Combination therapy aims to wipe out High-Risk prostate cancer before surgery
NCT ID NCT07677566
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This trial investigates whether combining a targeted radioactive drug (177Lu-PSMA-617) with a hormone therapy (darolutamide) before surgery can improve outcomes for men with high-risk localized prostate cancer. Participants receive two doses of the radioactive drug and daily hormone pills for 12 weeks, then undergo prostate removal. The study measures how many patients have no detectable cancer or only minimal residual disease in the removed tissue, and tracks side effects and sexual function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 177Lu-PSMA-617 (targeted radiation) and darolutamide (hormone therapy)
- What this could lead to
- If successful, this approach could become a standard pre-surgery treatment to eliminate more cancer cells and lower the chance of recurrence in high-risk prostate cancer.
- What could go wrong
- This is a small, early-phase study with only 20 participants, so results may not apply broadly. The combination may cause side effects like fatigue, dry mouth, or blood cell changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must be ≥ 18 and ≤75 years of age 2. All patients must have a histologically or cytologically diagnosis of prostate cancer,without distant metastasis, and suitable for radical prostatectomy 3. 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) 4. Eastern Cooperative Oncology Group (ECOG) physical condition score 0- 1 5. Primary lesion SUVmax ≥ 20.0 as assessed by PSMA-PET examination. 6. 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. 7. 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. 8. 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: 1. Patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible 2. 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 3. Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases (any M1) 4. Primary lesion SUVmax \< 20.0 as assessed by PSMA-PET examination. 5. 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 6. Patients with severe or uncontrolled concurrent infections 7. 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 8. Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection 9. 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 10. Patients with mental illness, mental disability, or inability to provide informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
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Other studies related to the condition(s) this trial covers.
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- Can a gel cushion shield the rectum during prostate radiation?