusion committee, and patient advocacy committee. Responsibilities of each committed listed. B Project workflow from data collection to release of data in abstract/manuscript form.

**Fig. 3. Project milestones and future timeline.**
The PROMISE consortium was formed in March 2020. At the end of 2020, we collected clinical data of over 700 patients. We anticipate clinical data collection of 2000 patients by the end of 2021.

See this image and copyright information in PMC

References

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PROMISE: a real-world clinical-genomic database to address knowledge gaps in prostate cancer

Affiliations

PROMISE: a real-world clinical-genomic database to address knowledge gaps in prostate cancer

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous