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

• Sponsor: Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05188911
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Castration-resistant Prostate Cancer; Metastatic Disease	Drug: Abiraterone; Drug: Prednisone; Drug: Androgen deprivation therapy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial
• Actual Study Start Date: Jul 15, 2020
• Anticipated Primary Completion Date: Jul 15, 2022
• Anticipated Study Completion Date: Jul 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
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; Patients would be treated with 1000mg abiraterone qd.; Drug: Prednisone; Patients would be treated with 5mg prednisone bid.; Drug: Androgen deprivation therapy; Patients would get medical or surgical castration.

Outcome Measures

Primary Outcome Measures

1. Lesion heterogeneity on dual-tracer PET/CT [90 days]

2. Genomic change [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200000

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ding-Wei Ye, Dr., Fudan University
• ClinicalTrials.gov Identifier: NCT05188911
• Other Study ID Numbers: ANGELA trial
• First Posted: Jan 12, 2022
• Last Update Posted: Jan 12, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis; Prednisone; Androgens

Study Results

No Results Posted as of Jan 12, 2022