177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT07677566
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Darolutamide combined with 177Lu-PSMA-617 — DRUG
    177Lu-PSMA-617: Eligible participants must start receiving 177Lu-PSMA-617 within 14 days. Participants will receive a dosage of 7.4 GBq (± 10%) of 177Lu-PSMA-617, administered once every 6 weeks (± 7 days), for a total of two doses. Darolutamide: Administered at a dosage of 1200 mg orally in two divided doses with meals, starting from the first injection of 177Lu-PSMA-617 and continuing until 6 weeks after the second injection, for a total duration of 12 weeks.

Study Details

The goal of this clinical trial is to explore the efficacy and safety of darolutamide combined with 177Lu-PSMA-617 in treating high-risk localized prostate cancer patients who are scheduled to undergo radical prostatectomy. The main questions it aims to answer are: Does this combination treatment improve the pathological complete response rate (pCR)? What is the minimal residual disease (MRD) rate in these patients? What are the safety profiles and any adverse effects associated with this treatment? Researchers will compare the combination of darolutamide and 177Lu-PSMA-617 to a placebo to see if the combination is effective in treating high-risk localized prostate cancer. Participants will: Receive either darolutamide combined with 177Lu-PSMA-617 or a placebo every day for 12 weeks. Visit the clinic every 6 weeks for checkups and tests. Keep a diary of their symptoms and any side effects experienced during the treatment. Undergo imaging tests, including prostate MRI and PSMA PET/CT, before surgery and during follow-up.

Key Dates

First listed
Jul 1, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm

Primary Outcome Measure

pCR + MRD [ Time Frame: Screening, End of Neoadjuvant Treatment( 12 weeks after baseline) ]

Central Contacts

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