Analysis of Next Generation PET and Liquid Biopsy to Moni... | NCT05188911

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

NCT05188911

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Jan 12, 2022Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Prostate Cancer
Castration-resistant Prostate Cancer
Metastatic Disease

Interventions

Abiraterone
Prednisone
Androgen deprivation therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2020Actual

Primary Completion Date

Jul 15, 2022Estimated

Completion Date

Jul 15, 2022Estimated

First Submitted Date

Dec 27, 2021

First Submission Date that Met QC Criteria

Dec 27, 2021

First Posted Date

Jan 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2021

Last Update Posted Date

Jan 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Abiraterone	Drug	Patients would be treated with 1000mg abiraterone qd.	mCRPC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lesion heterogeneity on dual-tracer PET/CT		90 days
Genomic change		30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Metastatic castration-resistant prostate cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Beihe Wang	Contact	+8602164175590		med_wangbh@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center	Recruiting	Shanghai	Shanghai Municipality	200000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39151419	Derived	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.

ID	Term
D011471	Prostatic Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
C089740	abiraterone
D011241	Prednisone
D000726	Androgen Antagonists

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473