Clinical efficacy of pre-operative [F-18] Florastamin PSMA PET/CT in men with intermediate- or high-risk localized prostate cancer who undergo radical prostatectomy: Prospective single-arm clinical trial
- Conditions
- Neoplasms
- Registration Number
- KCT0009488
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 152
Male patients aged 19 to 80 years
Patients diagnosed with histopathologically confirmed prostate cancer
Intermediate or high-risk prostate cancer according to the D'Amico classification
Adequate functional status to carry out normal daily activities (Eastern Cooperative Oncology Group performance status of 0 or 1)
Patients capable of understanding and voluntarily consenting to the contents of the informed consent form
Patients suspected of pelvic distant metastases based on imaging or tissue examination
Patients with prior pelvic radiotherapy
Patients who have received hormone therapy, neoadjuvant chemotherapy, or radiotherapy for prostate cancer
Patients with reported allergies to substances used in previous PET/CT or MRI scans or research
Life expectancy of less than 5 years
Uncontrolled infectious diseases (persistent sepsis with fever despite treatment)
Mental disorders (schizophrenia, bipolar disorder, intellectual disability)
Patients with moderate to severe cardiovascular, cerebrovascular, respiratory, or hepatic diseases or other comorbidities that render them unsuitable for clinical trial participation
Patients diagnosed with another type of cancer within 2 years (excluding non-metastatic skin basal cell or cutaneous superficial squamous cell carcinoma (T1-3N0M0) or superficial bladder cancer)
Patients with pelvic metal implants affecting the quality of PET/CT images
Other patients deemed unsuitable for participation in the clinical trial according to investigator discretion
Claustrophobia
Patients who have undergone Ga-68 PSMA-11 PET-CT before treatment
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival rate (progression defined as biochemical recurrence, radiographic recurrence, castration-resistant prostate cancer progression, or death)
- Secondary Outcome Measures
Name Time Method To compare the progression-free survival rate and diagnostic and clinical evaluations post-prostate cancer treatment between the [F-18] Florastamin PSMA PET/CT group and a prospective cohort-matched control group (SUPER-PC-RP).