SUNDAY, May 18 (HealthDay News) -- A therapeutic vaccine to
treat prostate cancer appears safe and may be effective, according
to the results of an early trial.
The vaccine could give hope to men with metastatic prostate
cancer by activating their immune systems to fight the disease. The
vaccine was developed to enable a patient's immune system to
produce anti-antigens and attack cancer cells, which can improve
quality of life and extend survival.
"The primary objective of the study was to determine whether or
not the vaccine was safe or whether it induced any serious adverse
events," said lead researcher Dr. David Lubaroff, director of
urology research at the University of Iowa. "The vaccine was quite
safe."
In addition, the researchers wanted to see if the vaccine
produced an immune response to prostate specific antigen (PSA).
"We found that 68 to 70 percent of the patients in the trial
demonstrated immune responses to PSA," Lubaroff said. "This was
their last resort, and we were encouraged by the fact that we could
detect any immune response in these patients."
Results of the phase 1 trial were expected to be presented
Sunday at the American Urological Association annual meeting, in
Orlando, Fla.
In the trial, Lubaroff's team tested the adenovirus/PSA vaccine
in 32 men with metastatic prostate cancer. The men were treated
with one of three different doses of the vaccine and followed for
12 months.
In addition to developing immune responses to PSA, 57 percent of
the patients survived longer than predicted. Forty-eight percent
actually doubled their expected life span. The longest survival was
almost six years, the researchers reported.
Based on these results, Lubaroff's group has started a phase II
trial, which will determine whether the immune response and
survival seen in this trial is really therapeutically meaningful in
a larger number of patients.
"If this vaccine proves to induce a strong anti-PSA immune
response, and if there is a correlation between this PSA response
and an effect on the disease, then we could use this vaccine as
another therapy," Lubaroff said.
One expert is skeptical that this vaccine will ever prove to be
a viable treatment.
"I think about all you can prove from this kind of study is
safety," said Dr. Bruce Roth, a professor of medicine and urology
at Vanderbilt University. "But that's a world of difference from
saying that there is evidence of efficacy."
Roth doesn't think changes in PSA in this kind of trial are
enough to prove the vaccine works.
"I would not take away from this that this is the breakthrough
we have been waiting for, for 35 years," Roth said. "It's an OK
theory, but we have been disappointed a lot in the past couple of
decades with immune therapies that look great but never produce the
results we had hoped for."
Another study expected to be presented Sunday showed that a PSA
reading taken between the ages of 45 and 50 actually helps predict
prostate cancer up to 30 years later. These findings suggest that
prostate cancer may start to develop very early and that PSA levels
affect the development of prostate cancer.
A third study found that black men who have a family history of
prostate cancer could benefit from a PSA reading, which could
determine their probability of developing the disease.
Black men who have known risks for prostate cancer and higher
levels of PSA are more likely to develop the disease, compared with
people in the general population.
However, black men with a family history of prostate cancer are
unlikely to develop the disease if their baseline PSA was below
what is normal for their age. The effect of family history and PSA
level actually overrode other prostate cancer risk factors, the
researchers said.
More information
For more on prostate cancer, visit the
American Cancer Society.