177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostat… (NCT07677566) | Clinical Trial Compass
Not Yet RecruitingPhase 4
177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial
China20 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 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
. Patients must be ≥ 18 and ≤75 years of age
. All patients must have a histologically or cytologically diagnosis of prostate cancer，without distant metastasis, and suitable for radical prostatectomy
. All patients meet at least one of the following criteria： multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T2c； Gleason score of primary tumor ≥ 8； prostate specific antigen (PSA) ≥20 ng/ml； Radiographic assessment of regional lymph node metastases (N1)
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.
What they're measuring
1
pCR + MRD
Timeframe: Screening, End of Neoadjuvant Treatment( 12 weeks after baseline)
Trial details
NCT IDNCT07677566
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
. Voluntary Participation: Participants must voluntarily agree to participate and sign the informed consent form (ICF), indicating their understanding of the purpose of the study and the required procedures, as well as their willingness to participate in the research. Participants must be willing to comply with the prohibitions and restrictions outlined in the study protocol.
. Patients of childbearing potential must be willing to take high-efficiency contraceptive measures during the study period and within 120 days after the last dose of treatment
Exclusion criteria
. Patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible
. Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: prostate specific antigen (PSA) \<20 ng/mL multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor \< T3, Gleason score of primary tumor \< 8
. Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases (any M1）
. Primary lesion SUVmax \< 20.0 as assessed by PSMA-PET examination.
. Patients who have previously received androgen deprivation therapy (medical or surgical) more than 3 months or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy
. Patients with severe or uncontrolled concurrent infections
. Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration
. Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection