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PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC

NCT07649421 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-06-16

No results posted yet for this study

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.

Conditions

  • Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Interventions

RADIATION

Stereotactic Body Radiotherapy (SBRT)

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.

DRUG

Darolutamide 600 mg twice daily

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.

DRUG

Androgen Deprivation Therapy (ADT)

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.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • West China Hospital

    lead OTHER

Principal Investigators

  • Hao Zeng, MD, PhD · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2031-08-01
Completion
2031-10-01

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07649421 on ClinicalTrials.gov