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

Recruiting

• Conditions: Metastatic Castration-resistant Prostate Cancer
• Interventions: Other: Organoid-Based Drug Sensitivity Screening

• Registration Number: NCT06529549
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-24
• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2027-07-23
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

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) and progressed 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 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 subject unsuitable for enrolment
7. Unwilling and unable to provide informed consent.
8. Patients who are judged unsuitable for clinical trial participation by the investigators.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Organoid-Based Drug Sensitivity Screening	Organoid-Based Drug Sensitivity Screening	Organoid culture and drug sensitivity screening

Primary Outcome Measures

Name	Time	Method
Prostate Specific Antigen (PSA) Response Rate	From enrollment to primary completion of study (up to approximately 3 years)	Proportion of patients with a 50% decrease in PSA from baseline

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR)	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.
Objective Response Rate (ORR)	From enrollment to primary completion of study (up to approximately 3 years)	Proportion of patients in complete remission (CR) plus partial remission (PR)
Overall Survival (OS)	From enrollment to primary completion of study (up to approximately 3 years)	Time between the start of treatment and death from any cause
Radiologic Progression-free Survival (rPFS)	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.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China