Actively Recruiting
Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy
Led by Lithuanian University of Health Sciences · Updated on 2026-04-08
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the prognostic value of early postoperative prostate-specific antigen (PSA) levels in men undergoing radical prostatectomy for prostate cancer. This prospective observational study aims to understand how early PSA levels after surgery relate to long-term cancer outcomes, including recurrence, metastasis, and survival. The study does not involve any investigational drugs or treatments, and patient care follows standard clinical guidelines without influence from study participation. Participants will undergo radical prostatectomy performed by open, laparoscopic, or robot-assisted methods. PSA measurements begin 4 to 8 weeks after surgery, preferably at 1 month. If early PSA is 0.1 ng/mL or higher, additional PSA tests will be done at 4 and 8 weeks later, with further imaging by PSMA PET/CT if PSA rises above 0.2 ng/mL within the first year. For those with lower PSA, regular monitoring occurs at specific intervals up to annual checks beyond 3 years. The study groups include patients with persistent PSA (≥0.1 ng/mL) and those without. Participants will be followed for up to 10 years with data collected from routine clinical visits and medical records. Researchers will assess outcomes such as metastasis-free survival, cancer-specific survival, overall survival, and biochemical recurrence-free survival. The study will also develop a prognostic model incorporating PSA persistence and evaluate the diagnostic accuracy of PSMA PET/CT imaging in patients with persistent PSA. No experimental interventions are applied, and monitoring aligns with standard care.
CONDITIONS
Brief Title
Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is an adult biological male.
- Patient has morphologically confirmed and untreated prostate cancer.
- Patient 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.
You will not qualify if you...
- Patient has radiologically or 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.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - During inpatient stay for the operation
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during hospital stay
Duration - Day of surgery and immediate recovery period
Participants undergo radical prostatectomy as part of their standard clinical care.
Hospital stay for surgery and immediate postoperative care
Duration - Up to 10 years after surgery
Participants have PSA measurements to monitor prostate-specific antigen levels after surgery according to routine clinical practice and disease progression.
Multiple PSA measurement visits: first at 4 to 8 weeks post-surgery, then additional visits depending on PSA levels and clinical recommendations
Trial Site Locations
Total: 1 location
1
Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Urology
Kaunas, Kauno, Lithuania, LT-50161
Actively Recruiting
Research Team
G
Gustas Sasnauskas, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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