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The efficacy of PSMA PET/MR in the diagnosis and staging of prostate cancer

Clinical study on the validity and accuracy of PSMA PET/MR in the diagnosis and staging of prostate cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042373
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-01-25
Completion date
Unknown
Last updated
2021-04-26

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:Transretal prostatic biopsy
and&#32
PET/MR

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Men aged more than 18 years. 2. Men with a diagnosis of prostate adenocarcinoma confirmed by biopsy results. 3. Gleason score was 8-9 points. 4. Men with an expected survival exceeding 5 years. 5. ECOG 0-1 6. The participant is well-informed of the current treatment options and the design of this trial; he/she is willing and able to give informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: A patient may not enter the study if ANY of the following applies: 1. Bone metastasis or distant organ metastasis; 2. Prior exposure to any treatment for prostate cancer, including radiotherapy, chemotherapy, hormone therapy, focal therapy, etc.; 3. Prior transurethral enucleation or resection of the prostate; 4. Any abdominal surgery performed within 3 months prior to enrollment; 5. A transrectal prostate biopsy performed within 2 weeks prior to enrollment; 6. Sustained use of anticoagulation and antiplatelet drugs; 7. Any other previous or current malignancies; 8. Disease complicated by other severe systemic diseases which, in the judgment of the investigators, are likely to interfere with the treatment, assessment or compliance associated with this trial; 9. Participation in other trials which are ongoing or have been completed within 3 months; 10. Any contraindications for radiation therapy or surgery.

Design outcomes

Primary

MeasureTime frame
Imaging report information;

Secondary

MeasureTime frame
prostate specific antigen (PSA) level;rates of positive surgical margin;

Countries

China

Contacts

Public ContactShancheng Ren

Department of Urology, Shanghai Changhai Hospital

renshancheng@gmail.com+86 13917793885

Outcome results

None listed

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