Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer (NCT03784755) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer
Canada409 participantsStarted 2019-11-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologic diagnosis/confirmation of prostate adenocarcinoma and no evidence of small cell cancer.
* Stage IV at presentation or relapse after curative intent therapy, classification per AJCC 8th edition: M1 disease with ≤ 5 metastases
* ≤ 3 metastases in any non-bone organ system
* Zoladex must commence within 12 weeks prior to randomization or within 12 weeks after randomization.
* Radiology (CT/MRI chest/abdomen/pelvis) within 42 days of randomization
* Bone scan within 42 days of randomization
* All tumours (Primary prostate and metastases) must be amenable to local ablative therapy (radiation and/or surgery).
* Age ≥ 18
* ECOG performance 0-2
* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and economics questionnaires in either English or French
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
* Patients must be medically suitable for study treatments as assessed by the appropriate specialties: medical, radiation, and surgical
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients rando…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.