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

NCT05188911 | Unknown

• 1 other identifier: ANGELA trial
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Castration-resistant Prostate Cancer; Metastatic Disease

Outcome Measures

Primary Outcomes (2)

• Lesion heterogeneity on dual-tracer PET/CT

  90 days

• Genomic change

  30 days

Study Arms (1)

mCRPC

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

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

Interventions

Abiraterone DRUG

Patients would be treated with 1000mg abiraterone qd.

mCRPC

Prednisone DRUG

Patients would be treated with 5mg prednisone bid.

mCRPC

Androgen deprivation therapy DRUG

Patients would get medical or surgical castration.

mCRPC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Metastatic castration-resistant prostate cancer

You may qualify if:

• Diagnosed as mCRPC according to EAU-ESTRO-SIOG 2016 and PSA \> 10ng/ml;
• No previous treatment with novel hormonal therapy;
• ECOG 0-2;
• Normal organ function, WBC \>= 3000/mm3 or Neutrophil \>= 1500/mm3;
• Aged 18 to 85 years old when issuing written informed consent;
• Life expectancy \> 12 months.
• Consent and able to carry out follow-up visit and cooperate with all other study procedures.

You may not qualify if:

• Severe disease or other medical conditions suggesting a high risk of death within 1 year, which may interfere with follow-up. Decided by investigator;
• Diagnosed with any other malignant tumor within 3 years before enrollment;
• Unable to provide necessary follow-up information;
• Other conditions that are judged as ineligible by the investigator.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (1)

• Pan J, Wu J, Wang B, Zhu B, Liu X, Gan H, Wei Y, Jin S, Hu X, Wang Q, Song S, Liu C, Ye D, Zhu Y. Interlesional response heterogeneity is associated with the prognosis of abiraterone treatment in metastatic castration-resistant prostate cancer. Med. 2024 Dec 13;5(12):1475-1484.e3. doi: 10.1016/j.medj.2024.07.020. Epub 2024 Aug 15.

  PMID: 39151419 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

abiraterone; Prednisone; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Beihe Wang

CONTACT

+8602164175590; med_wangbh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: July 15, 2020
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: January 12, 2022

Record last verified: 2021-12

Locations

CN (1)