Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients (NCT06350825) | Clinical Trial Compass
RecruitingPhase 3
Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients
China200 participantsStarted 2016-01-01
Plain-language summary
To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)
Who can participate
Age range
18 Years – 75 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.
. Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology;
. Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis);
. Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.);
. The surgeon believes the prostate can be removed;
Exclusion criteria
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.
1This trial combines surgery to remove the prostate with either two or three systemic drug therapies for metastatic prostate cancer — given that my cancer has already spread, is my doctor's view that removing the primary tumor could actually help slow things down, or is that still considered experimental at this stage?
2The trial is measuring radiographic progression-free survival, meaning how long before scans show the cancer growing — can my doctor explain what that means for my day-to-day life and whether that endpoint reflects outcomes I actually care about, like living longer or feeling better?
3Since this is a Phase 3 trial comparing triple versus dual drug therapy combined with surgery, what are the known side effects of each combination, and how might adding a third drug or the surgery itself affect my ability to tolerate treatment?
4The trial requires directly observed therapy, which could mean frequent clinic visits or close monitoring — how would that fit into my schedule, and are there travel, work, or family considerations my care team can help me think through before deciding?
5Would my doctor recommend I consider standard-of-care treatment first — such as established hormone therapy combinations without surgery — and how does my specific disease picture compare to what this trial is designed to study?
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.
What they're measuring
1
rPFS
Timeframe: 3 year
Trial details
NCT IDNCT06350825
SponsorThe First Affiliated Hospital with Nanjing Medical University