Proposals to Advance Prostate Cancer Research in Precision Medicine

Over the last three decades, the Prostate Cancer Foundation has facilitated key collaborations for the discovery and accelerated development of drugs and genomics that are now ubiquitous to the standard of care for patients with prostate cancer.

Foundation Medicine is deeply committed to collaborating with members of the oncology research community to advance the field, leveraging high quality real-word data sets, including the Foundation Medicine – Flatiron Health Clinico-Genomic Database (CGDB). With over 125,000 patient clinical records and outcomes linked to tumor genomic profiles, CGDB has the potential to answer questions otherwise challenging to evaluate using other available genomic data sets.

Together, the Prostate Cancer Foundation and Foundation Medicine invite oncology researchers to submit ideas where real-world data can potentially provide tangible insights that might be immediately useful for the care of patients with prostate cancer. Foundation Medicine is proud to collaborate with the Prostate Cancer Foundation and make data sources available for insight generation.

This RFC provides public notice. 
 

The purpose of this RFC is to solicit collaborative research ideas focused on the intersection of genomic testing and routine practice in the care of patients with advanced prostate cancer.

Support requests must be healthcare-related and consistent with therapeutic or technological area(s) in which Foundation Medicine, Inc is active. 
 

Foundation Medicine believes in harnessing the power of real-world data to contribute to the field by answering questions that are challenging to answer using other available data sets. Input from clinicians caring for people impacted by cancer with expertise in specific disease states results in high-impact and relevant abstracts and manuscripts. This call for proposals presumes the following approach to collaborative research:

• Oncology researchers from US institutions and practices will bring forth ideas that are reasonably able to be examined using the available data set and will meet the additional criteria described below.
• Foundation Medicine will defer to the clinical and research expertise of the awardee to direct the approved research. No patient-level data will be transferred. Awardees will work with Foundation Medicine’s Real-World Outcomes Research (RWOR) Team on statistical analysis plans and co-creation of abstracts or manuscripts, consistent with International Committee of Medical Journal Editors best practices. Together with collaborators, Foundation Medicine’s RWOR Team has published insights related to predictive biomarkers to aid clinical decisions^1-12, when, where, and how to optimally perform NGS testing in clinical practice^7,12-15, tumor evolution^3,7,8, and treatment inequities¹⁶.
• Selected projects for execution will result in insights that will be shared with the scientific and medical community via conference abstracts and peer-reviewed publications.
• No financial support will be provided to investigators for awarded projects.

The Flatiron Health-Foundation Medicine Clinico-genomic Database contains de-identified patient data from approximately 280 US cancer clinics (~800 sites of care) derived from electronic health records (EHR), linked to genomic data derived from Foundation Medicine testing¹⁷. The database currently has extensive genomic, demographic, clinical, laboratory, granular treatment timing, and survival data on over 125,000 patients. The representativeness of the database relative to the broader population of patients with cancer in the United States has previously been established by comparison to SEER¹⁸.

Examples of variables include: full variant-level data from Foundation Medicine testing, longitudinal treatment histories, socioeconomic status, longitudinal clinical and pathological features^{3,4,6,7,12,14}, and a mortality metric validated against the National Death Index to support overall survival assessments¹⁹.

Additionally, the database includes extensive liquid biopsy genomics data, including of ctDNA tumor fraction, a prognostic feature²¹ and proxy for disease burden.
 

Eligibility Criteria and Geographic Scope:

Applicants must be US-based, and actively involved in the care of people with prostate cancer or research related to genomics of prostate cancer.

Submission Instructions for RFC Proposal:

1. Applicants who meet the eligibility criteria and are interested in submitting a response to this Request for Collaboration (RFC) are encouraged to submit a feasibility assessment in CGDB prior to full submission by contacting a Medical Science Liaison for a research discussion. 
   • Contact your MSL here
     • Select ‘Research Discussion’
2. The deadline for full submission will be March 10, 2025. Please submit your submission HERE.
3. A member of the Medical Affairs team at Foundation Medicine, Inc. will email a notification of acceptance to applicants.

Award Decision Date/Mechanism: 

All received applications will undergo rigorous review by a committee including experts nominated by the Prostate Cancer Foundation as well as select Foundation Medicine scientists to ensure data fit for purpose in the Flatiron Health-Foundation Medicine Clinico-genomic Database. The below scoring criteria will be used to rank applications: 

Criteria for assessment:

• Scientific Rationale & Priors: Diligent background of clinical and biological context and rationale for the project (1-2 paragraphs, 5+ scientific references recommended).
• Hypothesis: Clear, testable, directional hypothesis. Example: we hypothesize that patients with de novo metastatic prostate cancer with SPOP mutations will have exceptionally good outcomes on 2nd generation hormonal therapy without chemotherapy compared to those without SPOP mutations, whereas this effect will not be seen with chemotherapy alone. 
• Feasibility: Fit for purpose of the Flatiron Health-Foundation Medicine Clinico-genomic Database to test the hypothesis, especially in relation to publicly available databases. While not mandatory, potential applicants to this RFC are strongly encouraged to request a feasibility assessment in CGDB prior to submission. Such a request can be submitted through the Medical Science Liaison or scientific representative and has a turnaround time of roughly one week.
• Immediacy of Impact: Clear path to tangibly and immediately improve the treatment of patients with cancer. Example: If our hypothesis is correct, patients with de novo metastatic prostate cancer and SPOP mutations might be de-risked to attempt a chemotherapy-free treatment regimen. 
• Breadth of Impact: Maximizes number of patients whose care might be improved, and potentially, the degree of benefit anticipated if hypothesis is correct.
   

There have been no pre-determined approvals. All submissions will be reviewed equally and thoroughly.
 

Applicants should not respond to this RFC unless they have read and understood the terms, purpose and requests identified below. Applicants are expected to identify and address issues that are aligned to this RFC.