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(Drug information on flutamide) (Eulexin) and goserelin(Drug information on 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 evaluated.
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 African Americans.
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.