New drug combo aims to shrink aggressive prostate cancer before surgery

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Informed consent was provided before the initiation of either study procedure 2. Age between 18 and 80 years of age (including 18 and 80 years of age) 3. ECOG performance status of 0-1 points, without severe cardiovascular and psychiatric disorders 4. Histologically confirmed adenocarcinoma of the prostate 5. Any one of the following conditions: 1\) Clinical T stage ≥cT3; 2) Gleason score 8-10; 3) baseline PSA ≥20ng/ml; 4) presence of regional lymph node cN1; 6. No previous topical therapy and chemotherapy, ARi2nd 7. Patients previously treated with conventional ADT for ≤6 months (±ARi1st) 8. Subjects meet the criteria for resectability.The resectability criteria were defined as: clear lateral border of prostate and clear and non-invasive bladder neck on rectal digital examination a, and no urethral or external sphincter invasion of the prostate apex 9. The subject has not received local treatment of the primary lesion of prostate cancer in the past and has no contraindications to radical prostatectomy 10. Male subjects have undergone surgical sterilization or used acceptable contraceptive methods (defined as barrier contraception containing spermicide) during the duration of the study and 3 months after the last study drug administration to prevent their partner from getting pregnant 11. Blood donor subjects are not allowed to donate blood during the study period and during the 3 months after the last study drug administration 12. During the duration of the study (including treatment and planned visits and examinations), subjects voluntarily and able to comply with the protocol Exclusion Criteria: 1. Staff members involved in planning and/or conducting this study (research center staff). 2. Previously participated in the current study. 3. Participated in another clinical study involving an investigational product (IP) in the past month. 4. Previously underwent surgical castration or chemotherapy. 5. Previously received PARP inhibitor treatment. 6. Subjects with known hypersensitivity to ADT drugs/darolutamide or any excipient in the product. 7. Subjects with psychiatric or physical conditions that, in the investigator's judgment, would prevent them from safely receiving treatment. 8. Subjects with any laboratory test abnormalities that, in the investigator's judgment, would put them at risk if they participated in the study. 9. Subjects with persistent toxicity from prior cancer treatment (\> CTCAE Grade 2), except for alopecia. 10. Patients with known active hepatitis (i.e., hepatitis B or hepatitis C) due to the risk of bloodborne or other bodily fluid transmission. 11. Immunocompromised subjects, such as those known to be HIV seropositive. 12. Unwilling or unable to comply with protocol requirements and scheduled visits.