The purpose of this study is to compare the effects of ablative therapy (radiation or surgery) to all sites of disease combined with standard treatments on prostate cancer, compared to the standard or usual treatments used to treat this disease.
The standard or usual treatment for this disease is systemic therapy, which includes androgen deprivation therapy (ADT) with or without chemotherapy or hormone therapy. Additionally, for some patients with specific disease features, standard treatment may also include ablative treatment (radiation or surgery) of the prostate gland if this was not completed prior to enrolling into this study. Ablative Therapy is a procedure used to destroy cancer cells and tissue. In this study Stereotactic Body Radiation Therapy (SBRT) or surgery will be used to destroy prostate cancer metastases. It is not clear if ablative therapy (SBRT or surgery) to all sites of disease used in combination with standard systemic therapy can offer better results than standard treatment alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
409
Undergo stereotactic radiotherapy and/or surgery to all sites of disease (oligometastases and primary prostate if previously untreated).
Patients continue to receive their current planned systemic therapy at the discretion of the treating physician
BCCA - Victoria
Victoria, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Failure-free Survival
defined as the time from randomization to the time of the first occurrence.
Time frame: 12 years
Radiographic Progression-free Survival
the comparison of these outcomes between the two treatment arms will be tested by the log-rank test
Time frame: 12 years
Incidence of new metastases as first event
the comparison of these outcomes between the two treatment arms will be tested by the log-rank test
Time frame: 12 years
Overall Survival
the comparison of these outcomes between the two treatment arms will be tested by the log-rank test
Time frame: 12 years
Ablative treatment related adverse events (>/= grade 3) using CTCAE v5.0
Time frame: 12 years
Quality of Life measured by EORTC QLQ-C30
It consists of both multi-item scales and single item measures, including five functioning domains, a global quality of life domain, three symptom domains and six single items. For each domain or single item measure a linear transformation will be applied to standardize the raw score to range between 0 and 100
Time frame: 12 years
Quality of Life measured by Bone Metastases module (BM22)
The BM22 has 22 questions consisting of the 4 subscales (painful sites (PS) and pain characteristics (PC) on the symptom scale and functional interference (FI) and psychosocial aspects (PA) on the functional scale). Modules, relevant subscales will also be linear transformed to standardize the raw score to range between 0 and 100 in accordance with the EORTC scoring manuals.
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QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Health Sciences North
Greater Sudbury, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Algoma District Cancer Program
Sault Ste. Marie, Ontario, Canada
...and 8 more locations
Time frame: 12 years
Quality of Life measured by prostate (PR25) questionnaire module
has 25 questions in four domains (urinary, bowel, sexual, and hormonal). Modules, relevant subscales will also be linear transformed to standardize the raw score to range between 0 and 100 in accordance with the EORTC scoring manuals.
Time frame: 6 years
Economic analysis measured by EQ-5D-5L
The robustness of the model results will be assessed using one-way and multi-way sensitivity analyses. Major drivers of medical care costs, namely hospitalization, chemotherapy and survival, will be varied ± 20%, to examine the impact on the base-case incremental cost effectiveness ratios (ICERs). Bootstrapping and the development of a cost-effectiveness acceptability curve will also be conducted.
Time frame: 12 years
Economic analysis by determining an incremental cost-effectiveness ratio reported as a difference in cost per FFS-year between the 2 arms
Time frame: 12 years