Clinical Trial of the Week: Treatment trial for men with localized intermediate-risk prostate cancer

By Donna Loyle, communications specialist, LIMR

Main Line Health researchers are conducting a treatment trial for men diagnosed with stage IIA-B prostate cancer. Study #NRG GU005 is a phase III clinical trial that seeks to determine the safety and efficacy of stereotactic body radiation therapy (SBRT) vs. hypofractionated intensity-modulated radiation therapy (IMRT).

SBRT is a specialized radiation therapy that sends X-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. IMRT uses linear accelerators to deliver precise radiation doses to a tumor while minimizing the dose to surrounding normal tissue.

SBRT is a specialized radiation therapy that sends X-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. IMRT uses linear accelerators to deliver precise radiation doses to a tumor while minimizing the dose to surrounding normal tissue.SBRT is a specialized radiation therapy that sends X-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. IMRT uses linear accelerators to deliver precise radiation doses to a tumor while minimizing the dose to surrounding normal tissue.

Patients are randomized into two study arms: One group undergoes IMRT once daily over less than 32 business days. The other group undergoes SBRT at least every other day over less than 12 business days. Patients must agree to follow-up care for two years after therapy.

Inclusion criteria:

  • Previously untreated localized adenocarcinoma of the prostate with the following clinical findings: clinical stage by DRE of either T1c or T2a/b (limited to one side of the gland; AJCC version 7) or cT1a-c or 2a or 2b, stage group IIA or IIB (AJCC, version 8).
  • Stages T1a-T1b eligible if patient underwent TURP previously. Gleason score must be 7(3+4) with a PSA < 20 ng/mL, or 6(3+3) with a PSA > 10 ng/mL and < 20 ng/mL; (AJCC, version 7) or group grade 1 or 2, stage group IIA or IIB (AJCC version 8).
  • Prostate volume must be < 60 cc as reported at time of biopsy or by separate measure.

To date, this study has enrolled 65 patients nationwide, four of which are from Main Line Health. The trial is available at Lankenau Medical Center and Paoli Hospital. Principal investigators are Albert DeNittis, MD, and Paul Gilman, MD. For more information, visit https://www.mainlinehealth.org/research/clinical-trials/nrg-gu005

 

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