Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy (PPSARP)

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer (Adenocarcinoma); Radical Prostatectomy; Prostate Cancer (Diagnosis); Prostate Specific Antigen; Prostate Cancer (Post Prostatectomy)
• Intervention / Treatment: Procedure: Radical Prostatectomy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Gustas Sasnauskas, MD; Phone Number: +37063605330; Email: gustas.sas@gmail.com

Study Locations

• Lithuania
  • Kauno
    • Kaunas, Kauno, Lithuania, LT-50161
      • Recruiting
      • Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Urology
      • Contact: Mindaugas Jievaltas, MD, PhD, Professor; Phone Number: +37037326090; Email: urologijos.klinika@kaunoklinikos.lt
      • Principal Investigator: Gustas Sasnauskas, MD, PhD-Candidate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-persistent PSA group; 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.; Other Names: Robot-Assisted Radical Prostatectomy; Laparoscopic Radical Prostatectomy; Retropubic Radical Prostatectomy
Persistent PSA group; 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.; Other Names: Robot-Assisted Radical Prostatectomy; Laparoscopic Radical Prostatectomy; Retropubic Radical Prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of PSA Persistence on Metastasis-Free Survival (MFS)	Comparison of metastasis-free survival between patients with and without PSA persistence.	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.	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.	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.	Based on outcomes observed during up to 10 years of follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 1 year after radical prostatectomy.

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Investigators: Principal Investigator: Daimantas Milonas, MD, PhD, Professor, Lietuvos sveikatos mokslų universitetas

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): July 1, 2039
• Study Completion (Estimated): July 1, 2039

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: prostate cancer; radical prostatectomy; prostate-specific antigen; persistent prostate-specific antigen
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Disease; Adenocarcinoma
• Other Study ID Numbers: PPSARP-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No