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NCT02470897 · ADVERSE EVENTS

Adverse events

Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer · Source last updated 2026-10-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
up to 6 years
Other-event reporting threshold
0%

This study used modified RTOG Acute GI and GU toxicity grading to identify adverse events. Acute Toxicity were defined as occurring on treatment or within 6 weeks and Late Toxicity data was collected up to 6 years for some participants (up to 3 years for participants followed under amendment protocol).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Moderate Dose SBRT With SIB)

Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning. SBRT: 8.0Gy escalated dose Radiation Therapy Treatment Planning and Simulation: Undergo urethral-sparing IMRT planning SBRT: Undergo moderate dose SBRT with SIB

0 / 10060 / 1005 / 100
Arm B (Uniform Dose SBRT)

Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning. SBRT: 7.5Gy conventional dose Radiation Therapy Treatment Planning and Simulation: Undergo urethral-sparing IMRT planning SBRT: Undergo uniform dose SBRT

0 / 1514 / 151 / 15

Group identifiers: EG000: Arm A (Moderate Dose SBRT With SIB) · EG001: Arm B (Uniform Dose SBRT)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of moderate GI toxicities on treatment or within 6 weeks.
      organ System
      Gastrointestinal disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Acute GI Toxicity: Grade 2
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of severe GI toxicities on treatment or within 6 weeks.
      organ System
      Gastrointestinal disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Acute GI Toxicity: Grade 3
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of moderate GI toxicities greater than 90 days from completing RT.
      organ System
      Gastrointestinal disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Late GI Toxicity: Grade 2
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of severe GI toxicities greater than 90 days from completing RT.
      organ System
      Gastrointestinal disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Late GI Toxicity: Grade 3
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of moderate GU toxicities on treatment or within 6 weeks.
      organ System
      Renal and urinary disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        37
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        15
      term
      Acute GU Toxicity: Grade 2
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of severe GU toxicities on treatment or within 6 weeks.
      organ System
      Renal and urinary disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Acute GU Toxicity: Grade 3
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of moderate GU toxicities greater than 90 days from completion of RT.
      organ System
      Renal and urinary disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        44
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        10
        num At Risk
        15
      term
      Late GU Toxicity: Grade 2
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of severe GU toxicities greater than 90 days from completion of RT.
      organ System
      Renal and urinary disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Late GU Toxicity: Grade 3
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of very severe GU toxicities on treatment or within 6 weeks.
      organ System
      Renal and urinary disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        15
      term
      Acute GU Toxicity: Grade 4
    Complete source fields
    description
    This study used modified RTOG Acute GI and GU toxicity grading to identify adverse events. Acute Toxicity were defined as occurring on treatment or within 6 weeks and Late Toxicity data was collected up to 6 years for some participants (up to 3 years for participants followed under amendment protocol).
    event Groups
    1. deaths Num Affected
      5
      deaths Num At Risk
      100
      description
      Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning. SBRT: 8.0Gy escalated dose Radiation Therapy Treatment Planning and Simulation: Undergo urethral-sparing IMRT planning SBRT: Undergo moderate dose SBRT with SIB
      id
      EG000
      other Num Affected
      60
      other Num At Risk
      100
      serious Num Affected
      0
      serious Num At Risk
      100
      title
      Arm A (Moderate Dose SBRT With SIB)
    2. deaths Num Affected
      1
      deaths Num At Risk
      15
      description
      Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning. SBRT: 7.5Gy conventional dose Radiation Therapy Treatment Planning and Simulation: Undergo urethral-sparing IMRT planning SBRT: Undergo uniform dose SBRT
      id
      EG001
      other Num Affected
      14
      other Num At Risk
      15
      serious Num Affected
      0
      serious Num At Risk
      15
      title
      Arm B (Uniform Dose SBRT)
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of moderate GI toxicities on treatment or within 6 weeks.
      organ System
      Gastrointestinal disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Acute GI Toxicity: Grade 2
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of severe GI toxicities on treatment or within 6 weeks.
      organ System
      Gastrointestinal disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Acute GI Toxicity: Grade 3
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of moderate GI toxicities greater than 90 days from completing RT.
      organ System
      Gastrointestinal disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Late GI Toxicity: Grade 2
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of severe GI toxicities greater than 90 days from completing RT.
      organ System
      Gastrointestinal disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Late GI Toxicity: Grade 3
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of moderate GU toxicities on treatment or within 6 weeks.
      organ System
      Renal and urinary disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        37
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        15
      term
      Acute GU Toxicity: Grade 2
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of severe GU toxicities on treatment or within 6 weeks.
      organ System
      Renal and urinary disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Acute GU Toxicity: Grade 3
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of moderate GU toxicities greater than 90 days from completion of RT.
      organ System
      Renal and urinary disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        44
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        10
        num At Risk
        15
      term
      Late GU Toxicity: Grade 2
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of severe GU toxicities greater than 90 days from completion of RT.
      organ System
      Renal and urinary disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        15
      term
      Late GU Toxicity: Grade 3
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Incidence of very severe GU toxicities on treatment or within 6 weeks.
      organ System
      Renal and urinary disorders
      source Vocabulary
      RTOG toxicity
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        100
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        15
      term
      Acute GU Toxicity: Grade 4
    time Frame
    up to 6 years

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    Preserved source evidence · Not medical advice