Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer.
Many treatment options exist for prostate cancer. One common treatment approach is to combine high-dose rate (HDR) brachytherapy (temporary insertion of radiation into the prostate) and external beam radiation. External beam radiation typically requires daily radiation treatment for three to five weeks. Improvements to radiation planning and delivery has allowed stereotactic body radiation therapy (SBRT) to be implemented in many types of cancer. SBRT has been implemented as a standard treatment option after HDR brachytherapy in response to the COVID pandemic. We are seeking to evaluate whether it is feasible to randomly assign men between SBRT (which will be five treatments of radiation or conventional radiation (3-5 weeks of daily treatment) following HDR brachytherapy
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Fractionated Radiation | Active Comparator |
|
|
| Stereotactic Body Radiotherapy | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterotactic Body Radiotherapy | Radiation | Hypofractionated stereotactic radiation treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Feasibility | The proportion of patients accepting of being randomized divided by the number of patients approached for the study. | 18mo - 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| QOL | Urinary, bowel and sexual health-related quality of life measured by the Expanded Prostate Cancer Index Composite (EPIC) domains over the study period. Each domain is normalized from 0 to 100, with a higher score indicating better outcome. | 7 years |
| Treatment Toxicity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerard Morton, MD | Contact | 416-480-6100 | 6165 | gerard.morton@sunnybrook.ca |
| Merrylee McGuffin | Contact | 416-480-6100 | 85454 | Merrylee.Mcguffin@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Gerard Morton | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventionally Fractionated Radiation | Radiation | External beam radiation therapy treatment |
|
Proportion of patients with urinary, bowel and sexual Grade 2 and 3 toxicity measured by CTCAE v5.0 throughout the study period. |
| 7 years |
| Cumulative biochemical failure | Defined as the time of enrolment to biochemical failure (based on the Phoenix definition, PSA nadir plus 2) | 7 years |
| Overall Survival | Defined as time of enrollment to death from any cause | 7 years |
| Cancer Free Survival | Defined as time of enrolment to death attributed to prostate cancer | 7 years |
| Metastasis Free Survival | Defined as time of enrolment to development of metastasis or death from any cause | 7 years |
| Freedom From Local Failure | Defined as time of enrolment to first local recurrence | 7 years |
| Freedom From Regional Failure | Defined as time of enrolment to first regional recurrence | 7 years |
| ADT Free Survival | Defined as time of enrolment to salvage ADT use or death from any cause | 7 Years |
| PSA nadir | PSA nadir at 4-years post treatment | 6 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |