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

Fudan University

Status: Unknown

Conditions: Metastatic Disease; Castration-resistant Prostate Cancer; Prostate Cancer

Treatments: Drug: Abiraterone; Drug: Androgen deprivation therapy; Drug: Prednisone

Study type: Observational

Funder types: Other

Identifiers

NCT05188911

ANGELA trial

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

mCRPC

Description:

Patients would be treated with 1000mg abiraterone qd. Patients would be treated with 5mg prednisone bid. Patients would get medical or surgical castration.

Treatment:

Drug: Abiraterone

Drug: Prednisone

Drug: Androgen deprivation therapy