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This is a single centre, interventional, randomized Phase II, two-arm prospective trial investigating if Stereotactic Body Radiotherapy (SBRT) to all sites of Oligopressive (OP) disease while remaining on current Systemic Therapy (ST) will improve biochemical control compared to Standard of Care (SoC) (which involves a change in ST) for patients with OP Castrate Resistance Prostate Cancer (CRPC).
The current standard of care for patients with metastatic Oligopressive (OP) Castrate Resistance Prostate Cancer (CRPC) is a change in Systemic Therapy (ST). We propose that Stereotactic Body Radiotherapy (SBRT) to Oligopressive sites, while maintaining patients on their current Systemic Therapy, may allow for biochemical control of disease while maintaining patient Quality of Life and avoiding the toxicities associated with changing Systemic Therapy. We have proposed an initial prospective feasibility study, followed by a larger phase II prospective study to investigate the efficacy of SBRT in Oligopressive Castrate Resistance Prostate Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Standard of Care | Active Comparator | Participants on Arm 1 - SOC will be treated as per standard of care by their treating Oncologist. In most instances, it is anticipated participants will undergo a change in Systemic Therapy (ST) (including best supportive care). The ST will be at the discretion of the Oncologist and patient, according to best practices for the patient's diagnosis and clinical scenario. Patients can receive palliative radiotherapy for standard indications at any time. |
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| Arm 2 - Experimental | Experimental | Participants on Arm 2 - Experimental will receive standard of care SBRT to oligoprogressive sites according to institutional standards while remaining on the systemic treatment prescribed by the treating oncologist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | SBRT will be delivered as per institutional standard. |
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| Measure | Description | Time Frame |
|---|---|---|
| Study Feasibility | Determine the feasibility of enrolling 21 patients patients onto a study randomizing patients to either MDT using SBRT plus remaining on current ST versus SoC (change in Systemic Therapy) by measuring the rate accrual (number of patients per month for 18 months). | Within 18 months of study activation. |
| Change in Prostate-Specific Antigen (PSA) | Assess by standard PSA blood testing if the proportion of patients having a >50% change in PSA compared to baseline (PSA50) is improved with MDT using SBRT plus remaining on current ST versus SoC. | Enrollment to 12 months post-enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Local Control of Oligopressive Lesions | Radiographic local control of the index OP lesions will be assessed by treating oncologist. | Enrollment to 12 months-post enrollment. |
| Radiographic Distant Control of Oligopressive Lesions |
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Inclusion Criteria:
Exclusion Criteria:
Participants must be male due to the disease site (prostate).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Glicksman, MD | Contact | 416-946-4501 | 4961 | rachel.glicksman@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Glicksman, MD | Princess Margaret Cancer Centre - University Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Center | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Systemic therapy | Other | Participants will receive Systemic Therapy. Participants in Arm 1 - SOC may change the Systemic Therapy throughout treatment. Participants in Arm 2 - Experimental will remain on the same Systemic Therapy throughout treatment. |
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Defined by growth of non-Oligoprogressive metastatic sites and/or the development of new sites of metastatic disease, as assessed by treating oncologist.
| Enrollment to 12-months post-enrollment. |
| Progression Free Survival (PFS) | Defined as the time from randomization to death from any cause, progression of disease, or date of last follow-up, whichever occurs first. PFS will be assessed by the treating oncologist. | Enrollment to 12-months post-enrollment. |
| Time to next Systemic Therapy | Defined as the time from when the study intervention has been commenced until commencement of any next systemic anti-cancer therapy (including a change to best supportive care) or date of last follow up, whichever occurs first, which will be assess by the treating oncologist. | Enrollment to 12-months post-enrollment. |
| Differences in Toxicity | Toxicity will be assessed to determine whether SBRT compared to SoC results in patient- and/or physician-reported toxicity differences. Toxicity will be collected using CTCAE v5.0 | Enrollment to 12-months post-enrollment. |
| Differences in Quality of Life | Quality of Life (QoL) will be assessed to determine whether SBRT compared to SoC results in patient- and/or physician-reported QoL differences. QoL will be collected using the EORTC QLQ-C30 questionnaire. | Enrollment to 12-months post-enrollment. |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |