About this trial
This prospective observational study aims to evaluate the prognostic significance of early postoperative prostate-specific antigen (PSA) levels in patients undergoing radical prostatectomy for prostate cancer.
No investigational interventions will be performed. All diagnostic procedures, follow-up assessments, and treatments will be conducted in accordance with standard clinical practice and established prostate cancer management guidelines. Participation in the study will not influence treatment decisions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is an adult biological male.
Patient has morphologically confirmed and untreated prostate cancer.
Patient who will be treated with open, laparoscopic or robot-assisted laparoscopic radical prostatectomy.
Patient is informed about this observational study and has signed the informed consent form.
Disqualifiers
Patient has radiologically of morphologically confirmed prostate cancer metastases before the operation.
Patient received neoadjuvant prostate cancer treatment.
Patient is set to receive adjuvant treatment.
Patient has any contraindications for the operation.
Trial population
Study participants are patients undergoing radical surgical treatment for histologically confirmed prostate cancer in Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Urology.
Trial design
Case-control
Prospective
Treatments tested in this trial
Radical Prostatectomy
Procedure/SurgeryRadical prostatectomy for the treatment of prostate cancer. Open retropubic, laparoscopic or robot-assisted.
Treatment groups
Trial outcomes
Primary outcomes
Impact of PSA Persistence on Metastasis-Free Survival (MFS)
Comparison of metastasis-free survival between patients with and without PSA persistence.
Impact of PSA Persistence on Cancer-Specific Survival (CSS)
Comparison of cancer-specific survival between patients with and without PSA persistence.
Impact of PSA Persistence on Overall Survival (OS)
Comparison of overall survival between patients with and without PSA persistence.
Development of a Prognostic Nomogram Incorporating PSA Persistence
Development of a multivariable prognostic model incorporating early postoperative PSA status together with preoperative and postoperative clinicopathological variables to predict long-term oncological outcomes.
Secondary outcomes
Impact of PSA Persistence on Biochemical Recurrence-Free Survival (BCRFS)
Comparison of biochemical recurrence-free survival between patients with and without PSA persistence. Biochemical recurrence will be defined as two consecutive PSA values ≥0.2 ng/mL.
Incidence of PSA Persistence
Proportion of patients with PSA ≥0.1 ng/mL at 4-8 weeks after radical prostatectomy.
Diagnostic Performance of PSMA PET-CT in Patients With Persistent PSA
Sensitivity of PSMA PET-CT for detection of residual disease or metastases in patients with persistent PSA. Assessing the accuracy of PSMA PET-CT for different persistent PSA values.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.