Clinical trial NCT06529549: Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Castration-resistant Prostate Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: mCRPC patients with bone metastases and progressed after first-line treatment of mCRPC stage

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prostate Specific Antigen (PSA) Response Rate
timeFrame: From enrollment to primary completion of study (up to approximately 3 years)
Secondary outcomes:
measure: Radiologic Progression-free Survival (rPFS)
timeFrame: 3 years
measure: Objective Response Rate (ORR)
timeFrame: From enrollment to primary completion of study (up to approximately 3 years)
measure: Duration of Response (DOR)
timeFrame: From enrollment to primary completion of study (up to approximately 3 years)
measure: Overall Survival (OS)
timeFrame: From enrollment to primary completion of study (up to approximately 3 years)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: