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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorLithuanian University of Health Sciences

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Radical Prostatectomy

    Procedure/Surgery

    Radical prostatectomy for the treatment of prostate cancer. Open retropubic, laparoscopic or robot-assisted.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Non-persistent PSA group1 intervention
Group B: Persistent PSA group1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.
4

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.

Secondary outcomes

1

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.
2

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.
3

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.

Other outcomes

Sponsors and contacts

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