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A Phase II Randomized Pilot Study Comparing High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy in Localized Prostate Cancer.

AIM 1: To assess differences in HRQoL in the acute and long-term setting using the Expanded Prostate Index Composite (EPIC)-26 short form. Patient-reported HRQoL scores in the bowel, sexual and urinary domains will be evaluated at baseline, 1,3,6,9,12,18,24 and 36 months. A 10-point difference between the two treatment modalities will be considered significant.

AIM 2: To assess tumor control and determine if the 36-month repeat prostate biopsy is a predictor of biochemical failure. A repeat prostate biopsy at 36 months and serial Prostate-Specific Antigen (PSA) measurements will be performed to assess local tumor control and biochemical failure, respectively. We will evaluate the predictive value of posttreatment prostate biopsy at 36 months with respect to biochemical failure.

Protocol Number: 081805
Phase: Phase II
Applicable Disease Sites: Prostate
Principal Investigator: Lara Hathout MD
Scope: Local
Therapies Involved: Radiotherapy
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
  • RWJBarnabas Health
    • Cooperman Barnabas, Livingston
  • Rutgers Cancer Institute of New Jersey-University Hospital
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.