177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant... | NCT07677566

NCT07677566

Status Module

Name	Class
Bayer	INDUSTRY

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Experimental Arm	Experimental		Drug: Darolutamide combined with 177Lu-PSMA-617

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	Screening, End of Neoadjuvant Treatment( 12 weeks after baseline)

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Measure	Description	Time Frame
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).	From Day 1 of cycle 1 to the 30 days after study completion, an average of 1year and 4 months.

Eligibility Module

Eligibility Criteria

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)
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

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
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

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases