Metastatic hormone-sensitive prostate cancer (mHSPC) with a suboptimal early response to standard androgen deprivation therapy (ADT) combined with novel hormonal therapy (NHT)
Conditions
Interventions
NHT + Comprehensive Radiotherapy Group:None
NHT + Comprehensive Radiotherapy + PARPi Group:None
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed prostate adenocarcinoma; 2. Diagnosis of metastatic hormone-sensitive prostate cancer (mHSPC), meeting at least one of the following criteria: radiographic evidence of distant metastasis (including bone or visceral metastasis); presence of metastatic disease prior to any treatment; received standard ADT combined with novel hormonal therapy (NHT) for at least 6 months; PSA nadir >0.2 ng/mL after 3–6 months of systemic therapy; PSMA-PET/CT imaging after systemic therapy reveals 1–10 identifiable metastatic lesions (bone or soft tissue) eligible for comprehensive radiotherapy; 3. Age 18–80 years; 4. ECOG performance status 0–1; expected survival time >=12 months; 5. Laboratory parameters must meet the following criteria: Hematology: ANC >=1.5×10^9/L, Hb >=9.0 g/dL, PLT >=100×10^9/L; Liver function: ALT/AST =50 mL/min (Cockcroft-Gault formula); 6. Ability to understand and sign the informed consent form, and voluntary participation in the study.
Exclusion criteria
Exclusion criteria: 1. Underwent major surgery within 4 weeks prior to enrollment; 2. Had another malignancy within 5 years prior to enrollment, except for the following: Localized low-risk prostate cancer (defined as stage <=T2b, Gleason score <=7, and PSA <=20 ng/mL at diagnosis [if measured]) who received definitive treatment and have no PSA recurrence; Malignancies expected to be curable after treatment (including, but not limited to, adequately treated thyroid cancer, basal or squamous cell skin carcinoma, or surgically curative-treated ductal carcinoma in situ of the breast); 3. Has any other disease, metabolic abnormality, physical examination finding, or laboratory abnormality that, in the investigator’s judgment, suggests a condition or state that makes the patient unsuitable for the study drug, may interfere with interpretation of study results, or places the patient at high risk; 4. Other severe, uncontrolled concomitant diseases that may affect protocol compliance or interfere with interpretation of results; 5. Estimated poor compliance with the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients with Deep PSA Decline at 6 Months Post-Radiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA Progression-Free Survival;Adverse Effect;Radiographic Progression-Free Survival (rPFS);Metastasis-Free Survival;Time to Change in Treatment Strategy; | — |
Countries
China
Contacts
Public ContactLi Hongzhen
Peking University First Hospital
Outcome results
None listed