Feasibility Trial in Men With Hormone Sensitive Oligometastatic Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer

Conditions
-----------------
Hormone Sensitive Oligometastatic Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Radical prostatectomy
* Radiation: HDR (19Gy) or SBRT (35-40Gy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide informed consent. Histologic confirmation of prostate adenocarcinoma. Stage IV disease with ≤ 5 metastases outside of the pelvis. ≤ 3 metastases in any one organ system. ECOG performance 0-1. All metastatic tumours amenable to SBRT. Patient eligible for either RP or RT to the prostate. Exclusion Criteria: Castration resistant prostate cancer. Previous RP or RT to prostate. Inability to treat all metastases with SBRT. Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, in-situ cancer, superficial bladder cancer, chronic lymphocytic leukemia or low grade lymphoma which is being observed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Radical prostatectomy | Procedure: Radical prostatectomy<br>* Radical prostatectomy<br>|
| Active Comparator: Arm 2<br>Radiotherapy | Radiation: HDR (19Gy) or SBRT (35-40Gy)<br>* Patients will receive HDR unless judged to medically unfit to undergo HDR brachytherapy, in which case they will receive SBRT<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients willing to accept their randomization | Patients willing to accept their randomization will be measured as a proportion. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |