prostate cancer
Conditions
Interventions
Experimental Group:Comprehensive cytoreductive treatment (including cRP, PLND, and radiotherapy) for residual disease identified by PSMA PET after ADT plus NHT
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Male, aged 18 years and above, ECOG score 0; (2) histologically or cytologically confirmed prostate adenocarcinoma (small-cell or signet-ring cell primary prostate cancer was not allowed, but adenocarcinoma with neuroendocrine differentiation =4 bone metastases (at least one bone metastasis outside the pelvis or spine) or visceral metastases; (7) Consent to conversion therapy with ADT (GnRHa agonist or GnRHa antagonist) plus NHT (six 28-day cycles per treatment, with or without six cycles of docetaxel chemotherapy), with protocol, frequency, and dose determined by the investigator, with dose adjustment according to the label in case of adverse events. The programme includes: a) ADT+NHT b) ADT+NHT+ 6 cycles of docetaxel chemotherapy (8) agree to undergo PSMA-PET/CT reassessment within 4 to 6 weeks after the completion of six cycles of conversion therapy, and are willing to be evaluated by a multidisciplinary prostate cancer team if they meet the criteria for minimal residual prostate cancer and can tolerate further cytoreductive therapy; Patients were further treated with full-coverage local treatment (cRP and/or PLND+/- radiotherapy) for residual lesions. For surgical patients, ADT is maintained throughout the perioperative period, NHT is discontinued within 2 weeks after surgery, and NHT will be resumed after 2 weeks after surgery. Minimal residual prostate cancer was defined as the presence of 1-3 bone metastases as assessed by PSMA-PET/CT, and regional lymph node metastases (lymph node metastases in the pelvic area and below the abdominal aortic bifurcation) were allowed. For the oligo-residual lesions, the results of traditional imaging examination were available before local treatment, which were used as comparison data during follow-up after treatment. a) cRP is the standard radical prostatectomy and can be performed by open surgery, laparoscopic surgery and robotic surgery; b) PLND includes: the scope of dissection includes at least the obturator region, internal iliac region, and external iliac region; If necessary, the common iliac region and presacral region (with operable PSMA-PET/CT positive lesions) were included; c) According to the shared decision of the multidisciplinary team of prostate cancer, pelvic radiotherapy can be performed as tumor-reducing treatment, including radiotherapy to the prostate seminal vesicle and regional lymph nodes, and pelvic lymphatic drainage area; d) the definitive dose of PSMA-PET/ CT-guided radiotherapy (including conventionally fractionated and hypofractionated SBRT) for metastatic lesions based on the shared decision of the prostate cancer multidisciplinary team; e) for patients requiring pelvic radiotherapy (including the tumor bed and pelvic lymphatic drainage area) after cRP, pelvic radiotherapy was perfo
Exclusion criteria
Exclusion criteria: (1) life expectancy less than 1 year; (2) Unable to cooperate with standard treatment or follow-up due to severe mental illness or other reasons; (3) patients with other neoplastic diseases; (4) severe allergy to gonadotropin-releasing hormone (GnRH) analogues; (5) patients with immunosuppressive therapy or immunodeficiency diseases; (6) severe liver function impairment (Child-Pugh grade C); (7) Severe renal dysfunction requiring long-term dialysis; (8) severe bone marrow suppression and severe neutropenia; (9) patients could not tolerate surgery or radiotherapy; (10) Participating in other clinical studies from 30 days before enrollment until the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| radiographic progression-free survival, rPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response rate, pCR rate;time to PSA progression;overall survival, OS;After the completion of 6 cycles of conversion therapy, the proportion of patients with oligo-residual prostate cancer who could be treated with comprehensive cytoreductive treatment as assessed by the multidisciplinary team of prostate cancer;The percentage of patients achieving PSA50/PSA90 and PSA reduction to =0.2ng/ml after 6 cycles of conversion therapy. The PSA50 and PSA90 response rates were the percentages of patients who had a reduction of more than 50% and 90%, respectively, from the time before initial treatment; | — |
Countries
China
Contacts
Public ContactBin Yang
Shanghai Tenth People's Hospital
Outcome results
None listed