Prostate CancerNCT04251546
Prediction Model fo Screening and Diagnosis of Prostate Cancer in PSA Gray Zone Based on Serum PHI Combined With TPV
An observational study of Prostate Cancer and PSA, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Prostate cancer (PCa) is a high incidence tumor of elderly men. In recent years, its incidence has rapidly increased in China. Serological examination of prostate-specific antigen (PSA) is particularly important in the early diagnosis of PCa, but its specificity is lower in gray areas with PSA between 4-10 ng / ml. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer, PSA
- What is being tested?
- p2PSA, Ultrasonic parameters and Transperineal prostate biopsy
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2020to 30 Sep 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This study selected patients with suspected prostate cancer in the Department of Urology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine from May 2019 to May 2022, and had a PSA test value of 4-10 ng / mL.
Who may be able to join
- Patient> 45 years of age
- Abnormal serum PSA
- Prostate nodules found by DRE
- Abnormal MRI or TRUS finding
Who cannot join
- Incomplete medical history
- Poor quality of serum samples
- Bacterial acute prostatitis diagnosed within 3 months before biopsy 4.5α reductase inhibitors, anabolic steroids, or antiandrogen drugs taken within 12 months before biopsy
- 5.Previous prostate biopsy history.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Guangyu Chen, MD., +86-1356414407, chenguangyu@xinhuamed.com.cn
About this study
Prostate cancer (PCa) is a high incidence tumor of elderly men. In recent years, its incidence has rapidly increased in China. Serological examination of prostate-specific antigen (PSA) is particularly important in the early diagnosis of PCa, but its specificity is lower in gray areas with PSA between 4-10 ng / ml. Proposition of prostate health index (PHI) strengthens the specificity of PSA gray area prostate cancer diagnosis, but the composition of the index only relies on serological examination, neglects imaging indicators, and cannot be comprehensively evaluated. Based on the preliminary basis of PHI research in the undergraduate department, combined with ultrasound imaging indicators of total prostate volume (TPV), this research group prospectively analyzed the efficacy of PHI combined with TPV to predict prostate cancer in patients with PSA gray areas, and established an improved version of PHI-TPV combination. The prediction model mPHI assesses the sensitivity of the new model to predict the risk of prostate cancer in the Chinese population, provides data support for puncture decisions of middle-aged and elderly male patients in the gray area of PSA in China, and provides reference and guidance for the individualized prevention and treatment of prostate cancer.
- Conditions
- Prostate Cancer, PSA
- Being tested
- p2PSA, Ultrasonic parameters, Transperineal prostate biopsy
- Keywords
- Prostate Cancer, PSA, PHI, ultrasound, TPV
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
p2PSADiagnostic test
p2PSA test(for calculation of PHI)
Ultrasonic parametersDiagnostic test
Ultrasonic parameters(TPV)
Transperineal prostate biopsyDiagnostic test
Transperineal prostate biopsy for confirmation of prostate cancer or benign disease
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Patients with suspected prostate cancer with a PSA test value of 4-10 ng / mL Receives: Diagnostic Test: p2PSA; Diagnostic Test: Ultrasonic parameters; Diagnostic Test: Transperineal prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases
Pathological confirmed diagnosis by transrectal ultrasound guided prostate biopsy (12 needles) according to a standardized protocol. If a suspicious low-density nodule is found during the ultrasound, biopsy to the nodule can be added. Place the prostate biopsy specimen in a 10% Formalin's specimen bag. The specimens were processed and evaluated by the Pathology Department of Xinhua Hospital.
Measured: 2019/05/01-2021/05/30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start4 Jan 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 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 Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251546
- Sponsor's protocol ID
- XH-20-002
- Status last verified
- May 2022
- First submitted
- 30 Jan 2020
- Last updated
- 6 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen H, Qian Y, Wu Y, Shi B, Zhou J, Qu F, Gu Z, Ding J, Yu Y. Modified Prostate Health Index Density Significantly Improves Clinically Significant Prostate Cancer (csPCa) Detection. Front Oncol. 2022 Apr 7;12:864111. doi: 10.3389/fonc.2022.864111. eCollection 2022.
PubMed 35463344
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model fo Screening and Diagnosis of Prostate Cancer in PSA Gray Zone Based on Serum PHI Combined With TPV
- ClinicalTrials.gov ID
- NCT04251546
- Acronym / sponsor ID
- XH-20-002
- Conditions
- Prostate Cancer, PSA
- Keywords
- Prostate Cancer, PSA, PHI, ultrasound, TPV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 5 Feb 2020 (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.
Prostate cancer (PCa) is a high incidence tumor of elderly men. In recent years, its incidence has rapidly increased in China. Serological examination of prostate-specific antigen (PSA) is particularly important in the early diagnosis of PCa, but its specificity is lower in gray areas with PSA between 4-10 ng / ml. Proposition of prostate health index (PHI) strengthens the specificity of PSA gray area prostate cancer diagnosis, but the composition of the index only relies on serological examination, neglects imaging indicators, and cannot be comprehensively evaluated. Based on the preliminary basis of PHI research in the undergraduate department, combined with ultrasound imaging indicators of total prostate volume (TPV), this research group prospectively analyzed the efficacy of PHI combined with TPV to predict prostate cancer in patients with PSA gray areas, and established an improved version of PHI-TPV combination. The prediction model mPHI assesses the sensitivity of the new model to predict the risk of prostate cancer in the Chinese population, provides data support for puncture decisions of middle-aged and elderly male patients in the gray area of PSA in China, and provides reference and guidance for the individualized prevention and treatment of prostate cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Diagnostic Test: p2PSA, Diagnostic Test: Ultrasonic parameters, Diagnostic Test: Transperineal prostate biopsyPatients with suspected prostate cancer with a PSA test value of 4-10 ng / mL |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study selected patients with suspected prostate cancer in the Department of Urology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine from May 2019 to May 2022, and had a PSA test value of 4-10 ng / mL.
Key inclusion criteria (4 listed)
- Patient> 45 years of age
- Abnormal serum PSA
- Prostate nodules found by DRE
- Abnormal MRI or TRUS finding
Key exclusion criteria (4 listed)
- Incomplete medical history
- Poor quality of serum samples
- Bacterial acute prostatitis diagnosed within 3 months before biopsy 4.5α reductase inhibitors, anabolic steroids, or antiandrogen drugs taken within 12 months before biopsy
- 5.Previous prostate biopsy history.
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 |
|---|---|---|
| p2PSAp2PSA test(for calculation of PHI) | Diagnostic test | Observational group |
| Ultrasonic parametersUltrasonic parameters(TPV) | Diagnostic test | Observational group |
| Transperineal prostate biopsyTransperineal prostate biopsy for confirmation of prostate cancer or benign disease | Diagnostic test | Observational group |
Primary outcome
Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases
Time frame: 2019/05/01-2021/05/30
Pathological confirmed diagnosis by transrectal ultrasound guided prostate biopsy (12 needles) according to a standardized protocol. If a suspicious low-density nodule is found during the ultrasound, biopsy to the nodule can be added. Place the prostate biopsy specimen in a 10% Formalin's specimen bag. The specimens were processed and evaluated by the Pathology Department of Xinhua Hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Derived from this study: PubMed 35463344Chen H, Qian Y, Wu Y, Shi B, Zhou J, Qu F, Gu Z, Ding J, Yu Y. Modified Prostate Health Index Density Significantly Improves Clinically Significant Prostate Cancer (csPCa) Detection. Front Oncol. 2022 Apr 7;12:864111. doi: 10.3389/fonc.2022.864111. eCollection 2022.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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 PSA, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 4 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 6 May 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 Yongjiang Yu, MD. (86-13916241036, yuyongjiang@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases (time frame: 2019/05/01-2021/05/30). 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 NCT04251546, 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 6 May 2022.