Clinical Trial 23679

• Overview

  Study Title:

  The Phase III "High Five Trial" Five Fraction Radiation for High-Risk Prostate Cancer

  Summary:

  This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

  Objective:

  Primary: *To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (SBRT) to those randomized to moderate hypofractionation and conventional fractionation Secondary: *To compare physician-reported toxicity as measured by CTCAE v5 between treatment arms *To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary function (assessed by EPIC-26 urinary domains) *To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported bowel function (assessed by EPIC-26 bowel domain) *To compare patient-reported fatigue (assessed by PROMIS-Fatigue) between treatment arms *To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity (COST)) between treatment arms *To compare failure-free survival between treatment arms *To compare metastasis-free survival based on molecular imaging between treatment arms *To compare overall survival between treatment arms

• Treatments

  Therapies:

  Radiotherapy

  Medications:

  Radiotherapy ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
  • High-risk disease as defined within the protocol.
  • 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
  • No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute
  • Age >= 18
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • No prior radical prostatectomy
  • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone [LHRH] agonist and oral anti-androgen) is => Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy

• Exclusion Criteria

  Key Exclusion Criteria:
  • Not meeting the inclusion criteria.

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