Early postoperative PSA after prostate removal as a predictor of cancer outcomes
Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Lithuanian University of Health Sciences Academic / other |
| Locations | 1 site (Kaunas, Kauno) |
| Trial ID | NCT07516886 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous observational studies have linked early PSA persistence after prostatectomy to worse outcomes, but results vary and larger prospective data are limited.
Eligibility criteria
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 this trial is running
Kaunas, Kauno
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.