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| Name | Class |
|---|---|
| London Health Sciences Centre | OTHER |
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This project aims to compare the changes in the urinary quality of life (QoL) following focal high dose-rate brachytherapy (HDR-BT) boost to stereotactic ablative radiotherapy (SABR), compared to standard whole gland HDR-BT boost, in the treatment of men diagnosed with intermediate- and high-risk prostate cancer, with have an identifiable DIL on mpMRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Gland High Dose Rate Brachytherapy Boost Arm | Active Comparator |
| |
| Focal High Dose Rate Brachytherapy Boost Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost | Radiation | Whole gland high dose rate brachytherapy (15 Gray/1 fraction) plus stereotactic ablative radiotherapy to the prostate +/- pelvis (25 Gray/5 fractions). Androgen deprivation therapy 6 to 24 months (physician discretion). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Urinary Quality of Life at 24 Months Measured by the Expanded Prostate Index Composite (EPIC-26) Questionnaire | To compare the impact on urinary quality of life (QoL) between focal high dose-rate brachytherapy (HDR-BT) boost and standard whole gland HDR-BT boost to stereotactic ablative radiotherapy (SABR) as reported by the participant on the Expanded Prostate Index Composite (EPIC-26) questionnaire. | From enrollment to 24 months post radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Changes in Urinary, Bowel, and Sexual Quality of Life | Less than or equal to 6 months post radiation therapy | |
| Long Term Changes in Bowel and Sexual Quality of Life Measured by Expanded Prostate Index Composite (EPIC-26) Questionnaire | Changes in bowel and sexual health as reported by the participant on the Expanded Prostate Index Composite (EPIC-26) questionnaire. |
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Inclusion Criteria:
Histologically confirmed diagnosis of adenocarcinoma of the prostate
Eastern Co-Operative Oncology Group (ECOG) 0-2
Intermediate and high-risk disease with localized unfavorable features:
Prostate volume less than or equal to 60 cc is recommended. Transrectal ultrasound (TRUS) and magnetic resonance imaging (MRI) are accepted to assess prostate volume. Patients with a prostate volume between 60 and 80 cc can be included if the International Prostate Symptom Score (IPSS) is less than 15 and brachytherapy is deemed feasible by the treating physician.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joelle Helou, MD | Contact | 519-685-8650 | Joelle.Helou@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Joelle Helou, MD | London Health Sciences Centre Research Institute, London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre, Verspeeten Family Cancer Centre | London | Ontario | N6A 5W9 | Canada |
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|
| Experimental Arm: Focal High Dose Rate Brachytherapy Boost | Radiation | Focal high dose rate brachytherapy boost to the dominant intraprostatic lesion (15 Gray/1 fraction) plus stereotactic ablative radiotherapy to the prostate (30 Gray/5 fractions) +/- the pelvis (25 Gray/5 fractions). Androgen deprivation therapy 6 to 24 months (physician discretion). |
|
| From enrollment to 24 months post radiation therapy |
| Acute and Chronic Physician-Reported Toxicity Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Severity and grade of side effects of treatment as reported by the physician using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | From enrollment to 24 months post radiation therapy |
| Prostate Specific Antigen (PSA) at 4 years | Blood test measuring the amount of PSA protein made by the prostate. | 4 years post radiation therapy |
| Biochemical Control Measure by Prostate Specific Antigen (PSA) Levels | Enrollment to 5 years post radiation therapy |
| Participant reported Symptoms Measured by the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Frequency and severity of side effects of treatment as reported by the participant on the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. | From enrollment to 24 months post radiation therapy |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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