Results of PLATO trial published in JCO

The results of the PLATO trial have just been published in the Journal of Clinical Oncology (JCO). … READ MORE …

ASCO issues new PCO in treatment of chemotherapy-naive CRPC

ASCO has just released a new set of provisional guidance (a “provisional clinical opinion” or PCO) on the second-line treatment of men with chemotherapy-naive, castration-resistant prostate cancer (CRPC), i.e., men who are progressing on initial androgen deprivation therapy (ADT or “hormone” therapy) but who haven’t had docetaxel-based chemotherapy yet. … READ MORE …

No sign of evident clinical benefit in the Phase IV PLATO trial

According to a recent media release, there was no significant benefit for the investigational combination of enzalutamide (Xtandi) + abiraterone acetate (Zytiga) + prednisone in treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (cnmCRPC). … READ MORE …

“Final” data on abiraterone acetate in treatment of chemo-naive mCRPC

According to a media release issued on Sunday, the most recent “final” update to the COU-AA-302 trial has shown that treatment with abiraterone + prednisone provided a statistically significant overall survival benefit in the treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

FDA approves use of enzalutamide in chemotherapy-naive mCRPC

This afternoon the U.S. Food & Drug Administration approved enzalutamide (Xtandi) as a treatment for patients with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) based on the results of the PREVAIL trial. … READ MORE …

Decision about enzalutamide in chemo-naive mCRPC

According to a joint media release, issued yesterday by Medivation and Astellas, the U.S. Food & Drug Administration (FDA) has granted a priority review for the supplementary New Drug Application (sNDA) for the use of enzalutamide in the treatment of chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

More data from the PREVAIL trial of enzalutamide

Data about the results of the Phase III PREVAIL trial of enzalutamide in men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) continue to dribble out ahead of the formal presentation … READ MORE …

Abstract of presentation about the PREVAIL trial of enzalutamide in mCRPC

The American Society of Clinical Oncology (ASCO) has released the abstract of the paper by Beer et al. to be presented in full at the upcoming Genitourinary Cancers Symposium in San Francisco late next week … but it doesn’t really tell us anything new. … READ MORE …

Full PREVAIL data to be presented at GU Oncology Symposium

On October 22, Medivation and Astellas Pharma had previously announced a positive result to the PREVAIL trial of enzalutamide vs. placebo in the treatment of men with chemotherapy-naive, metastatic castration-resistant prostate cancer. … READ MORE …

Cabozantinib + abiraterone in management of chemo-naive mCRPC

According to a media release issued earlier today by Exelixis, the company has initiated a randomized Phase II clinical trial of cabozantinib + abiraterone + prednisone (CAP) versus abiraterone + prednisone (AP) in chemotherapy-naive men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Enzalutamide cuts risk of death in pre-chemotherapy mCRPC

According to a media release from Medivation and Astellas issued earlier today, the companies are stopping the randomized, double-blind, Phase III PREVAIL trial early because enzalutamide has shown a 30 percent reduction in risk of death and an 81 percent reduction in risk of radiographic progression or death in this trial. … READ MORE …

Health Canada expands clinical indications for use of Zytiga in mCRPC

According to a media release issued by Janssen, Inc. (a division of Johnson & Johnson) earlier today, Health Canada has approved the use of abiraterone acetate (Zytiga®) + prednisone for the treatment of chemotherapy-naive patients with asymptomatic or mildly symptomatic, metastatic, castration-resistant prostate cancer (mCRPC).

Barvarian Nordic provides update on randomized Phase III trial of Prostvac VF

According to a media release issued earlier today by Barvarian Nordic, the company expects to complete enrollment of patients in the randomized, double-blind, placebo-controlled, multi-center, Phase III PROSPECT trial of Prostvac VF within the next 12 months. … READ MORE …

Overall survival and rPFS data from the PREVAIL trial expected later this year

According to a media release issued by Astellas Pharma and Medivation, the companies now expect to conduct an interim analysis of the PREVAIL trial of enzalutamide (a.k.a. MDV3100 or Xtandi) for overall survival some time later this year. … READ MORE …

Adding dasatinib to docetaxel + prednisone does NOT improve OS in men with mCRPC

As one of our readers has already noted, a paper presented today at the Genitourinary Cancers Symposium did not report an overall survival benefit in the so-called READY trial. … READ MORE …