Prostate Cancer (Adenocarcinoma)NCT06883474
Osteosclerotic Changes on CT Predict Survival in Prostate Cancer
An observational study of Prostate Cancer (Adenocarcinoma) and Prostate Cancer Metastatic Disease, run by Sun Yat-sen University.
Trial summary
The study specifically investigated PC patients with bone metastasis and conducted a comprehensive analysis of the correlation between OCs and patient survival outcomes. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Prostate Cancer Metastatic Disease
- What is being tested?
- Osteosclerotic Changes on Computed Tomography
- How many people
- 211 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2010to 30 May 2023
- 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: Prostate cancer patients with bone metastasis
Who may be able to join
- 1）Histopathological confirmation of prostate adenocarcinoma
- 2）Radiologically verified bone metastasis, assessed through bone scintigraphy and CT imaging from the initiation of systemic therapy until disease progression.
Who cannot join
- 1）Lacking of complete clinical profiles.
About this study
Official title: Osteosclerotic Changes on Computed Tomography Predict Disease Progression and Poor Survival in Prostate Cancer
The study specifically investigated PC patients with bone metastasis and conducted a comprehensive analysis of the correlation between OCs and patient survival outcomes.
- Being tested
- Osteosclerotic Changes on Computed Tomography
- Keywords
- Bone metastasis, computed tomography, osteosclerotic change, prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteosclerotic Changes on Computed TomographyOther
Osteosclerotic Changes on Computed Tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic progression-free survival
Measured: From enrollment to the end of treatment at 5 years
Secondary outcomes (1)
overall survival
Measured: From enrollment to the end of treatment at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Jul 2010
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies 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
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meiting Chen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883474
- Sponsor's protocol ID
- SYSUCC-BONE
- Status last verified
- Oct 2024
- First submitted
- 13 Mar 2025
- Last updated
- 21 Mar 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteosclerotic Changes on Computed Tomography Predict Disease Progression and Poor Survival in Prostate Cancer
- ClinicalTrials.gov ID
- NCT06883474
- Acronym / sponsor ID
- SYSUCC-BONE
- Keywords
- Bone metastasis, computed tomography, osteosclerotic change, prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 19 Mar 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.
The study specifically investigated PC patients with bone metastasis and conducted a comprehensive analysis of the correlation between OCs and patient survival outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prostate cancer patients with bone metastasis
Key inclusion criteria (2 listed)
- 1）Histopathological confirmation of prostate adenocarcinoma
- 2）Radiologically verified bone metastasis, assessed through bone scintigraphy and CT imaging from the initiation of systemic therapy until disease progression.
Key exclusion criteria (1 listed)
- 1）Lacking of complete clinical profiles.
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 |
|---|---|---|
| Osteosclerotic Changes on Computed TomographyOsteosclerotic Changes on Computed Tomography | Other | – |
Primary outcome
Radiographic progression-free survival
Time frame: From enrollment to the end of treatment at 5 years
1 secondary outcome
overall survival
Time frame: From enrollment to the end of treatment at 5 years
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 21 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Adenocarcinoma) and Prostate Cancer Metastatic Disease, run by Sun Yat-sen University.
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 1 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Radiographic progression-free survival (time frame: From enrollment to the end of treatment at 5 years). 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 21 Mar 2025.