Prostate Cancer Metastatic DiseaseNCT06915714
The Prognostic Value of PET/CT for Tumor Progression in Patients With Metastatic Hormone-sensitive Prostate Cancer
An observational study of Prostate Cancer Metastatic Disease and PET / CT, run by Sun Yat-sen University at 1 site in China.
Trial summary
Investigators retrospectively collected data from consecutive patients treated at the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China, from October 2020 to March 2024. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer Metastatic Disease, PET / CT
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2024to 28 Feb 2025
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the enrolled patients were Asian(we are a affiliated hospital of a university based in Mainland china ).
Who may be able to join
- patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by PSA levels, radiographic tests and pathological information
- patients who underwent FDG and PSMA PET/CT prior to the initiation of medical treatment
Who cannot join
- patients who received novel hormone therapy or a prostate biopsy prior to PET/CT
- patients with other malignancies
- patients received hormone therapy without novel hormone therapy
- patients received chemotherapy or radiotherapy prior to or during novel hormone therapy
- absence of follow-up data at our institution
Trial locations and contacts
1 site in 1 country.
China1 site
First affiliated hospital, Sun Yat-sen univeristy
Guangzhou, Guangdong, 510080
About this study
Official title: The Prognostic Value of Quantitative Parameters Derived From Dual Scanning of FDG and PSMA PET/CT for Tumor Progression in Patients With Metastatic Hormone-sensitive Prostate Cancer Receiving Novel Hormone Therapy
Investigators retrospectively collected data from consecutive patients treated at the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China, from October 2020 to March 2024. The inclusion criteria were as follows: (1) patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by PSA levels, radiographic tests and pathological information; (2) patients who underwent FDG and PSMA PET/CT prior to the initiation of medical treatment. The exclusion criteria were as follows: (1) patients who received novel hormone therapy or a prostate biopsy prior to PET/CT; (2) patients with other malignancies; (3) patients received hormone therapy without NHT; (4) patients received chemotherapy or radiotherapy prior to or during novel hormone therapy; (5) absence of follow-up data at the hospital.
- Conditions
- Prostate Cancer Metastatic Disease, PET / CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | PCa40%MTV-P = High, PCa40%MTV-G = Low | |
| Group2 | PCa40%MTV-P = Low, PCa40%MTV-G = High | |
| Group3 | PCa40%MTV-P = Low, PCa40%MTV-G = Low | |
| Group4 | PCa40%MTV-P = High, PCa40%MTV-G = High |
What is being measured
The primary outcome is the main question the study is designed to answer.
Castration-Resistant Prostate Cancer free survival (CRPC-FS)
Measured: From date of the initiation of novel hormone therapy until the date of first documented either PSA or radiography-confirmed progression or date of the last follow-up for any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start2 Jun 2024
- Primary completion20 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Metastatic DiseaseStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng fufu, Sun Yat-sen University
- Investigators
- Fangzheng Xiang, Principal investigator, First affiliated hospital, Sun Yat-sen univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915714
- Sponsor's protocol ID
- IIT-2025-117
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Quantitative Parameters Derived From Dual Scanning of FDG and PSMA PET/CT for Tumor Progression in Patients With Metastatic Hormone-sensitive Prostate Cancer Receiving Novel Hormone Therapy
- ClinicalTrials.gov ID
- NCT06915714
- Acronym / sponsor ID
- IIT-2025-117
- Conditions
- Prostate Cancer Metastatic Disease, PET / CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 2 Jun 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 8 Apr 2025 (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.
Investigators retrospectively collected data from consecutive patients treated at the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China, from October 2020 to March 2024. The inclusion criteria were as follows: (1) patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by PSA levels, radiographic tests and pathological information; (2) patients who underwent FDG and PSMA PET/CT prior to the initiation of medical treatment. The exclusion criteria were as follows: (1) patients who received novel hormone therapy or a prostate biopsy prior to PET/CT; (2) patients with other malignancies; (3) patients received hormone therapy without NHT; (4) patients received chemotherapy or radiotherapy prior to or during novel hormone therapy; (5) absence of follow-up data at the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | –PCa40%MTV-P = High, PCa40%MTV-G = Low |
| Group2 | – | –PCa40%MTV-P = Low, PCa40%MTV-G = High |
| Group3 | – | –PCa40%MTV-P = Low, PCa40%MTV-G = Low |
| Group4 | – | –PCa40%MTV-P = High, PCa40%MTV-G = High |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the enrolled patients were Asian(we are a affiliated hospital of a university based in Mainland china ).
Key inclusion criteria (2 listed)
- patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by PSA levels, radiographic tests and pathological information
- patients who underwent FDG and PSMA PET/CT prior to the initiation of medical treatment
Key exclusion criteria (5 listed)
- patients who received novel hormone therapy or a prostate biopsy prior to PET/CT
- patients with other malignancies
- patients received hormone therapy without novel hormone therapy
- patients received chemotherapy or radiotherapy prior to or during novel hormone therapy
- absence of follow-up data at our institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Castration-Resistant Prostate Cancer free survival (CRPC-FS)
Time frame: From date of the initiation of novel hormone therapy until the date of first documented either PSA or radiography-confirmed progression or date of the last follow-up for any cause, whichever came first, assessed up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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.
Fangzheng Xiang principal investigator
First affiliated hospital, Sun Yat-sen univeristy
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 Metastatic Disease and PET / CT, run by Sun Yat-sen 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 8 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Castration-Resistant Prostate Cancer free survival (CRPC-FS) (time frame: From date of the initiation of novel hormone therapy until the date of first documented either PSA or radiography-confirmed progression or date of the last follow-up for any cause, whichever came first, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2025.