Radiation Therapy Oncology Group Trial 92-02, which was recently
reopened, is accruing about 50 patients a month, and will likely
meet its goal of accruing more African Americans within a few
months, Dr. Gerald Hanks, chairperson of the study, reports.
The study randomized patients with locally advanced prostate cancer
to receive flutamide (Eulexin) and goserelin acetate (Zoladex)
for 2 months before and then during radiation therapy. Half of
the patients will continue receiving Zoladex for at least 2 years
after radiation therapy ends. Local-regional control, disease-free
survival, and the effect of treatment on sexual function are being
RTOG 92-02 was reopened after a preliminary analysis of data on
already accrued patients found that African Americans seemed to
have higher pretreatment prostate specific antigen (PSA) levels.
"We want to determine if this remains the case when more
African Americans are added to the study," said Dr. Hanks.
Higher pretreatment PSA levels could indicated more aggressive
disease or a higher tumor stage, which, in turn, could require
more aggressive treatment, he said.
The accrual goal is now 1,300 patients, with 150 of those being
Race, Prostate Specific Antigen, and RTOG 94-12
Race and prostate specific antigen levels are also being studied
in the recently opened RTOG 94-12. The study is somewhat of a
departure from most RTOG studies, the group says, in that it isn't
a treatment or quality of life study. Instead, it is designed
to specifically determine the relationship between PSA levels
of prostate cancer patients, race, and socioeconomic status.
Patients eligible for the study are those with histologically
confirmed nonmetastatic prostate cancer (stages T1 to T4). Patients
should have had no previous prostate cancer surgery, radiation
therapy, hormonal manipulation, or chemotherapy.
PSA levels are taken before any treatment begins. Patients are
also asked to complete two questionnaires.
A total sample size of about 600 patients is expected.
For information on these or other RTOG protocols, please contact
Elaine Pakuris at 215-574-3195.