NEW YORK (Reuters Health) Dec 02 - High-grade prostate cancer patients treated with a triple protocol of brachytherapy, external beam radiotherapy and hormonal therapy fare better than the published success rates for any one of those treatments, alone or with radical prostatectomy.
The finding, reported in the December issue of BJU International, is the result of a large case series from the Mount Sinai Medical Center in New York.
High grade prostate cancers with Gleason scores 8-10 often do poorly with any treatment, including radical prostatectomy, but Dr. Richard Stock and colleagues at Mount Sinai started offering these men the combination therapy in the mid 1990's.
"It was our feeling that radical prostatectomy was inadequate for high grade cancers, where there is a high risk of spreading through the capsule leaving cancer behind," Dr. Stock told Reuters Health.
"This is an approach that doesn't remove the cancer but at the same time takes advantage of a lot of the things we know to be important when we use radiation," he added.
From 1994 to 2006, 181 men with a median age of 69 and a mean PSA of 9 were treated with the triple protocol. One patient's tumor was stage T1b, and the rest were well distributed from stages T1c through T3. Sixty-seven percent of patients were Gleason 8, 29% were Gleason 9 and 4% were Gleason 10.
The protocol was typically delivered as 3 months of hormonal therapy followed by brachytherapy implantation. External beam radiotherapy started 2 months later. In this study most patients were on hormonal therapy for 9 months, but some continued to receive it for up to 2 years, as the decision was left to the discretion of referring physicians.
The key outcome measures were overall survival, freedom from biochemical failure (FBF) and freedom from distant metastasis (FDM). The Kaplan Meier graphs were used to project these data as follow-up times ranging from 24 to 150 months.
At eight years after treatment, the study found that the pretreatment PSA levels, Gleason score and seminal vesical biopsy results were significantly related to FBF (p=0.006, p=0.003 and p=0.04 respectively). Only the Gleason score was significantly related to FDM (p<0.001).>
Prostate cancer specific survival and overall survival for all 181 men were high at 87% and 79%, respectively. The Gleason score impacted cancer specific survival (p=0.003) but did not significantly alter overall survival (p=0.14).
While patients with Gleason scores 9 and 10 did far poorer than patients with Gleason score 8, Dr. Stock said he offers this treatment to all men with high grade disease, observing that patients on other treatments "do significantly worse."
"When you have a pattern of Gleason 5 at any area in the biopsy, there's a very high propensity that the cancer cells have spread into the bloodstream, even if tests for metastasis are negative. That probably accounts for the high failure rates of radical prostatectomy," Dr. Stock said.
Given the high chance of extra-prostatic disease, he said, "our current approach is 2 years of hormonal therapy rather than 9 months." Improved outcomes have been demonstrated with androgen deprivation therapy and external beam radiotherapy alone, so he reasons that adding brachytherapy to the mix should work even better.
The study does not report side effects such as lower urinary tract symptoms. Dr. Stock said his data on treatment toxicity will appear in another journal soon, and that the numbers "support its overall efficacy in the treatment of prostate cancer."
BJU Int 2009;104:1631-1636.
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