The purpose of this research study is to determine if 5 (five) fractions of external radiotherapy with higher radiation doses per fraction to the pelvis leads to similar results to the standard of care external radiotherapy treatment that is comprised of 25 fractions of external radiotherapy with lower radiation doses per fraction to the pelvis. This study aims to investigate the impact in quality of life associated with hypofractionated Whole Pelvis Radiotherapy (WPRT) in comparison to conventionally-fractionated WPRT in patients with unfavorable-intermediate and high-risk prostate cancers. This information is valuable as hypofractionated WPRT is a more attractive and convenient treatment approach, and may become the new standard of care if proven to be well-tolerated and effective. Therefore, this study aims to provide a more rational justification for use of hypofractionated WPRT in future larger randomized trials by comparing this strategy with the current standard of care. This study will also provide an initial understanding of the toxicity profile and cancer control associated with hypofractionated WPRT and High Dose Rate Brachytherapy (HDR-BT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Total dose: 45 Gy in 25 fractions WPRT
Total dose: 25 Gy in 5 fractions WPRT
Tom Baker Cancer Centre
Calgary, Alberta, Canada
BC Cancer
Kelowna, British Columbia, Canada
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada
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.
Time frame: I year post treatment (approximately 3 years and 2 months)
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.
Time frame: 6 weeks post treatment (approximately 2 years and 3 months)
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.
Time frame: 6 weeks post treatment (approximately 2 years and 3 months)
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.
Time frame: I year post treatment (approximately 3 years and 2 months)
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.
Time frame: I year post treatment (approximately 3 years and 2 months)
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).
Time frame: 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)
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.
Time frame: 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)
Prostatic Specific Antigen (PSA) curve
PSA curve at 4 years post-treatment.
Time frame: 4 years post treatment (approximately 6 years and 2 months)
Prostatic Specific Antigen (PSA) Nadir
PSA nadir at 4 years post-treatment.
Time frame: 4 years post treatment (approximately 6 years and 2 months)
Cost Effectiveness of Hypofractionated WPRT
Cost effectiveness analysis of the hypofractionated arm in comparison to the conventionally fractionated treatment arm.
Time frame: End of study (approximately 7 years and 2 months)
Overall Survival
The time from randomization to death from any cause.
Time frame: End of study (approximately 7 years and 2 months)
Biochemical Failure-Free Survival
The time from randomization to biochemical failure (based on the Phoenix definition) or death from any cause, whichever occurs first.
Time frame: End of study (approximately 7 years and 2 months)
Freedom from Local Failure
The time from randomization to first local failure.
Time frame: End of study (approximately 7 years and 2 months)
Freedom from Regional Failure
The time from randomization to first regional failure.
Time frame: End of study (approximately 7 years and 2 months)
Androgen Deprivation Therapy Free Survival
The time from randomization to start of salvage ADT, death or last follow-up.
Time frame: End of study (approximately 7 years and 2 months)
Metastasis Free Survival
The time from randomization to development of metastasis, death or last follow-up.
Time frame: End of study (approximately 7 years and 2 months)
Prostate Cancer Free Survival
The time from randomization to death attributed to prostate cancer.
Time frame: End of study (approximately 7 years and 2 months)
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