Prostate cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the prostate, excluding small cell/neuroendocrine components. 2. Imaging suggests the presence of distant metastasis (excluding regional lymph node metastasis). 3. Patients planned to receive goserelin microspheres + NHA treatment can be enrolled, and those who will receive concurrent chemotherapy are also eligible. 4. Imaging evidence of distant metastasis. 5. Male patients aged >=18 years. 6. ECOG PS score of 0–1. 7. Patients voluntarily participate, are able to comply with regular follow-up, and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous anti-tumor treatment for prostate cancer (including endocrine therapy, chemotherapy, etc.; patients who have undergone radical prostatectomy or radical radiotherapy for prostate cancer and subsequently developed metachronous metastasis are eligible). 2. Previous diagnosis of other malignancies. 3. Life expectancy< 1 year. 4. Other severe diseases, such as unstable cardiac disease after treatment, myocardial infarction within 6 months prior to treatment, cardiac function class 3–4 (NYHA), uncontrolled hypertension (greater than 150/90 mmHg) despite treatment; severe neurological or psychiatric disorders including dementia or epilepsy; uncontrolled active infection; acute gastric ulcer; hypercalcemia; chronic obstructive pulmonary disease requiring hospitalization, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients whose PSA levels drop below 0.2 ng/mL within 6 months of starting treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients whose testosterone levels drop to below 0.7/1.7 nmol/L within 1 year of starting treatment;Time from the start of treatment to PSA90/PSA50/PSA < 0.2 ng/ml; rate of 1 - year complete response of PSA;safety;Treatment adherence; | — |
Countries
China
Contacts
Peking Cancer Hospital