Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic … (NCT03456843) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
United States, Australia, China190 participantsStarted 2018-03-20
Plain-language summary
This is a phase 2.5 international, multi-institution, randomized clinical trial to evaluate the potential therapeutic effect of CRP combined with the BST in men with mPCa prospectively. Such hybrid design permits the inclusion of the patients who have accrued to the phase 2 investigation to phase 3 trial, thereby decreasing the number of patients needed overall (5-7). In the initial phase 2 study, we plan to accrue 190 patients.
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:
* Histologically proven adenocarcinoma of the prostate
* Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
* Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis.
* If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET \[positron emission tomography\], bone scan and MRI, modality at the discretion of the treating physician)
* No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy, etc.)
* Give informed consent
* Prostate deemed resectable by surgeon
* Plans to start or has already started ADT no longer than 6 months prior to consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Hemoglobin (HgB) \>= 9 g/dL compatible for surgery
* Platelets \> 80,000/mcL compatible for surgery
* Aspartate aminotransferase (AST) =\< 2x upper limit of normal (ULN) compatible for surgery
* Alanine aminotransferase (ALT) =\< 2x upper limit of normal (ULN) compatible for surgery
Exclusion Criteria:
* Refuses to give informed consent
* Deemed to have unresectable disease by surgeon
* Received ADT for more than 6 months prior to consent
* Life expectancy of less than 6 months prior to consent
* Active spinal cord compression
* Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent
* Previous local t…
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.