Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Quality of Life (QOL) - late bowel function as measured by the EPIC questionnaire |
Late bowel function as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) sub-domain approximately 1 year after the end of treatment. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores can then be added to come up with an overall quality of life score. |
I year post treatment (approximately 3 years and 2 months) |
|
| Secondary |
Quality of Life - acute urinary and sexual QOL as measured by the EPIC questionnaire |
Acute urinary and sexual QOL as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) urinary and sexual domains. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores can then be added to come up with an overall quality of life score. |
6 weeks post treatment (approximately 2 years and 3 months) |
|
| Secondary |
Quality of Life - acute bowel toxicity as measured by the EPIC questionnaire |
Acute bowel function as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) approximately 6 weeks after the end of treatment. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores can then be added to come up with an overall quality of life score. |
6 weeks post treatment (approximately 2 years and 3 months) |
|
| Secondary |
Quality of Life - late bowel bother as measured by the EPIC questionnaire |
Late bowel bother as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) sub-domain approximately 1 year after the end of treatment. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores can then be added to come up with an overall quality of life score. |
I year post treatment (approximately 3 years and 2 months) |
|
| Secondary |
Quality of Life - late urinary and sexual QOL as measured by the EPIC questionnaire |
Late urinary and sexual QOL as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC). The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores can then be added to come up with an overall quality of life score. |
I year post treatment (approximately 3 years and 2 months) |
|
| Secondary |
International Prostate Symptom Score (IPSS) |
International Prostate Symptom Score (IPSS) as reported by the patient at 6 weeks, 1 year, and 2 years post treatment. The IPSS is a tool used for monitoring symptoms of prostate enlargement (benign prostatic hyperplasia). There are 7 questions related to urinary function. Responses are on a scale from 0 (best) to 5 (worst). Responses are added to come up with a total score, measuring if the patient is mildly symptomatic, moderately symptomatic, or severely symptomatic. There is 1 quality of life question related to urinary symptoms. Responses are on a scale from 0 (best) to 6 (worst). |
6 weeks post treatment (approximately 2 years and 3 months), 1 year post treatment (approximately 3 years and 2 months) and 2 years post treatment (approximately 4 years and 2 months) |
|
| Secondary |
Toxicity - urinary, bowel, and sexual as measured by CTCAE version 4.0 |
Urinary, bowel, and sexual toxicity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4, at 6 weeks, 1 year, and 2 years post treatment. |
6 weeks post treatment (approximately 2 years and 3 months), 1 year post treatment (approximately 3 years and 2 months) and 2 years post treatment (approximately 4 years and 2 months) |
|
| Secondary |
Prostatic Specific Antigen (PSA) curve |
PSA curve at 4 years post-treatment. |
4 years post treatment (approximately 6 years and 2 months) |
|
| Secondary |
Prostatic Specific Antigen (PSA) Nadir |
PSA nadir at 4 years post-treatment. |
4 years post treatment (approximately 6 years and 2 months) |
|
| Secondary |
Cost Effectiveness of Hypofractionated WPRT |
Cost effectiveness analysis of the hypofractionated arm in comparison to the conventionally fractionated treatment arm. |
End of study (approximately 7 years and 2 months) |
|
| Secondary |
Overall Survival |
The time from randomization to death from any cause. |
End of study (approximately 7 years and 2 months) |
|
| Secondary |
Biochemical Failure-Free Survival |
The time from randomization to biochemical failure (based on the Phoenix definition) or death from any cause, whichever occurs first. |
End of study (approximately 7 years and 2 months) |
|
| Secondary |
Freedom from Local Failure |
The time from randomization to first local failure. |
End of study (approximately 7 years and 2 months) |
|
| Secondary |
Freedom from Regional Failure |
The time from randomization to first regional failure. |
End of study (approximately 7 years and 2 months) |
|
| Secondary |
Androgen Deprivation Therapy Free Survival |
The time from randomization to start of salvage ADT, death or last follow-up. |
End of study (approximately 7 years and 2 months) |
|
| Secondary |
Metastasis Free Survival |
The time from randomization to development of metastasis, death or last follow-up. |
End of study (approximately 7 years and 2 months) |
|
| Secondary |
Prostate Cancer Free Survival |
The time from randomization to death attributed to prostate cancer. |
End of study (approximately 7 years and 2 months) |
|
