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 range18 Years
SexMALE
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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…