At a glance
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A Multicenter, Prospective, Randomized Controlled Phase II Trial of PSMA PET/CT-Guided Stereotactic Body Radiotherapy Combined With Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Stereotactic Body Radiotherapy (SBRT), Darolutamide 600 mg twice daily, and 1 other intervention for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). Not yet recruiting, targeting 254 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
After a 6-month run-in period of darolutamide plus androgen deprivation therapy, eligible participants without disease progression and with residual PSMA PET/CT-positive active tumor lesions will receive PSMA PET/CT-guided stereotactic body radiotherapy to all active tumor lesions while continuing darolutamide plus androgen deprivation therapy.
After a 6-month run-in period of darolutamide plus androgen deprivation therapy, eligible participants without disease progression and with residual PSMA PET/CT-positive active tumor lesions will continue darolutamide plus androgen deprivation therapy without local radiotherapy.
Interventions
Stereotactic body radiotherapy will be delivered in the experimental arm after the 6-month run-in period of darolutamide plus androgen deprivation therapy. Radiotherapy will target all residual PSMA PET/CT-positive active tumor lesions, while participants continue darolutamide plus androgen deprivation therapy. Target lesions may include active lesions in the prostate or prostate bed and metastatic sites. Dose and fractionation will be selected according to lesion location, lesion size, and organ-at-risk constraints as specified in the study protocol.
Darolutamide will be administered orally at 600 mg twice daily with food during the 6-month run-in period in combination with androgen deprivation therapy. After randomization, darolutamide will be continued in both treatment groups according to the assigned treatment strategy. Treatment may be interrupted or dose-reduced according to protocol-defined toxicity management rules.
Androgen deprivation therapy will be maintained throughout study treatment in both groups. The method of androgen deprivation therapy will be selected by the investigator according to the participant's clinical condition and may include surgical castration or medical castration with a luteinizing hormone-releasing hormone agonist or antagonist. Treatment will aim to maintain castrate testosterone levels according to the study protocol.