An observational study in Prostate Cancer (Post Prostatectomy), Prostate Cancer (Adenocarcinoma) and Prostate Cancer (Diagnosis), sponsored by Lithuanian University of Health Sciences. Recruiting at 1 site in Lithuania. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Lithuanian University of Health Sciences · Observational
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.
This is a prospective, single-center, observational, investigator-initiated study designed to evaluate the prognostic significance of early postoperative prostate-specific antigen (PSA) levels in predicting long-term oncological outcomes after radical prostatectomy (RP) for prostate cancer.
The study does not involve investigational medicinal products. No experimental interventions will be applied. Patient management will follow standard clinical practice and established national and international prostate cancer treatment guidelines. Participation in the study will not influence treatment decisions.
Approximately 100 radical prostatectomies are performed annually at the study center. It is anticipated that 400-500 participants will be enrolled over a 5-year recruitment period. No formal sample size calculation was performed due to the observational nature of the study.
All patients who fulfill the eligibility criteria will be offered to participate in the study during their inpatient stay for the operation.
First PSA measurement will be done at 4-8 weeks after surgery, preferably at 1 month.
PSA persistence, defined as a serum PSA level ≥0.1 ng/mL 4-8 weeks after RP, will be assessed as a potential predictor of adverse oncological outcomes.
If the first PSA value after RP is ≥0.1 ng/mL, the second measurement will be taken 4 weeks later. The third one will be taken 8 weeks later. If PSA value during the first year increases to >0.2 ng/mL, Prostate-Specific Membrane Antigen Positron Emission Tomography/Computed Tomography (PSMA PET/CT) will be organized. PSA measurements will be continued based on disease progression, further treatment, and treating physician's recommendations.
If the first PSA value after RP is \<0.1 ng/mL or the second PSA value decreases from ≥0.1 ng/mL to \<0.1 ng/mL, PSA measurements will be taken at 3, 6, 9, ir 12 months after surgery, twice a year during the second and third year after surgery, and yearly thereafter.
PSA measurement could be taken more often and at different intervals due to disease progression, treatment or if advised by the treating physician.
Participants will be followed for up to 10 years according to routine clinical practice. Follow-up visits will occur according to routine clinical practice. Data will be collected from medical records and routine clinical documentation and entered into an electronic database.
The study will evaluate the association between early postoperative PSA levels and biochemical recurrence, metastasis, metastasis-free survival, overall survival, and cancer-specific survival. A prognostic model incorporating persistent PSA and other prostate cancer characteristics will be made. Diagnostic accuracy of PSMA PET-CT on patients with persistent PSA will be evaluated.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 500 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Lithuanian University of Health Sciences is the lead sponsor of 102 studies on the registry; 31 are open to participants now.
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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.
Exclusion Criteria:
Patients after radical prostatectomy with first postoperative prostate-specific antigen value of \<0.1 ng/ml 4-8 weeks after radical prostatectomy.
Procedure: Radical Prostatectomy
Patients after radical prostatectomy with first postoperative prostate-specific antigen value of ≥0.1 ng/ml 4-8 weeks after radical prostatectomy.
Procedure: Radical Prostatectomy
Radical prostatectomy for the treatment of prostate cancer. Open retropubic, laparoscopic or robot-assisted.
Also known as: Robot-Assisted Radical Prostatectomy, Laparoscopic Radical Prostatectomy, Retropubic Radical Prostatectomy
Impact of PSA Persistence on Metastasis-Free Survival (MFS)
Comparison of metastasis-free survival between patients with and without PSA persistence.
Time frame: Up to 10 years after radical prostatectomy.
Impact of PSA Persistence on Cancer-Specific Survival (CSS)
Comparison of cancer-specific survival between patients with and without PSA persistence.
Time frame: Up to 10 years after radical prostatectomy.
Impact of PSA Persistence on Overall Survival (OS)
Comparison of overall survival between patients with and without PSA persistence.
Time frame: Up to 10 years after radical prostatectomy.
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.
Time frame: Based on outcomes observed during up to 10 years of follow-up.
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.
Time frame: Up to 10 years after radical prostatectomy.
Incidence of PSA Persistence
Proportion of patients with PSA ≥0.1 ng/mL at 4-8 weeks after radical prostatectomy.
Time frame: Up to 10 years 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.
Time frame: Up to 1 year after radical prostatectomy.
Plan to share: Undecided — IPD sharing is currently undecided. Decisions regarding data sharing will be made after study completion in accordance with institutional policies and applicable data protection regulations.
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Lithuanian University of Health Sciences