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Therapy of metastatic hormone-sensitive prostate cancer based on molecular classification: A prospective, single-center, controlled study

Therapy of metastatic hormone-sensitive prostate cancer based on molecular classification: A prospective, single-center, controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068974
Enrollment
Unknown
Registered
2023-03-02
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

prostate cancer

Interventions

S-1 group:Androgen deprivation therapy
S-2 group:ADT plus bicalutamide
S-3 group:ADT plus second generation anti-androgens
R/I-1 group:ADT plus chemotherapy
R/I-2 group:ADT plus second generation anti-androgens
R/I-3 group:ADT and second generation anti-androgens plus chemotherapy

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult male newly diagnosed with mHSPC; 2. Histopathologic findings showed adenocarcinoma (including ductal adenocarcinoma and acinar adenocarcinoma); 3. There are enough tumor tissue specimens; 4. ECOG score 0 or 1; 5. Be willing to participate in the study and be able to comply with study requirements, including treatment and assessment of needs; 6. Sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Previously received endocrine therapy for primary prostate tumors. 2. Previous cytotoxic chemotherapy for prostate tumors. 3. Pathological findings showed that adenocarcinoma was accompanied by neuroendocrine small cell components. 4. Other malignancies are known to have progressed or require aggressive treatment. 5. Co-existing with other serious diseases, life expectancy < 12 months. 6. Have a history of dialysis or are currently on dialysis. 7. Currently participating or having participated in clinical trials studying reagents.

Design outcomes

Secondary

MeasureTime frame
Time to Castration Resistant Prostate Cancer;PSA Complete Response at 6 Months;PSA Complete Response at 12 Months;Skeletal Related Events;Time to Opioid Use;

Primary

MeasureTime frame
Time to PSA Progression;Time to Radiographic Progression;

Countries

China

Contacts

Public ContactWen Simeng

The Second Hospital of Tianjin Medical University

simeng_wen@tmu.edu.cn+86 13682104008

Outcome results

None listed

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