prostate cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1)Patients newly diagnosed with prostate cancer, pathologically confirmed as prostate adenocarcinoma. (2)According to the 2023 EAU Prostate Cancer Clinical Guidelines, the initial clinical stage at diagnosis is LAPC (locally advanced prostate cancer) or OMPC (oligometastatic prostate cancer), with SPECT showing no systemic metastasis or no more than 3 bone metastases. (3)Retrospective review of initial prostate MRI shows prostate volume >60ml, with both a senior radiologist and a senior urologist concluding that the prostate cancer severely invades surrounding organs such as the rectum or bladder, making complete resection of the primary prostate cancer and pelvic metastases impossible, or resulting in an extremely high risk of permanent urinary incontinence if resection is attempted. (4)The patient expresses willingness for RP (radical prostatectomy) and has received at least 3 cycles of preoperative A+D therapy. (5)Patients who did not undergo RP after completing A+D therapy are still included in the intention-to-treat analysis.
Exclusion criteria
Exclusion criteria: (1)Patients must be in the hormone-sensitive stage at the start of treatment, excluding m0-1CRPC (castration-resistant prostate cancer). (2)Patients with a history of surgeries such as transurethral resection of the prostate (TURP), which prevents assessment of prostate size changes before and after A+D conversion therapy. (3)Prostate biopsy results indicating neuroendocrine prostate cancer, including small cell carcinoma. (4)Patients receiving ADT alone, or ADT combined with novel endocrine therapies, or ADT combined with novel endocrine therapy and chemotherapy as other preoperative treatments. (5)Patients receiving fewer than 3 cycles of A+D therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion efficacy of preoperative ADT+Docetaxel therapy(A+D); | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in primary prostate tumor volume;positive surgical margin rate;postoperative pathological characteristics;PSA change rate;perioperative complications;urinary continence status;severe adverse events during chemotherapy; | — |
Countries
China
Contacts
The First Affiliated Hospital of Ningbo University