APCCC19: Outcomes Research – IRONMAN Project – Preliminary Results Update

Basel, Switzerland (UroToday.com) Dr. Ian Davis briefly showed some of the progress that has been made with the IRONMAN study, an International Registry for Men with Advanced Prostate Cancer. This registry also includes molecular subtyping and patient-reported outcome measures (PROMs). The ultimate goal of this project is to provide the most elaborate description and understanding of patients with advanced prostate cancer. The project engulfs many domains including a description of treatment changes, adverse effects, PROMs, data derived from biospecimen collection and physician completed questionnaires.

As of August 2019, there have been 870 enrolled patients, with 30 screen failures, resulting in 792 remaining patients in the study, as seen in figure 1. Unfortunately, the accrual is slower than predicted, as seen in figure 2. The number of enrolled patients per country is shown in table 1, and the basic demographic and clinical data of the accrued patients so far is demonstrated in table 2.

Figure 1–IRONMAN study enrollment sites:
IRONMAN_Slide22.png
 

Figure 2–Actual accrual in the IRONMAN study:
IRONMAN_Slide24.png

Table 1–Number of enrolled patients in the IRONMAN study per country:

IRONMAN_Slide25.png
Table 2–Basic demographic and clinical data of the accrued patients so far:
IRONMAN_slide27_V2.png
Up to August 2019, there have been 2287 completed PROMs questionnaires, and 735 biospecimens have been collected at baseline with an 84% compliance rate.

Future directions for this interesting study will include developments in several directions:
  • Imaging- There is great interest from the study investigators and industry collaborators to collect archival imaging for all patients at baseline and at disease progression. Currently, this is not being done and the only thing being collected is whether an assessment of metastatic disease was done. The investigators believe it is critical to obtain the actual raw imaging scans, so these can be compared, monitored and learned from.
  • Biospecimens– Investigators are interested in the selection of a cfDNA assay platform
  • Protocol updates– The fifth amendment of the protocol is scheduled to be released at the end of 2019 or early 2020

The goal is to significantly expand the study internationally to various regions in the world. The plan is to create a significant repository of clinical, biospecimen-derived, and PROM-derived database of patients with advanced prostate cancer. The investigators aim to explore all aspects of treatment and symptoms of these patients. Moreover, understanding how physicians all over the world treat these patients, and why they decide to change treatment is a critical goal of this impressive project. The are many working groups and sub-studies that are undergoing in an attempt to explore new relevant horizons

Presented by: Ian Davis, MB BS PhD FRACP FAChPM,  a medical oncologist, cancer immunologist, clinician-scientist, and NHMRC Practitioner Fellow. Professor of Medicine, Monash University and Eastern Health, and Head of the Eastern Health Clinical School (EHCS)

Written by: Hanan Goldberg, MD, Urology Department, SUNY Upstate Medical University, Syracuse, New York, USA @GoldbergHanan  at the 2019 Advanced Prostate Cancer Consensus Conference (APCCC) #APCCC19, Aug 29 - 31, 2019 in Basel, Switzerland

Further Related Content: Movember Session: Outcomes Research - IRONMAN Project Presentation

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