Prostate CancerNCT05188911
Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial
An observational study of Prostate Cancer and Castration-resistant Prostate Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Disease
- What is being tested?
- Abiraterone, Prednisone and Androgen deprivation therapy
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2020to 15 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic castration-resistant prostate cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Beihe Wang, +86(021)64175590, med_wangbh@163.com
Yao Zhu
About this study
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.
- Being tested
- Abiraterone, Prednisone, Androgen deprivation therapy
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbirateroneDrug
Patients would be treated with 1000mg abiraterone qd.
PrednisoneDrug
Patients would be treated with 5mg prednisone bid.
Androgen deprivation therapyDrug
Patients would get medical or surgical castration.
| Study group | Role | What they receive |
|---|---|---|
| mCRPC | Patients would be treated with 1000mg abiraterone qd. Patients would be treated with 5mg prednisone bid. Patients would get medical or surgical castration. Receives: Drug: Abiraterone; Drug: Prednisone; Drug: Androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion heterogeneity on dual-tracer PET/CT
Measured: 90 days
Genomic change
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start15 Jul 2020
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188911
- Sponsor's protocol ID
- ANGELA trial
- Status last verified
- Dec 2021
- First submitted
- 27 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39151419
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial
- ClinicalTrials.gov ID
- NCT05188911
- Acronym / sponsor ID
- ANGELA trial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mCRPC | – | Drug: Abiraterone, Drug: Prednisone, Drug: Androgen deprivation therapyPatients would be treated with 1000mg abiraterone qd. Patients would be treated with 5mg prednisone bid. Patients would get medical or surgical castration. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic castration-resistant prostate cancer
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbirateronePatients would be treated with 1000mg abiraterone qd. | Drug | mCRPC |
| PrednisonePatients would be treated with 5mg prednisone bid. | Drug | mCRPC |
| Androgen deprivation therapyPatients would get medical or surgical castration. | Drug | mCRPC |
Primary outcome
Lesion heterogeneity on dual-tracer PET/CT
Time frame: 90 days
Genomic change
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Derived from this study: PubMed 39151419Pan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Castration-resistant Prostate Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beihe Wang (+8602164175590, med_wangbh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion heterogeneity on dual-tracer PET/CT (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05188911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.