Important new standards for data collection in studies of advanced prostate cancer


Recently we noted that Morgans et al. had published information about a proposed, standardized set of patient-centered outcomes data for advanced prostate cancer that would facilitate cross-comparison of data from the many trials that take now place in the management of TxNxM+ prostate cancer.

We have just had the opportunity to review the full text of this article, and we can confirm that it offers, in our opinion, an important and valuable new set of guidance regarding data that should be collected in prospective trials and in registry studies related to the management of advanced disease — although, as the authors recognize, it will ask patients to answer a lot of questions on a regular basis over time. Support group leaders and other prostate cancer educators may want to make sure that they can get hold of a copy of the full text of this article through their local medical libraries or by working with clinicians who subscribe to the journal European Urology. Here, again, is a link to the abstract.

As one might expect, most of the clinical outcomes measures that are recommended are utterly unsurprising. They include:

  • Overall survival
  • Cause-specific survival
  • Development of castration-resistant disease
  • Development of metastasis
  • Occurrence of symptomatic skeletal-related event(s)
  • Application of procedures to manage local disease progression
  • Complications associated with use of systemic therapies of all types

All of the above should be assessed at 12 months after trial initiation and annually thereafter for life.

ichom_outcome_apc_3However, it is in the area of health-related quality of life that the Advanced Prostate Cancer Working Group of the International Consortium for Health Outcomes Measurement has made a series of strong recommendations about standardization that, while hardly controversial, will require some serious reconsideration of what needs to be done as a fundamental part of the clinical trials process when it comes to the investigation of treatments for management of advanced prostate cancer.

Specifically, the working group recommends assessment of all of the following items in all patients at study initiation and at 3, 6, and 12 months after trial initiation, with ongoing annual tracking for life:

  • Performance status (based on the ECOG/WHO performance status scale)
  • Need for and use of pain medications (including OTC and stronger, prescription pain medications)
  • Pain, fatigue, physical functioning, and emotional functioning  (all tracked using the EORTC QLQ-C30 scale)
  • Urinary symptoms, bowel symptoms, hormonal symptoms, and sexual dysfunction (all tracked using the EPIC-26 scale, with additional questions related to sexual function)

To quote Morgans et al.

One of the ultimate goals … is to provide a single set of standard data that can be compared across health care systems, countries, and patient populations.

They also make the point that a reference guide complete with sample questionnaires and a data dictionary has been made freely available on the ICHOM web site as part of this initiative.

The “New” Prostate Cancer InfoLink considers that focused uptake of the applications of this set of recommendations needs to be take very seriously by all those involved in the management of trials in the field of advanced prostate cancer, and we hope that such recommendations will be endorsed by relevant organizations that include other patient organizations as well as the Prostate Cancer Foundation, the Prostate Cancer Clinical Trials Consortium, the American Urological Association, the Society of Urologic Oncology, and the American Society of Clinical Oncology.

Editorial comment: The “New” Prostate Cancer InfoLink thanks Elsevier (the publisher of European Urology) for kindly providing us with a full text copy of this important new paper.

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