NRG-GU005

Phase III IGRT and SBRT vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer

Objective

To determine whether stereotactic body radiation therapy (SBRT) can be shown to be superior to hypofractionated intensity-modulated radiation therapy (IMRT) in terms of genitourinary (GU) and gastrointestinal (GI) toxicity by having fewer patients that experience a minimal important decline (MID) in urinary irritation/obstructive and bowel Health Related Quality of Life (HRQOL) as measured by Expanded Prostate Cancer Index Composite (EPIC)-26 at 24 months post completion of therapy.

Study Arms

  • Active Comparator: Intensity-Modulated Radiation Therapy (IMRT)
  • Experimental: Stereotactic Body Radiation Therapy (SBRT)

Eligibility

  • Previously untreated localized adenocarcinoma of the prostate
  • Patients in active surveillance who elect to be treated are eligible if they meet protocol requirements
  • Percent of submitted positive core biopsies must be < 50% of all sextants
  • History and physical including a digital rectal exam 60 days prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 60 days prior to registration
  • MRI of pelvis within 90 days prior to registration
  • Bone scan or sodium fluoride positron emission tomography (PET) scan within 90 days prior to registration
  • Charlson modified co-morbidity score =< 3 for patients under 60 and =< 4 for patients 60 and over 21 days prior to registration
  • International prostate symptom score (IPSS) of < 15 21 days prior to registration

NCT ID

NCT03367702