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NCT02470897 · OUTCOME

Number of Participants Experiencing GI Late Toxicity

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Every 6 months up to 6 years

What was measured

Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost (Arm A). A late adverse event will be defined as an adverse event occurring more than 90 days from the completion of radiation therapy (RT).

Analysis population: The study was amended from 5 year to 3 year follow up, some participants were on study longer, others were lost to follow up.

Groups in this outcome

Grade 2 Toxicities: Arm A

Incidence of moderate GI toxicities greater than 90 days from completing RT.

Grade 2 Toxicities: Arm B

Incidence of moderate GI toxicities greater than 90 days from completing RT.

Grade 3 Toxicities: Arm A

Incidence of severe GI toxicities greater than 90 days from completing RT.

Grade 3 Toxicities: Arm B

Incidence of severe GI toxicities greater than 90 days from completing RT.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A100
Grade 2 Toxicities: Arm B15
Grade 3 Toxicities: Arm A100
Grade 3 Toxicities: Arm B15

Reported measurements

6 months

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A98
Grade 2 Toxicities: Arm B15
Grade 3 Toxicities: Arm A98
Grade 3 Toxicities: Arm B15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicities: Arm A1Not reportedNot reportedNot reportedNot reported
Grade 2 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
12 months

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A97
Grade 2 Toxicities: Arm B15
Grade 3 Toxicities: Arm A97
Grade 3 Toxicities: Arm B15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 2 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
18 months

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A96
Grade 2 Toxicities: Arm B12
Grade 3 Toxicities: Arm A96
Grade 3 Toxicities: Arm B12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicities: Arm A2Not reportedNot reportedNot reportedNot reported
Grade 2 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
24 months

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A95
Grade 2 Toxicities: Arm B11
Grade 3 Toxicities: Arm A95
Grade 3 Toxicities: Arm B11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicities: Arm A1Not reportedNot reportedNot reportedNot reported
Grade 2 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
30 months

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A95
Grade 2 Toxicities: Arm B11
Grade 3 Toxicities: Arm A95
Grade 3 Toxicities: Arm B11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 2 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
36 months

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A92
Grade 2 Toxicities: Arm B11
Grade 3 Toxicities: Arm A92
Grade 3 Toxicities: Arm B11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicities: Arm A1Not reportedNot reportedNot reportedNot reported
Grade 2 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
42 months

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A63
Grade 2 Toxicities: Arm B7
Grade 3 Toxicities: Arm A63
Grade 3 Toxicities: Arm B7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicities: Arm A1Not reportedNot reportedNot reportedNot reported
Grade 2 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
48 months

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A55
Grade 2 Toxicities: Arm B8
Grade 3 Toxicities: Arm A55
Grade 3 Toxicities: Arm B8
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicities: Arm A1Not reportedNot reportedNot reportedNot reported
Grade 2 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
54 months

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A47
Grade 2 Toxicities: Arm B7
Grade 3 Toxicities: Arm A47
Grade 3 Toxicities: Arm B7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 2 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
60 months

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A37
Grade 2 Toxicities: Arm B7
Grade 3 Toxicities: Arm A37
Grade 3 Toxicities: Arm B7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 2 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
72 months

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicities: Arm A16
Grade 2 Toxicities: Arm B5
Grade 3 Toxicities: Arm A16
Grade 3 Toxicities: Arm B5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 2 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm A0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicities: Arm B0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        98
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        98
      4. group Id
        OG003
        value
        15
      units
      Participants
    title
    6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        97
      4. group Id
        OG003
        value
        15
      units
      Participants
    title
    12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        96
      4. group Id
        OG003
        value
        12
      units
      Participants
    title
    18 months
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        95
      4. group Id
        OG003
        value
        11
      units
      Participants
    title
    24 months
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        95
      4. group Id
        OG003
        value
        11
      units
      Participants
    title
    30 months
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        92
      4. group Id
        OG003
        value
        11
      units
      Participants
    title
    36 months
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        63
      4. group Id
        OG003
        value
        7
      units
      Participants
    title
    42 months
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        55
      4. group Id
        OG003
        value
        8
      units
      Participants
    title
    48 months
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        47
      4. group Id
        OG003
        value
        7
      units
      Participants
    title
    54 months
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        37
      4. group Id
        OG003
        value
        7
      units
      Participants
    title
    60 months
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        16
      4. group Id
        OG003
        value
        5
      units
      Participants
    title
    72 months
denoms
  1. counts
    1. group Id
      OG000
      value
      100
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      100
    4. group Id
      OG003
      value
      15
    units
    Participants
description
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost (Arm A). A late adverse event will be defined as an adverse event occurring more than 90 days from the completion of radiation therapy (RT).
groups
  1. description
    Incidence of moderate GI toxicities greater than 90 days from completing RT.
    id
    OG000
    title
    Grade 2 Toxicities: Arm A
  2. description
    Incidence of moderate GI toxicities greater than 90 days from completing RT.
    id
    OG001
    title
    Grade 2 Toxicities: Arm B
  3. description
    Incidence of severe GI toxicities greater than 90 days from completing RT.
    id
    OG002
    title
    Grade 3 Toxicities: Arm A
  4. description
    Incidence of severe GI toxicities greater than 90 days from completing RT.
    id
    OG003
    title
    Grade 3 Toxicities: Arm B
param Type
COUNT_OF_PARTICIPANTS
population Description
The study was amended from 5 year to 3 year follow up, some participants were on study longer, others were lost to follow up.
reporting Status
POSTED
time Frame
Every 6 months up to 6 years
title
Number of Participants Experiencing GI Late Toxicity
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice