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NCT Number: NCT06529549

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

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.

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer

Age range

18 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to provide informed consent.
  • Adult males from 18 to 75 years age.
  • History of histologically or cytologically confirmed adenocarcinoma
  • Documented evidence of metastatic castration resistant prostate cancer (mCRPC) and progressed after first-line treatment at mCRPC.
  • Evidence of target lesion in imaging studies.
  • ECOG performance status 0-1
  • Estimated survival≥12 weeks

Exclusion criteria

  • Do not meet the inclusion criteria.
  • Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.
  • Receiving organ transplantation in the last 3 months.
  • Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute).
  • Participants with pneumonia.
  • Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment
  • Unwilling and unable to provide informed consent.
  • Patients who are judged unsuitable for clinical trial participation by the investigators.

Treatment and study plan

Organoid-Based Drug Sensitivity Screening

Other

Residual tissue of bone metastatic sites from biopsies for genetic testing will be collected to culture organoid and perform drug sensitivity screening

Primary outcomes

  1. Prostate Specific Antigen (PSA) Response Rate

    Time frame: From enrollment to primary completion of study (up to approximately 3 years)

    Proportion of patients with a 50% decrease in PSA from baseline

Secondary outcomes

  1. Radiologic Progression-free Survival (rPFS)

    Time frame: 3 years

    Radiologic progression-free survival will be assessed from the time of the first dose to radiologic disease progression or death from any cause, whichever comes first.

  2. Objective Response Rate (ORR)

    Time frame: From enrollment to primary completion of study (up to approximately 3 years)

    Proportion of patients in complete remission (CR) plus partial remission (PR)

  3. Duration of Response (DOR)

    Time frame: From enrollment to primary completion of study (up to approximately 3 years)

    Time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause.

  4. Overall Survival (OS)

    Time frame: From enrollment to primary completion of study (up to approximately 3 years)

    Time between the start of treatment and death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Diwei Zhao

CONTACT

[email protected]

15989568094

Yonghong Li, MD

CONTACT

[email protected]

02087343656

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Prospective, Open-label, Single-arm Study on the Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients With Bone Metastasis Progressed After First-line Treatment

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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