The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Age
40–75
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Patients must be ≥ 40 and ≤75 years of age.
All patients must have been histologically diagnozed of prostate cancer.
Metastatic disease confirmed by imaging: positive bone scan, or soft tissue or visceral metastases confirmed by abdominal/pelvic/chest contrast CT or MRI or PSMA PET-CT scan.
Participants who were treated with androgen deprivation therapy (ADT) (LHRH agonist/antagonist or orchectomy) with or without first-generation anti-androgens within 12 weeks prior to random assignment must maintain serum testosterone castration levels, i.e., ≤50 ng/dL (≤ 1.75 nmol/L) during the study period. First-generation anti-androgens must be discontinued at least 1 day before the start of study therapy.
Participants must carry one of the following DNA repair gene mutation: 1) HRR-related genes: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L; 2) Lynch syndrome-related genes: EPCAM, MLH1, MSH2, MSH6, PMS2.
Eastern Cooperative Oncology Group (ECOG) physical condition score ≤1.
Patients must have adequate hematologic function, hepatic function and renal function within 28 days prior to registration.
Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
Sexually active male subjects and their partner must agree the use of condoms as an effective contraceptive method and to avoid sperm donation during the whole treatment and within 4 weeks after the end of treatment.
You may not be if
Patients received local treatments such as pre-focal treatment,radiotherapy and palliative endoscopic resection
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.
Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
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