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Efficacy and safety of All-site Radiation therapy and Standard Of Care Therapy with or without Docetaxel for GG5 metastatic Prostate Cancer: A Ambispective Cohort Study

Efficacy and safety of All-site Radiation therapy and Standard Of Care Therapy with or without Docetaxel for GG5 metastatic Prostate Cancer: A Ambispective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112793
Enrollment
Unknown
Registered
2025-11-19
Start date
2025-11-29
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

Triplet Therapy Group:None
Quadruplet Therapy Group:None

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Initial puncture pathology or postoperative pathology confirms GS 9-10 points. 2. Patients with radiological confirmation of distant metastases. 3. Treatment regimen: all-site radiotherapy + standard systemic therapy (ADT + novel hormonal therapy ± chemotherapy). The radiotherapy protocol includes: all-site radiotherapy targeting all metastatic lesions or all residual active disease following systemic therapy. 4. Expected survival exceeding 12 months. 5. Age >= 18 years. 6. KPS >= 80 points. 7. White blood cell count >= 3.5 × 10?/L, neutrophil count >= 1.5 × 10?/L, platelet count >= 100.0 × 10?/L, haemoglobin >= 90 g/L. 8. Informed consent of the subject.

Exclusion criteria

Exclusion criteria: 1. Previous history of malignant tumors (except for tumors that have been cured for more than 5 years). 2. Previous abdominal radiotherapy. 3. Weight loss exceeding 10% within the past six months. 4. Individuals with pre-existing or concomitant bleeding disorders. 5. Active infection. 6. Clinically evident cardiac disease (e.g., drug-resistant hypertension, unstable angina pectoris, congestive heart failure at New York Heart Association [NYHA] class >= II, unstable symptomatic arrhythmia, or peripheral vascular disease at >= NYHA class II). 7. Individuals unable to provide informed consent due to psychological, familial, or social factors.

Design outcomes

Primary

MeasureTime frame
radiographic progression-free survival;Overall Survival;

Secondary

MeasureTime frame
Prostate Cancer-Specific Survival;PSA progression-free survival;Urinary symptom deterioration-free survival;Castration-Resistant Prostate Cancer-Free Survival;Prostate Cancer Treatment Function Assessment.;New anti-cancer treatment-free survival;Skeletal event-free survival;

Countries

China

Contacts

Public ContactXianshu Gao

Peking University First Hospital

gao7777@139.com+86 10 83575239

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026