Early postoperative PSA after prostate removal as a predictor of cancer outcomes
Official title: Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy
Run by Lithuanian University of Health Sciences · NCT07516886 · Data updated 2026-11-12
We will test whether early PSA levels after prostate removal can help predict long-term cancer outcomes in men undergoing radical prostatectomy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 500 (estimated) |
| Sponsor | Lithuanian University of Health Sciences Academic / other |
| Locations | 1 site (Kaunas, Kauno) |
| Status | Recruiting |
| Started | January 22, 2024 |
| Main results expected | July 2039 |
| Study ends | July 2039 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT07516886 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult biological men with untreated, non-metastatic prostate adenocarcinoma who are scheduled for open, laparoscopic, or robot-assisted radical prostatectomy and can attend follow-up at the study center.
✕Probably not a fit
Men with known metastatic disease before surgery, those who received neoadjuvant therapy or are set to receive immediate adjuvant treatment, and patients treated outside the study center are unlikely to benefit from this observational evaluation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center observational study will follow men undergoing radical prostatectomy and measure PSA at about 4–8 weeks after surgery, with repeat measurements if early PSA is ≥0.1 ng/mL. No experimental treatments will be given and all care will follow standard clinical guidelines, so participation does not change treatment decisions. The study aims to enroll about 400–500 participants over a five-year recruitment period at a single tertiary hospital. Investigators will examine whether early postoperative PSA persistence (≥0.1 ng/mL) predicts later oncological outcomes such as biochemical recurrence.
Why it matters
Potential benefit: If successful, early PSA testing could identify men at higher risk of recurrence so they can receive closer monitoring or earlier intervention.
How similar studies have gone: Previous observational studies have linked early PSA persistence after prostatectomy to worse outcomes, but results vary and larger prospective data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Urology
Kaunas, Kauno, Lithuania Recruiting
Study contacts
- Principal investigator: Daimantas Milonas, MD, PhD, Professor — Lietuvos sveikatos mokslų universitetas
- Study coordinator: Gustas Sasnauskas, MD
- Email: gustas.sas@gmail.com
- Phone: +37063605330
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.