Combining PSMA-PET/MR and p2PSA for early prostate cancer diagnosis

The Combination of PSMA-PET/MRI and p2PSA in Early Diagnosis of Prostate Cancer

This study is testing if using a combination of special imaging and blood tests can help doctors find prostate cancer earlier in patients who might have it.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Male
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05822726 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of combining PSMA-PET/MR imaging with p2PSA blood tests for the early diagnosis of prostate cancer. It will compare the diagnostic accuracy of this combination against each method used alone and also against mpMRI combined with p2PSA. Patients suspected of having early prostate cancer will undergo imaging and blood tests, with prostate biopsy serving as the definitive diagnostic standard. The study is designed as a single-center, prospective, non-randomized controlled trial.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 to 85 with suspected early prostate cancer based on specific clinical criteria.

Not a fit: Patients with high-risk prostate cancer characteristics or those who have received prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier and more accurate diagnosis of prostate cancer, improving patient outcomes.

How similar studies have performed: While the combination of imaging and blood tests is a common approach, this specific combination of PSMA-PET/MR and p2PSA is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Preoperative clinical judgment of suspected early prostate cancer (according to NCCN guidelines): meet PSA ≤ 20ng/ml and clinical stage\<T3, while meeting one of the following criteria:

   ① Digital rectal examination revealed suspicious nodules of the prostate;

   ② Transrectal prostate ultrasound or MRI found suspicious lesions;

   ③ PSA\>10 ng/ml；

   ④ PSA 4\~10ng/ml, f/t PSA suspicious or PSAD value suspicious;
2. Aged between 18 and 85 years;
3. Generally in good health, able to tolerate and cooperate with research interventions, such as prostate biopsy and radical prostatectomy Etc;
4. Provide a signed and dated informed consent form;
5. Commit to complying with research procedures and cooperate in the implementation of the entire process of research.

Exclusion Criteria:

1. Preoperative clinical characteristics of suspected high-risk prostate cancer (according to NCCN guidelines): meet PSA\>20 ng/ml or clinical stage ≥ T3;
2. Have received any treatment (endocrine therapy, radiotherapy, chemotherapy, prostate resection, etc.)
3. Have had prostatitis (infectious or non infectious) 3 months before the examination
4. Taking 5a reductase inhibitors
5. Previously diagnosed with prostate cancer
6. In the acute infection period and fever period;
7. Have a hypertensive crisis;
8. In the period of decompensation due to cardiac insufficiency;
9. Diseases with a tendency to severe bleeding;
10. In diabetes, blood sugar is unstable;
11. Have severe internal and external hemorrhoids, perianal or rectal lesions;
12. Combined with other systemic malignant tumors;
13. Implantation of functional electronic devices and various stimulators such as cardiac pacemakers, cochlear implants, and cardiac stents in vivo, with implants made of ferromagnetic materials (such as iron, cobalt, nickel, etc.);
14. A perfusion device implanted in the body, such as insulin or other perfusion pumps;
15. Have a history of surgery within the past 3 months, especially organ transplantation, heart and kidney surgery;
16. People with claustrophobia.

Where this trial is running

Shanghai, Shanghai

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)

Conditions Prostate Cancer; PSMA; p2PSA