Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment

Last updated: July 26, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urologic Cancer

Prostate Cancer

Allergy

Treatment

Organoid-Based Drug Sensitivity Screening

Clinical Study ID

NCT06529549
2024-FXY-231
  • Ages 18-75
  • Male

Study Summary

This observational study aims to learn about the effects and safety of organoid-based drug sensitivity screening in mCRPC patients with bone metastases that progressed after first-line treatment. The main question it seeks to answer is:

Do doctors choose treatment agents based on organoid-based drug sensitivity screening results for mCRPC patients, resulting in a better response?

Participants already took bone metastasis biopsies for genetic testing based on current clinical guidelines. This study only takes residual tissue from biopsies for organoid culture.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Willing and able to provide informed consent.

  2. Adult males from 18 to 75 years age.

  3. History of histologically or cytologically confirmed adenocarcinoma

  4. Documented evidence of metastatic castration resistant prostate cancer (mCRPC) andprogressed after first-line treatment at mCRPC.

  5. Evidence of target lesion in imaging studies.

  6. ECOG performance status 0-1

  7. Estimated survival≥12 weeks

Exclusion

Exclusion Criteria:

  1. Do not meet the inclusion criteria.

  2. Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.

  3. Receiving organ transplantation in the last 3 months.

  4. Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute).

  5. Participants with pneumonia.

  6. Severe concurrent illness or co-morbid disease that would make the subjectunsuitable for enrolment

  7. Unwilling and unable to provide informed consent.

  8. Patients who are judged unsuitable for clinical trial participation by theinvestigators.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Organoid-Based Drug Sensitivity Screening
Phase:
Study Start date:
July 24, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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