Clinical utility of PSMA PET/CT for recurrent prostate cancer

JRCT ID: jRCTs051180037

Registered date:29/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: prostate cancer
• Date of first enrollment: 14/02/2019
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Intravenous administration of the radiopharmaceutical called [18F]-FSU880

Outcome(s)

Primary Outcome

Diagnostic performance of FSU880-PET/CT for recurrent prostate cancer
Clinical impact

• Secondary Outcome: Most optimal uptake period for scanning after injection

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Male

Include criteria

1. Patients (Age 20-85 y.o.) with prostate cancer
2. Patients who are suspected of having recurrence due to their increased PSA or diagnostic imaging after surgery for prostate cancer
3. Patients who are determined to be appropriate for this study by participating physicians according to the results of physical examination and blood/urine/physiological function tests.
4. Patients who give us written informed consent

Exclude criteria

1. Patients having a severe communication problem.
2. Patients with severe general condition.
3. Patients having severe renal dysfunction (eGFR<30 mL/min/1.73m3) expected to affect the distribution of [18F]FSU-880..
4. Patients to whom participating physicians judged to be inappropriate for this study.

Related Information

• Primary Sponsor: Nakamoto Yuji
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development