Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Urethral dose sparing and acute Radiation Oncology/ Toxicity Grading (RTOG) |
HypoCath Image Guidance with RayPilot and urethral dose sparing will result in lower grade 2+ RTOG GU acute toxicity than reported in the PACE-B trial when using a standard Linear accelerator |
To be assessed at week 12 and month 24 post completion of treatment |
|
Other |
Urethral dose sparing and acute Common Terminology for Adverse Events (CTCAE) |
HypoCath Image Guidance with RayPilot and urethral dose sparing will result in lower grade 2+ CTCAE v5.0 GU acute toxicity than reported in the PACE-B trial when using a standard Linear accelerator |
To be assessed at week 12 and month 24 post completion of treatment |
|
Other |
Urethral dose sparing late Radiation Oncology/ Toxicity Grading (RTOG) |
HypoCath Image Guidance with RayPilot and urethral dose sparing will result in lower grade 2+ RTOG GU late toxicity than reported in the PACE-B trial when using a standard Linear accelerator |
To be assessed at week 12 and month 24 post completion of treatment |
|
Other |
Urethral dose sparing late Common Terminology for Adverse Events ( CTCAE |
HypoCath Image Guidance with RayPilot and urethral dose sparing will result in lower grade 2+ CTCAE v5.0 GU late toxicity than reported in the PACE-B trial when using a standard Linear accelerator |
To be assessed at week 12 and month 24 post completion of treatment |
|
Primary |
The number of patients with acute Radiation Oncology/ Toxicity Grading (RTOG) urinary toxicity |
Clinician reported cumulative Grade 2 or worse RTOG acute GU toxicity from baseline up to 12 weeks post treatment (scale 0-4 with 0 being none increasing severity to grade 4). |
At 12 weeks post completion of treatment |
|
Primary |
The number of patients with acute Common Terminology for Adverse Events (CTCAE) urinary toxicity |
Clinician reported cumulative Grade 2 or worse CTCAE v5.0 acute GU toxicity from baseline up to 12 weeks post treatment (scale 0-5 with increasing severity to death at grade 5) |
At 12 weeks post completion of treatment |
|
Primary |
The number of patients with acute Radiation Oncology/ Toxicity Grading (RTOG) bowel toxicity |
Clinician reported cumulative Grade 2 or worse RTOG acute GI toxicity from baseline up to 12 weeks post treatment (scale 0-4 with 0 being none increasing severity to grade 4). |
At 12 weeks post treatment |
|
Primary |
The number of patients with acute Common Terminology for Adverse Events (CTCAE) bowel toxicity |
Clinician reported cumulative Grade 2 or worse CTCAE v5.0 acute GI toxicity from baseline up to 12 weeks post treatment (scale 0-5 with increasing severity to death at grade 5). |
At 12 weeks |
|
Secondary |
The number of patients with late Radiation Oncology/ Toxicity Grading (RTOG) urinary toxicity |
Clinician reported Grade 2 or worse RTOG late GU toxicity at 24 months (scale 0-4 with 0 being none increasing severity to grade 4). |
At 24 months post completion of radiotherapy treatment |
|
Secondary |
The number of patients with late Common Terminology for Adverse Events (CTCAE) urinary toxicity |
Clinician reported Grade 2 or worse CTCAE v5.0 late GU toxicity at 24 months (scale 0-5 with increasing severity to death at grade 5). |
At 24 months post completion of radiotherapy treatment |
|
Secondary |
The number of patients with late Radiation Oncology/ Toxicity Grading (RTOG) bowel toxicity |
Clinician reported Grade 2 or worse RTOG late GI toxicity at 24 months (scale 0-4 with 0 being none increasing severity to grade 4). |
At 24 months post completion of radiotherapy treatment |
|
Secondary |
The number of patients with late Common Terminology for Adverse Events (CTCAE) bowel toxicity |
Clinician reported Grade 2 or worse CTCAE v5.0 late GI toxicity at 24 months (scale 0-5 with increasing severity to death at grade 5). |
At 24 months post completion of radiotherapy treatment |
|
Secondary |
Cumulative number of patients who experienced late Radiation Oncology/ Toxicity Grading (RTOG) urinary toxicity |
Clinician reported cumulative Grade 2 or worse RTOG late GU toxicity from 6 months to 24 months post treatment (scale 0-4 with 0 being none increasing severity to grade 4). |
From 6-24 months |
|
Secondary |
Cumulative number of patients who experience late Common Terminology for Adverse Events (CTCAE) urinary toxicity |
Clinician reported cumulative Grade 2 or worse CTCAE v5.0 late GU toxicity from 6 months to 24 months post treatment (scale 0-5 with increasing severity to death at grade 5). |
From 6-24 months |
|
Secondary |
Cumulative number of patients who experience late Radiation Oncology/ Toxicity Grading (RTOG) bowel toxicity |
Clinician reported cumulative Grade 2 or worse RTOG late GI toxicity from 6 months to 24 months post treatment (scale 0-4 with 0 being none increasing severity to grade 4). |
From 6-24 months |
|
Secondary |
Cumulative number of patients who experience late Common Terminology for Adverse Events (CTCAE) bowel toxicity |
Clinician reported cumulative Grade 2 or worse CTCAEv5.0 late GI toxicity from 6 months to 24 months post treatment (scale 0-5 with increasing severity to death at grade 5). |
From 6-24 months |
|
Secondary |
Quality of life patient reported outcome measure Expanded Prostate Index Composite-26 (EPIC-26) |
Expanded Prostate Index Composite-26 (EPIC-26), patient reported outcome measure of urinary, bowel, sexual, physical and mental health |
Pre treatment to 24 months post treatment |
|
Secondary |
Quality of life patient reported outcome measure International Prostate Symptom Score (IPSS) |
International Prostate Symptom Score (IPSS), a patient reported outcome measure of urinary bother |
Pre treatment to 24 months post treatment |
|
Secondary |
Quality of life patient reported outcome measure International Index of Erectile Function-5 (IIEF-5) |
International Index of Erectile Function-5 (IIEF-5), a patient reported outcome measure of erectile and sexual function |
Pre treatment to 24 months post treatment |
|
Secondary |
Quality of life patient reported outcome measure Vaizy Score |
Vaizey score, a patient reported assessment of bowel function |
Pre treatment to 24 months post treatment |
|