Is time to biochemical failure a good surrogate endpoint for overall survival?

For many years researchers have been trying to identify so-called “surrogate” endpoints that can be used to predict overall and prostate cancer-specific survival with high accuracy. … READ MORE …

MFS as an endpoint in clinical trials

Earlier this year, two drugs (apalutamide/Erleada and enzalutamide/Xtandi) were each approved for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC) based on the use of metastasis-free survival (MFS) as the study endpoint in clinical trials. … READ MORE …

CTC levels as a surrogate endpoint for clinical trials in mCRPC

A newly published analysis of data from five major clinical trials involving > 6,000 patients has provided us with additional information about circulating tumor cell (CTC) levels as an endpoint for clinical trials. … READ MORE …

Nadir PSA predicts survival after radiation and androgen deprivation for unfavorable risk patients

The following commentary addresses the article on risk for recurrent prostate cancer that we had mentioned briefly yesterday.

If a treatment isn’t working, we want to know as quickly as possible so we can try a salvage therapy while it can still make a difference. … READ MORE …

Is overall survival a useful endpoint for evaluating therapies for intermediate-risk patients?

In a recent commentary, we looked at the utility of surrogate endpoints in evaluating therapies. … READ MORE …

So … what IS going to be “hot” at ASCO this year?

It appears that when it comes to the new data to be presented at ASCO this year, this will be the first time for several years that we don’t see some really groundbreaking new data from a large Phase III trial of some new form of therapy at one of the major meetings. But there is a lot of detail and a lot of information about new trials in development. … READ MORE …

Can the “bone scan index” act as a surrogate marker for survival?

One of the problems with clinical trials for late-stage prostate cancer today is that we commonly need to follow all patients until death before we can collect sufficiently accurate data to be certain that a particular product is or is not effective in extending patient survival. … READ MORE …

Small problem in evaluation of NX-1207 in early stage, low-risk prostate cancer

Now here’s an  embarrassing admission for a drug development company to have to make … READ MORE …

Evaluation of the real utility of new biomarkers for prostate cancer risk

There is a fascinating comment by Kattan scheduled for publication in a forthcoming issue of the new journal Urology Practice. It makes a truly critical point about whether any of the new biomarkers are actually adding significantly to what we know about how to assess risk for prostate cancer. … READ MORE …

The FDA’s “take” on pre-chemo approval of abiraterone in mCRPC

A new article in Clinical Cancer Research offers us insights into the US Food and Drug Administration’s thinking about the approval of abiraterone acetate for the treatment of chemotherapy-naive patients with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Prostate Cancer Roundtable updates national policy agenda

The Prostate Cancer Roundtable has just announced an update to its national policy agenda — to include a focus on the importance of patient-reported outcomes data affecting quality of life in trials designed with survival as the primary endpoint. … READ MORE …

Are changes in PSA kinetics potentially indicative of metastasis-free survival?

Researchers at Johns Hopkins have provided data to support the hypothesis that, in men being treated with novel, non-hormonal agents for non-metastatic, non-castrate, biochemically recurrent prostate cancer after first-line therapy, changes in PSA kinetics may be indicative of metastasis-free survival. … READ MORE …

Potential surrogate endpoints for prostate cancer-specific survival

There have been several attempts to clearly define surrogate endpoints for prostate cancer-specific survival that could be used to shorten the length of clinical trials investigating the merits of specific forms of treatment for prostate cancer. A new analysis of data from the 1,554-patient RTOG 92-02 trial has further explored two such possibilities. … READ MORE …