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Phase III `High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer

Objective

-Metastasis-Free Survival (MFS) Based on conventional imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958). A confidence interval approach will be used adjusting for stratification factors. If the one sided 95% upper confidence limit of HR < 1.35, then the null hypothesis of inferiority will be rejected. If the 95% upper confidence limit excludes HR=1.35, then the null hypothesis of inferiority will be rejected. Cox proportional hazards models will be used to obtain unadjusted and adjusted HRs and 95% confidence intervals for the treatment effects.

Protocol #

NRG-GU013

Trial Phase:

Phase III

Principal Investigator:

Urdaneta, Alfredo

Cancer Type
  • Prostate
Study Site
  • Stony Point
  • Virginia Commonwealth University

Age >/= 18
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
High-risk disease
No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on
conventional imaging
Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with
ultrasound or other imaging modalities including MRI or CT scan

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Adult
  • Protocol Type Treatment
  • Research Study Team Melanie Hamilton, RN
    Phone: +1 804-628-7130
    Email Study Contact

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