Cancer Drug Shows Promise in Major Study for High-Risk Prostate Patients

A major clinical study has shown promising results for men facing high-risk prostate cancer, with findings that could transform how doctors treat the disease.

Research presented at the American Society of Clinical Oncology meeting in Chicago revealed that Johnson & Johnson’s cancer medication Erleada, when combined with hormone-suppressing treatment before and after prostate removal surgery, dramatically improved patient outcomes.

The comprehensive study tracked more than 2,000 patients over five years and found striking differences between treatment approaches. Men who received the combination therapy were nine times more likely to show minimal detectable cancer in their prostate during surgery compared to those who only received testosterone-blocking treatment.

Additionally, adding Erleada to the treatment plan cut the risk of cancer progression or death by 20%, according to the pharmaceutical company’s announcement.

The trial examined two different treatment timeframes. For patients receiving six months of the combined therapy before and after surgery, only 8.9% had little to no detectable cancer at the time of operation, versus just 1% of those getting hormone therapy alone.

When researchers extended the treatment to a full year before and after surgery, the benefits were even more pronounced. These patients averaged more than six years before needing additional treatment – nearly twice as long as those receiving only hormone therapy. This extended approach reduced recurrence and death risk by 29%.

“No ARPIs are approved for localized high-risk prostate cancer with either surgery or radiation. So the (data) would be paradigm changing,” said Dr. Mary-Ellen Taplin, the study’s lead researcher from Dana-Farber Cancer Institute in Boston.

The findings address a significant medical need. Johnson & Johnson reports that approximately 40% of the 330,000 Americans diagnosed annually with prostate cancer fall into the high-risk category. Currently, nearly half of patients who undergo standard prostate removal surgery and radiation experience cancer recurrence requiring further treatment.

Erleada, scientifically known as apalutamide, works by blocking cellular signals that fuel prostate cancer growth. It belongs to a medication class called androgen receptor pathway inhibitors.

“The patient benefit here is unequivocal,” said Mark Wildgust, Johnson & Johnson’s medical affairs lead for oncology, in an interview. “I think that the evidence is really showing that Erleada is adding something that we had not seen before.”

The medication received initial approval from U.S. regulators in 2018 and is currently prescribed alongside hormone treatments that suppress testosterone production, which drives prostate cancer development.

Side effects from the combination treatment remained consistent with previous research, including hot flashes, urinary incontinence and erectile dysfunction. The company noted that the safety profile was in line with earlier studies.

Johnson & Johnson announced plans to collaborate with regulatory agencies worldwide to secure approval for using this combination therapy in earlier stages of prostate cancer treatment.

Other widely prescribed medications in the same drug class include Pfizer’s Xtandi and Bayer’s Nubeqa.