The Eastern Cooperative Oncology Group (ECOG) has announced the launch of a phase III clinical study that will evaluate treatment strategies in selected men with prostate cancer.
The primary goal of the trial is to determine whether hormonal therapy (involving a combination of ketoconazole and hydrocortisone) or chemotherapy (involving a combination of docetaxel (Taxotere) and estramustine phosphate (Emcyt)) is more effective at delaying disease progression. This trial is designed for men with a history of prostate cancer initially treated with hormonal therapy and presently having no symptoms or clinical evidence of the cancer except for a prostate-specific antigen (PSA) that is increasing after initial hormonal therapy. Prostate-specific antigen is a substance produced within the prostate gland, and a rising PSA level may indicate the cancer is returning in patients with advanced prostate cancer. The amount of PSA detected in the blood may indicate the amount of cancer in the body.
As part of their study, the researchers will evaluate if the amount of PSA measured throughout the study period is a reliable method to determine the presence or absence of prostate cancer. The researchers will also look at the length of time it takes for PSA levels to increase and determine how that relates to an actual worsening of symptoms or the onset of new symptoms. The quality of life associated with each therapeutic approach will also be assessed.
Enrollment in the trial is presently underway, and ECOG is aiming to recruit about 600 patients. Males 18 years of age or older with confirmed prostate cancer who have been treated with hormonal therapy and present with an increasing PSA but no other evidence or symptoms related to prostate cancer are eligible for inclusion. This is an intergroup trial and the Southwest Oncology Group (SWOG) and the Cancer and Leukemia Group B (CALGB) will also participate in this trial.
Study participants will receive either a hormonal therapy regimen of ketoconazole/hydrocortisone or docetaxel/estramustine combination chemotherapy. Patients assigned to the hormonal therapy regimen will continue treatment until there is clinical evidence that the prostate cancer has returned. Patients receiving chemotherapy will continue treatment for a maximum of 18 weeks or will stop treatment earlier if there is clinical evidence that the prostate cancer has returned. Diagnostic studies and patient reports of new physical symptoms will be used to compare the ability of the two therapies to delay the cancer's progress.
Prostate cancer is the most common malignancy among men and the second leading cause of cancer death in men in the U.S. The American Cancer Society estimates that approximately 220,900 men will be diagnosed with the disease this year, and about 28,900 will die as a result of the disease.
Overall, roughly one in six American men will develop prostate cancer during his lifetime. If detected early, however, treatment can be highly effective.