CHICAGO--Prostate cancer experts continue to seek other forms of therapy because the two major treatments--radiotherapy and radical pros-tatectomy--do not always reliably eradicate malignant cells.
CHICAGO--When physicians squared off on the issue of brachytherapy (interstitial radioactive seed placement) for prostate cancer at the Prostate Cancer Shootout II conference, the lines could not have been drawn more clearly.
In 1941, Charles Huggins, Clarence Hodges, and R. E. Stevens reported on the beneficial effects
of orchiectomy in 21 men with advanced prostate cancer. Fifty-five years later, Southwest Oncology Group (SWOG) investigators were able to confirm, in a 1,387-patient intergroup comparative trial of bilateral orchiectomy with or without flutamide (Eulexin), that we still have nothing better to offer these men. This fact alone should underscore the critical need for well-planned, well-executed clinical trials in prostate cancer. The incidence and death rates continue to rise, and even today too few men are being enrolled in studies designed to alter these statistics.
The Prostate Cancer Intervention Versus Observation Trial (PIVOT) is a randomized trial designed to determine whether radical prostatectomy or expectant management provides superior length and quality of life for men with clinically localized prostate cancer. Conducted at Department of Veterans Affairs and National Cancer Institute medical centers, PIVOT will enroll over 1,000 individuals less than 75 years of age. The primary study end point is all-cause mortality. Secondary outcomes include prostate cancer- and treatment-specific morbidity and mortality, health status, predictors of disease-specific outcomes, and cost-effectiveness. Within the first 3 years of enrollment, over 400 men have been randomized. Early analysis of participants' baseline characteristics indicate that enrollees are representative of men diagnosed with clinically localized prostate cancer throughout the United States. Therefore, results of PIVOT will be generalizable. These results are necessary in order to determine the preferred therapy for clinically localized prostate cancer. [ONCOLOGY 11(8):1133-1143, 1997]
No difference in the rates of biochemical failure was found between patients with stage T1 or T2 prostate cancer and a prostate-specific antigen (PSA) level of up to 10 ng/mL treated with radical prostatectomy and those treated with radiation
The Prostate Cancer Intervention Versus Observation Trial (PIVOT) should prove interest
ing in that the study design will permit observation of the natural history of a potentially lethal malignant disease, influenced only by palliative treatments. My comments will focus on the concerns raised by this study design. I will not address possible biases of the trial introduced by: (1) enrollment of less than 20% of the eligible population; (2) an enrollment rate per participating center of less than 3 patients per year; (3) a 7-year enrollment period; and (4) a 12-year follow-up (for a total trial duration of 19 years).
As described by Wilt et al in their review, the Prostate Cancer Intervention Versus Observation
Trial (PIVOT) is asking very important questions about the effect of surgical treatment vs observation, with delayed androgen deprivation available to both groups, in patients with localized prostate cancer. Clinicians who have suffered with the old Uro-Oncology Trial comparison of prostatectomy vs radiation hope that PIVOT provides answers rather than confusion.
NEW ORLEANS--More evidence that diet may affect prostate cancer came from two presentations at the American Urological Association annual meeting.
PALM BEACH, Fla--With more early-stage prostate cancers being detected, and with growing demand from patients, use of brachytherapy in prostate cancer is expected to increase substantially over the next decade, John C. Blasko, MD, said at the American Brachytherapy Society meeting.
ASCO--An oral drug that blocks enzymes that appear to be fundamental for tumor spread significantly slowed the rate of rise of PSA in men with advanced hormone-refractory prostate cancer and may have the potential to increase survival, Peter Boasberg, MD, reported at the ASCO meeting.