Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial

Prostate Cancer Clinical Trial

Official title:

Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188911
• Other study ID #: ANGELA trial
• Status: Recruiting
• Start date: July 15, 2020
• Est. completion date: July 15, 2022

Study information

• Verified date: December 2021
• Source: Fudan University
• Contact: Beihe Wang
• Phone: +8602164175590
• Email: med_wangbh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

By incorporating dual-tracer PET/CT (PSMA and FDG) and ctDNA, we aimed to evaluate lesion heterogeneity and genomic change of mCRPC patients receiving novel hormonal therapy. The relationship between treatment response and different molecular characterization, as well as imaging features would also be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Diagnosed as mCRPC according to EAU-ESTRO-SIOG 2016 and PSA > 10ng/ml;

2. No previous treatment with novel hormonal therapy;

3. ECOG 0-2;

4. Normal organ function, WBC >= 3000/mm3 or Neutrophil >= 1500/mm3;

5. Aged 18 to 85 years old when issuing written informed consent;

6. Life expectancy > 12 months.

7. Consent and able to carry out follow-up visit and cooperate with all other study procedures.

Exclusion Criteria:

1. Severe disease or other medical conditions suggesting a high risk of death within 1 year, which may interfere with follow-up. Decided by investigator;

2. Diagnosed with any other malignant tumor within 3 years before enrollment;

3. Unable to provide necessary follow-up information;

4. Other conditions that are judged as ineligible by the investigator.

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Metastatic Disease
• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Abiraterone
Patients would be treated with 1000mg abiraterone qd.
• Prednisone
Patients would be treated with 5mg prednisone bid.
• Androgen deprivation therapy
Patients would get medical or surgical castration.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion heterogeneity on dual-tracer PET/CT		90 days
Primary	Genomic change		30 days