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MiniPDX-guided individualized treatment for patients with castration-resistant prostate cancer: a single-institution observational study

MiniPDX-guided individualized treatment for patients with castration-resistant prostate cancer: a single-institution observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060925
Enrollment
Unknown
Registered
2022-06-14
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

castration-resistant prostate cancer

Interventions

observation group:MiniPDX-guided treatment for patients with castration-resistant prostate cancer
control group:N/A

Sponsors

North China University of Science and Technology Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: a) Patients who can provide the baseline information in detail: name, age, gender, pathology and previous treatment, etc. b) Men over the age of 18 years c) ECOG score of 0-2 d) Patients who can provide samples to drug sensitivity tests; e) Life expectancy of =3 months; f) Histologically or cytologically confirmed adenocarcinoma of the prostate, excluding neuroendocrine differentiated, signet-ring cell, and small-cell carcinoma; g) Patients after surgical castration, with testosterone values < 50 ng/dL or 1.7 nmol/L; h) Disease progression (as defined by PCWG2) despite previous treatment with abiraterone and enzalutamide or second-generation ADT (Androgen-Deprivation Therapy). Disease progression defined by PCWG2 as meeting any of the following criteria: according to the rise in PSA values, at least 3 consecutive rises in PSA values at a minimum of 1-week intervals, and a baseline PSA value = 5.0 ng/ml; PSA values can be ignored as disease progression assessed by RECIST 1.1; PCWG2-defined bone metastases, i.e. = 2 new lesions presented by bone scan; i) Documented distant metastasis (based on ECT and CT/MRI), providing imaging data for disease evaluation before and after treatment, or a test report for disease evaluation provided by an experienced radiologist from Grade-A tertiary hospital, or tumor markers including PSA value; j) Patients who can tolerate with needle biopsy evaluated by physician in charge; and the biopsy is accepted by patients and their families; k) Follow-up =2 months; l) Patients who can provide true and effective information during the study and the follow-up; m) Patients or whose statutory guardian know the study process and content, with signed informed consent freely and voluntarily.

Exclusion criteria

Exclusion criteria: n) Patients with cognitive or psychological problems; o) ECOG score of 3-4 or blood biochemistry tests indicated to cease or delay chemotherapy; p) Patients who cannot provide sufficient tumor tissues or tumor cells for the study; q) Patients who are thought cannot finish the study or comply with the requirements of the study (for management or other reasons).

Design outcomes

Primary

MeasureTime frame
Objective remission rate;

Secondary

MeasureTime frame
Progression free survival;Overall survival;

Countries

China

Contacts

Public ContactShaosan Kang

North China University of Science and Technology Affiliated Hospital

kangshaosan@sina.com13623335683

Outcome results

None listed

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