PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC (NCT07649421) | Clinical Trial Compass
Not Yet RecruitingPhase 2
PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC
China254 participantsStarted 2026-08-01
Plain-language summary
This is a multicenter, randomized, open-label phase 2 study for men with metastatic hormone-sensitive prostate cancer. About 254 participants will first receive 6 months of darolutamide plus androgen deprivation therapy. Participants whose cancer has not progressed and who still have active tumor lesions on prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) will then be randomly assigned to one of two groups. One group will continue darolutamide plus androgen deprivation therapy. The other group will receive stereotactic body radiotherapy (SBRT) to all active tumor lesions identified by PSMA PET/CT, while continuing darolutamide plus androgen deprivation therapy. The main purpose of this study is to find out whether adding PSMA PET/CT-guided SBRT can help participants live longer without tumor growth seen on scans or death. The study will also evaluate prostate-specific antigen (PSA) changes, time to castration-resistant prostate cancer, overall survival, side effects, and quality of life.
Who can participate
Age range
18 Years – 85 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:
* Male participants aged ≥18 years and \<85 years.
* Histologically confirmed prostate adenocarcinoma.
* No neuroendocrine carcinoma, ductal adenocarcinoma, small-cell carcinoma, signet-ring cell carcinoma, or sarcomatoid carcinoma component.
* Metastatic prostate cancer confirmed by imaging or pathological evidence.
* PSMA PET/CT and FDG PET/CT show ≤20 metastatic lesions.
* PSMA PET/CT and FDG PET/CT show concordant tracer uptake activity.
* No prior systemic or local anti-tumor treatment for prostate cancer.
* No prior androgen deprivation therapy.
* No prior first-generation antiandrogen therapy.
* No prior androgen receptor signaling inhibitor therapy, including abiraterone, enzalutamide, apalutamide, rezvilutamide, or darolutamide.
* No prior chemotherapy for prostate cancer.
* No prior radical prostatectomy.
* No prior radiotherapy for prostate cancer.
* Expected survival \>12 months.
* Able to understand the study and voluntarily sign written informed consent.
* Able and willing to comply with study visits and protocol procedures.
* Willing to provide tumor tissue, blood, and other biological samples as required by the study protocol.
* Absolute neutrophil count ≥1.5 × 10\^9/L.
* Platelet count ≥100 × 10\^9/L.
* Hemoglobin ≥90 g/L.
* Total bilirubin ≤1.5 × upper limit of normal.
* Alanine aminotransferase and aspartate aminotransferase ≤2.5 × upper limit of normal.
* Serum albumin ≥20 g/L.
* Serum creatinine ≤1.5 × upper limit of normal or creatin…
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.