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The Lancet Publishes Sylvester-LED Study Defining New Standard Of Care For Prostate Cancer Recurrence After Prostatectomy

Transforming Patient Care

Adding short-term hormone therapy and pelvic lymph node radiotherapy to the standard of care benefits patients.

Alan Pollack, M.D., Ph.D.

Adding short-term hormone therapy and pelvic lymph node radiotherapy to standard-of-care prostatectomy surgical bed treatment benefits prostate cancer patients whose prostate specific antigen (PSA) levels are rising post-prostatectomy, according to an international study led by Alan Pollack, M.D., Ph.D., chair and professor of radiation oncology at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, and published in The Lancet.

“An increasing PSA after prostatectomy for prostate cancer is a hallmark of recurrence, which occurs on average in over 50% of patients with adverse surgical pathologic findings. The PSA indicates that the cancer has returned, TRANSFORMING CANCER CARE Alan Pollack, M.D., Ph.D., led the study, which included patients in the U.S., Canada, and Israel. but not where it is coming from,” according to Dr. Pollack.

The National Cancer Institute-funded SPPORT trial was a study of men from 283 radiation oncology cancer treatment centers in the U.S. (including Sylvester), Canada and Israel, who despite having had a prostatectomy, had PSAs of between 0.1 and <2.0 ng/mL. The men were randomly selected for prostate bed radiotherapy only; prostate bed plus four to six months of hormone therapy, also known as androgen deprivation therapy; or the two therapies with the addition of pelvic lymph node radiotherapy.

The investigators focused on five-year freedom from the progression of prostate cancer as their primary outcome from the different treatment arms. They found that there was an incremental benefit with each level of treatment intensification.

The most intense treatment, which included the pelvic lymph nodes and androgen deprivation therapy, was significantly better than the other treatments. In an unplanned subgroup analysis based on the level of PSA on protocol entry, all patients — regardless of whether their PSAs were low or high — notably benefited from the addition of androgen deprivation therapy.

In the trial, five-year freedom from progression was 70.9% in the group that received prostate bed radiotherapy only, versus 81.3% among those who also received androgen deprivation therapy.

Adding pelvic lymph node treatment also resulted in a notable patient benefit to 87.4%, but that benefit was greatest for those who had higher PSAs at protocol entry.