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

• Conditions: Prostate Cancer; Metastatic Disease; Castration-resistant Prostate Cancer
• Interventions: Drug: Abiraterone; Drug: Prednisone; Drug: Androgen deprivation therapy

• Registration Number: NCT05188911
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-15
• Status Verified: 2021-12
• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2021-12-27
• Last Update Submitted: 2021-12-27
• Study First Posted: 2022-01-12
• Last Update Posted: 2022-01-12
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mCRPC	Abiraterone	Patients would be treated with 1000mg abiraterone qd. Patients would be treated with 5mg prednisone bid. Patients would get medical or surgical castration.
mCRPC	Prednisone	Patients would be treated with 1000mg abiraterone qd. Patients would be treated with 5mg prednisone bid. Patients would get medical or surgical castration.
mCRPC	Androgen deprivation therapy	Patients would be treated with 1000mg abiraterone qd. Patients would be treated with 5mg prednisone bid. Patients would get medical or surgical castration.

Primary Outcome Measures

Name	Time	Method
Lesion heterogeneity on dual-tracer PET/CT	90 days
Genomic change	30 days

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China