Clinical trial NCT03301701: Feasibility Trial in Men With Hormone Sensitive Oligometastatic Prostate Cancer
Official title: Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hormone Sensitive Oligometastatic Prostate Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patients willing to accept their randomization
timeFrame: 2 years
Secondary outcomes:
measure: Toxicity
timeFrame: 7 years
measure: Efficacy
timeFrame: 7 years
measure: Efficacy
timeFrame: 7 years
measure: Efficacy
timeFrame: 7 years
measure: Efficacy
timeFrame: 7 years
measure: Efficacy
timeFrame: 7 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Patrick Cheung
role: PRINCIPAL_INVESTIGATOR
References: