FT. LAUDERDALE, FlaSlight changes in the administration of
salvage therapy after radical prostatectomy are among several
revisions to the National Comprehensive Cancer Network (NCCN)
Practice Guidelines for Prostate Cancer. The revised guidelines
recommend radiotherapy for men with positive margins whose
prostate-specific antigen (PSA) levels fail to fall to 0 ng/mL after
In a more controversial recommendation, the guidelines also urge
physicians to consider radiotherapy in men with negative
margins whose PSA levels fail to fall to 0 ng/mL. Sequential androgen
ablative therapy is recommended after salvage therapy.
With negative margins, if the PSA does not drop to 0 at a
predetermined time, usually 3 months after surgery, one should
consider adjuvant radiotherapy, even though we all realize this is
very controversial, said Julio Pow-Sang, MD, professor of
surgery, University of South Florida. Failure of the PSA to drop to 0
often indicates metastatic disease, he said.
The panel went ahead with the recommendation even as it
anxiously awaits the Southwest Oncology Group (SWOG)
randomized study of adjuvant radiotherapy in high-risk patients, he
Dr. Pow-Sang and Howard Sandler, MD, of the University of Michigan
Comprehensive Cancer Center, and chair of the RTOG genitourinary
committee, presented the revisions to the NCCN guidelines at the
Fifth Annual NCCN conference. Lawrence Baker, DO, of the University
of Michigan Comprehensive Cancer Center, chaired the prostate cancer
For men with a rising PSA after radical prostatectomy, the guidelines
offer several pathways for salvage workup and therapy, but many
choices are left to the discretion of the physician. For instance,
bone scan, biopsy, and ProstaScint (immunoscintigraphy) are all
presented as tests physicians may wish to consider, but none is
When there is an indication of biochemical failure, there is
not much concordance about when these tests should be done, Dr.
Pow-Sang said. Most of the literature is not very clear about
the value of tests.
As with the previous version of the guidelines, three options for
salvage therapy for these patients are endorsed: radiotherapy,
androgen ablation, or observation. However, in the most recent
version of the guidelines, radiotherapy is presented as the
preferred option if PSA levels rise 1 year or more after
surgery, the seminal vesicle is not involved, the Gleason score is
less than 8, and the PSA level is below 2 ng/mL.
The data over the last several years show that radiotherapy is less
effective when the PSA levels are more than 2.5 ng/mL, Dr. Pow-Sang
said. So we set a limit of 2 ng/mL as the guideline for when to
use salvage radiotherapy.
Other changes to the guidelines include the addition of a second
treatment option for men who are asymptomatic upon diagnosis and have
a life expectancy of less than 5 years.
Previous guidelines for this group recommended only that no further
workup be done until symptoms occurred. However, the newly revised
guidelines urge physicians to consider radiotherapy for
some men in this group, depending upon stage, Gleason score, PSA, and
This was inserted into the guidelines to allow for radiation
therapy in patients who would be expected to develop symptoms or have
relatively aggressive cancers even though their life expectancy might
be relatively short, Dr. Sandler said. This is expected
to be a relatively small subset of patients.
The risk categorization for men with localized disease has also been
revised somewhat. Previous guidelines defined risk of progression
based on clinical stage and Gleason score. The guidelines now
distinguish between very low risk and low
risk, based on the amount of tumor in the biopsy specimen. Less than
5% of tumor in the specimen is considered very low risk. Emerging
evidence demonstrates that the amount of disease in the specimen is
independently prognostic of progression, Dr. Sandler
Although the NCCN panel chose to express the amount of tumor in the
specimen as a percentage, that is not the only way to measure the
presence of disease. Its unclear exactly how best to
quantify that, Dr. Sandler said. Some people calculate
tumor presence based on the number of cores that are positive, while
others measure it as the percentage of involvement in the entire specimen.