Genitourinary Cancers

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The FDA did not expand the indication to include patients with non-homologous recombination-repair gene-mutated castration-resistant prostate cancer.
FDA Accepts sNDA for Talazoparib/Enzalutamide in HRR-Mutant mCRPC

June 18th 2025

The FDA did not expand the indication to include patients with non–homologous recombination repair gene mutated castration-resistant prostate cancer.

A machine learning-based approach found that evaluating multiple biomarker features may identify outcomes and treatment resistance in renal cell carcinoma.
Machine Learning Approach May Predict Outcomes in RCC

June 4th 2025

The addition of CAN-2409 to a prodrug and radiation therapy in intermediate-to-high-risk prostate cancer significantly improved cancer-specific outcomes.
CAN-2409/EBRT Improves Disease-Free Survival in Localized Prostate Cancer

June 3rd 2025

Efficacy and safety outcomes in the phase 3 CONTACT-03 study were consistent regardless of prior immunotherapy or tyrosine kinase inhibitor use.
Second-Line Cabozantinib Regimens Exhibit Efficacy in Advanced RCC

June 2nd 2025

Eight votes were cast against the favorability of talazoparib and enzalutamide in the first-line setting for patients with metastatic castration-resistant prostate cancer.
ODAC Votes 8-to-0 Against First-Line Talazoparib/Enzalutamide in mCRPC

May 21st 2025

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The Prostate Cancer Intervention Versus Observation Trial (PIVOT)

August 1st 1997

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]