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A prospective, multicenter real-world study exploring homologous recombination repair (HRR) pathway gene mutations in prostate cancer patients

A prospective, multicenter real-world study exploring homologous recombination repair (HRR) pathway gene mutations in prostate cancer patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073109
Enrollment
Unknown
Registered
2023-07-01
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

Prostate cancer

Interventions

Group of prostate cancer:No intervention

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Men aged 18-75 at the time of signing the informed consent form. 2) Agree to sign the informed consent form. 3) Histologically diagnosed prostate cancer, including prostate adenocarcinoma and other rare pathological types, such as squamous cell carcinoma, ductal adenocarcinoma, intraductal carcinoma, prostatic sarcoma, neuroendocrine carcinoma, small cell carcinoma, etc. 4) Patients must be able to provide blood samples, for patients undergoing radical prostatectomy in research center, they need to provide fresh or archived tumor tissues (formalin-fixed fresh tissues, paraffin-embedded wax blocks) or about 15 (at least 5) freshly cut unstained paraffin sections, the above blood and tissue samples are used for central DNA extraction and HRR gene testing. 5) Eastern Cooperative Oncology Group (ECOG) physical status =1.

Exclusion criteria

Exclusion criteria: 1) Active tuberculosis 2) Severe infection within 2 weeks before enrollment, including but not limited to infection complications leading to hospitalization, bacteremia or severe pneumonia 3) Known human immunodeficiency virus infection 4) Patients with untreated active hepatitis B are not allowed to enter the study 5) Patients with active hepatitis C are not eligible for enrollment 6) Have received HRR gene testing for prostate cancer previously

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
Disease free survival;Distant metastasis free survival;

Countries

China

Contacts

Public ContactJiang Haowen

Huashan Hospital, Fudan University

urology_hs@163.com+86 181 2118 6785

Outcome results

None listed

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