prostate cancer
Conditions
Interventions
Intensive Treatment:Based on real?world clinical practice, sequential intensification therapy will be administered for 6 months on the basis of ADT plus NHA. The intensification regimen in the intensi
Maintenance Treatment:Maintenance treatment with the original doublet regimen will be continued for 6 months.
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Pathologically confirmed metastatic hormone-sensitive prostate cancer (mHSPC), with failure to achieve a PSA level <0.2 ng/mL after 6–8 months of treatment with ADT plus an NHA; 3. Potential study participants should have recovered from any clinically significant adverse events related to the most recent treatment/intervention prior to enrollment; 4. Serum testosterone <1.7 nmol/L or 50 ng/dL; 5. ECOG performance status (PS) of 0–2; 6. Adequate bone marrow, hepatic, and renal function; 7. Participant consent must be obtained in accordance with applicable local and regulatory requirements. Each study participant must sign a written informed consent form prior to trial enrollment to document their willingness to participate; 8. Participants must be able to receive study treatment and complete follow-up. The investigator must ensure that enrolled participants are able to fully document treatment, adverse events, and follow-up; 9. Eligibility to receive all protocol-specified treatments must be confirmed prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. PSA >1 ng/mL after initiation of ADT, with two consecutive PSA increases at least one week apart, each representing a >50% increase from baseline; 2. Evidence of radiographic progression or clinical progression since the initiation of ADT; 3. For patients with a known history of cardiac disease, current cardiac symptoms, or prior treatment with cardiotoxic agents, cardiac function should be clinically assessed using the New York Heart Association (NYHA) functional classification. To be eligible for trial participation, patients must have NYHA Class II or higher; 4. Patients with uncontrolled comorbidities or any other significant medical conditions that, in the investigator’s judgment, would pose an unreasonable risk under this protocol; 5. Patients with prior or concurrent malignancies whose natural history or treatment would not interfere with the safety or efficacy assessment of the study are eligible for participation; 6. Receipt of a live attenuated vaccine within 30 days prior to enrollment/randomization; 7. For study participants with a history of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable under suppressive therapy if treatment is indicated; 8. Study participants with a history of hepatitis C virus (HCV) infection must have completed treatment and achieved cure. Participants currently receiving treatment for HCV infection are eligible if their HCV viral load is undetectable; 9. High-grade neuroendocrine prostate cancer or prostate cancer with small-cell features; 10.Prior chemotherapy for prostate cancer (e.g., docetaxel) or prior treatment with radiopharmaceutical agents targeting prostate cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with PSA <0.2 ng/mL at 6 months after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA 50;PSA 90; | — |
Countries
China
Contacts
Public ContactLiu Ming
Beijing Hospital
Outcome results
None listed