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.
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
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.
Single group
Darolutamide combined with 177Lu-PSMA-617
Drug177Lu-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.
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)
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.
PSA Response Rate (defined as a decrease in PSA of 50% or more)
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.
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.
Adverse Event
All adverse events (AEs) will be assessed and graded according to NCI-CTCAE v5.0. Safety evaluations will be conducted and recorded after the initiation of the study drug, regardless of their relationship to the study drug, until 30 days after the last study treatment or the start of new anticancer therapy (whichever occurs first).
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