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Prostate CancerPhase 4IUNU-PC-123NCT07677566

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

A Phase 4 study testing Darolutamide combined with 177Lu-PSMA-617 in people with Prostate Cancer and Prostate Cancer Patients, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Prostate Cancer, Prostate Cancer Patients
What is being tested?
Darolutamide combined with 177Lu-PSMA-617
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Jul 2026to 31 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • Eastern Cooperative Oncology Group (ECOG) physical condition score 0- 1
  • Primary lesion SUVmax ≥ 20.0 as assessed by PSMA-PET examination.
  • Adequate organ function: Complete Blood Count: White blood cell count (WBC) ≥ 3.0 × 10^9/L, platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 9 g/dL. Renal Function: Serum creatinine ≤ 2 × ULN. Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 1.5 × ULN. Coagulation Function: International normalized ratio (INR) < 1.5.
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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
  • Patients with a history of other malignancies within the past 5 years, except for prostate cancer, are not eligible; however, cured basal cell carcinoma or squamous cell carcinoma of the skin may be eligible
  • Patients with mental illness, mental disability, or inability to provide informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hongqian Guo contact

+86 (025)-83106666

dr.ghq@nju.edu.cn

China1 site

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu

    Hongqian Guo, +86 (025)-83106666, dr.ghq@nju.edu.cn

Other trials in China

About this study

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.

Read more

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.

Being tested
Darolutamide combined with 177Lu-PSMA-617
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Darolutamide combined with 177Lu-PSMA-617Drug

    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 groups in NCT07677566
Study groupRoleWhat they receive
Experimental ArmExperimentalNot described
Receives: Drug: Darolutamide combined with 177Lu-PSMA-617

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pCR + MRD

    pCR + MRD (pCR: Pathological Complete Response; Minimal Residual Disease (MRD) rate: defined as the proportion of patients achieving MRD among all patients; MRD is defined as postoperative pathology indicating that the longest diameter of the tumor is ≤ 5 mm)

    Measured: Screening, End of Neoadjuvant Treatment( 12 weeks after baseline)

Secondary outcomes (7)

  1. Patient Sexual Function

    The International Index of Erectile Function (IIEF-5) will be used for assessment. This scale consists of five questions, with each question scored from 0 to 5, resulting in a total score range of 0 to 25. A total score greater than 21 indicates normal erectile function; a score of 12 to 21 indicates mild erectile dysfunction; a score of 8 to 11 indicates moderate erectile dysfunction; and a score of 1 to 7 indicates severe erectile dysfunction.

    Measured: Day 1 of Cycle 1&2 ( each cycle is 6 weeks), 1 month after treatment, 3 and 6 months after treatment, 6 months until 2 years

  2. PSA Response Rate (defined as a decrease in PSA of 50% or more)

    Measured: Day 1 of Cycle 1&2 (each cycle is 6 weeks), End of Neoadjuvant Treatment (12 weeks after baseline). The last week of each month for the first 3 months after the periprocedural, thereafter the last week of every 3rd month for a total duration of 1 year

  3. PSMA Response Rate

    PSMA Response Rate: The assessment of PSMA response will be conducted using PSMA PET/CT at 6 weeks after treatment with 177Lu-PSMA-617. If all PSMA lesions have disappeared, it is classified as PSMA complete response. If the SUVmax (maximum standardized uptake value) decreases by more than 30%, it is classified as partial response. If the SUVmax increases by more than 30% or new PSMA-avid lesions appear, it is classified as disease progression. If the response does not meet the criteria for complete response, partial response, or disease progression, it is classified as stable disease.

    Measured: Screening, End of Neoadjuvant Treatment (12 weeks after baseline)

  4. 1-year biochemical recurrence-free survival, bRFS

    1-year Biochemical Recurrence-Free Survival (bRFS): Biochemical recurrence is defined as the occurrence of PSA levels exceeding 0.2 ng/ml in two consecutive tests after radical prostatectomy, with no evidence of recurrence or metastasis on imaging.

    Measured: The last week of each month for the first 3 months after the periprocedural, thereafter the last week of every 3rd month for a total duration of 1 year

  5. Perioperative Complications

    Measured: Perioperative Period

  6. Patient Quality of Life

    The FACT-P scale (39 items) will be used for assessment. This scale includes a general functional status scale (composed of four subscales: physical, social and family, emotional, and functional) and a prostate cancer-specific subscale. The total score is calculated from the general functional and prostate cancer-specific scores, with a range from 0 to 156; a higher score indicates better functional status.

    Measured: Day 1 of Cycle 1&2 ( each cycle is 6 weeks), 1 month after treatment, 3 and 6 months after treatmnet,6 months until 2 years

  7. Tumor Radiation Absorbed Dose: The maximum absorbed dose of 177Lu-PSMA-617 treatment for the prostate (measured in Gray [Gy])

    Measured: Screening, End of Neoadjuvant Treatment(12 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07677566
Sponsor's protocol ID
23232
Acronym
IUNU-PC-123
Status last verified
Jun 2026
First submitted
18 Jun 2026
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Darolutamide combined with 177Lu-PSMA-617 in people with Prostate Cancer and Prostate Cancer Patients, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hongqian Guo (+86 (025)-83106666, dr.ghq@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR + MRD (time frame: Screening, End of Neoadjuvant Treatment( 12 weeks after baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07677566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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