NCT07649421
PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC
Not Yet Recruiting · Phase 2 · West China Hospital · registry updated 2026-09-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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 and/or pathological evidence.
- Baseline PSMA PET/CT assessment demonstrates a total of ≤20 metastatic lesions.
- No prior radical prostatectomy or radiotherapy for prostate cancer.
Exclusion
- Current or prior history of another primary malignancy.
- History of another malignancy within 3 years that differs from the study cancer in primary site or histology.
- History of papillary thyroid carcinoma is allowed if it is well controlled.
- History of basal cell carcinoma of the skin is allowed if it is well controlled.
- History of squamous cell carcinoma of the skin is allowed if it is well controlled.
- History of cervical carcinoma in situ is allowed if it is well controlled.