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

NCT07516886 | Recruiting

• 1 other identifier: PPSARP-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer (Diagnosis); Prostate Specific Antigen; Prostate Cancer (Post Prostatectomy); Prostate Cancer (Adenocarcinoma); Radical Prostatectomy

Keywords

prostate cancer; persistent prostate-specific antigen; prostate-specific antigen; radical prostatectomy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Impact of PSA Persistence on Biochemical Recurrence-Free Survival (BCRFS)

  Up to 10 years after radical prostatectomy.

• Incidence of PSA Persistence

  Up to 10 years after radical prostatectomy.

• Diagnostic Performance of PSMA PET-CT in Patients With Persistent PSA

  Up to 1 year after radical prostatectomy.

Study Arms (2)

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

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

Interventions

Radical Prostatectomy PROCEDURE

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

Non-persistent PSA group; Persistent PSA group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Urology

Kaunas, Kauno, LT-50161, Lithuania

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue of prostate gland, seminal vesicles and lymph nodes.

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daimantas Milonas, MD, PhD, Professor

  Lietuvos sveikatos mokslų universitetas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustas Sasnauskas, MD

CONTACT

+37063605330; gustas.sas@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Candidate

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: January 22, 2024
• Primary Completion (Estimated): July 1, 2039
• Study Completion (Estimated): July 1, 2039
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

LI (1)