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Clinical Study on Further Optimizing the Diagnostic Model of Prostate Cancer

Clinical Study of direct radical prostatectomy for highly doubtful localized prostate cancer diagnosed by fast mp-MRI combined with PSMA-PETCT

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038696
Enrollment
Unknown
Registered
2020-09-29
Start date
2020-10-15
Completion date
Unknown
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

Gold Standard:Pathological diagnosis of prostate cancer: Pathological findings from a biopsy of the prostate, or prostate cancer found after a transurethral resection of the prostate
serum&#32
(PSA)&#32
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Enolase&#32
(NSE)
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Multiparameter&#32
magnetic&#32
resonance&#32
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Sponsors

the Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: The clinical diagnosis of prostate cancer is suspected in all prostate disease patients who have abnormal serum PSA test, or abnormal DRE, or abnormal TRUS or MRI abnormal signal, which is consistent with the indication of the first prostate biopsy patients who meet the following criteria can be enrolled into the group: 1. Aged 18 to 80 years; 2. No significant cardiopulmonary dysfunction, no serious chronic diseases such as diabetes; ECOG Score 0-1; 3. Patients can be examined with diffusion-weighted imaging (DWI) and T2-weighted imaging (T2WI), and the PI-RADS score >=4; 4. Clinical staging of cT1-3bN0-1M0; 5. The patient does not want to receive a prostate biopsy; 6. The patient consented to a 68Ga-PSMA-PETCT examination and specific visualization of the prostate cancer site; 7. The PSMA-PETCT report was localized prostate cancer without distant lymph node, bone and visceral metastasis; 8. No neoadjuvant endocrine therapy or chemotherapy is required depending on the clinical stage, and is willing to undergo radical prostatectomy and standard lymphadenectomy; 9. The patient has no history of other organ malignancies; 10. The patient voluntarily signs an informed consent form.

Exclusion criteria

Exclusion criteria: Patients with prostate disease who did not meet the criteria for inclusion in the study, or who the researchers considered unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
mp-MRI;Ga68-PSMA-PETCT;

Countries

China

Contacts

Public ContactLiu Ranlu

Department of Urology, the Second Hospital of Tianjin Medical University

liuranlu1976@126.com+86 13612109268

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026