Not provided
Not provided
Not provided
Not provided
Lack of accruals
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours outside of regional pelvic nodes with no more than 3 in any organ system) and no previous treatment to prostate will be treated with intermittent androgen deprivation therapy +/- chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy or radiotherapy.
Investigators propose to do a randomized feasibility trial comparing RP vs RT to the prostate in the setting of hormone sensitive oligometastatic prostate cancer. SBRT will be used to treat all of the metastases, and this will be combined with an intermittent ADT approach. Adding systemic chemotherapy will be allowed. Given the past difficulties of randomizing patients between RP and RT in localized prostate cancer studies (like SPIRIT), investigators feel a small feasibility project is the first step. In the setting of metastatic disease, where radical treatment is not routine standard of care, we hope that patients will be more inclined to accept randomization. If patients do not accept their assigned randomization (ie they prefer RP even though they are randomized to RT, or vice versa), they will still be treated with their prostate intervention of choice and followed for their outcomes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Radical prostatectomy |
|
| Arm 2 | Active Comparator | Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical prostatectomy | Procedure | Radical prostatectomy |
| |
| HDR (19Gy) or SBRT (35-40Gy) |
| Measure | Description | Time Frame |
|---|---|---|
| Patients willing to accept their randomization | Patients willing to accept their randomization will be measured as a proportion. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Acute and late toxicities will be measured using CTCAE v4.0 and will be reported as percentages. | 7 years |
| Efficacy | Time to CRPC will be calculated using Kaplan Meier methodology. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrick Cheung | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N3M5 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Radiation |
Patients will receive HDR unless judged to medically unfit to undergo HDR brachytherapy, in which case they will receive SBRT |
|
| 7 years |
| Efficacy | Progression free survival will be calculated using Kaplan Meier methodology. | 7 years |
| Efficacy | Local control will be calculated using Kaplan Meier methodology. | 7 years |
| Efficacy | Distant control will be calculated using Kaplan Meier methodology. | 7 years |
| Efficacy | Overall survival will be calculated using Kaplan Meier methodology. | 7 years |