Prostate Cancer (Post Prostatectomy)PPSARPNCT07516886
Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy
An observational study of Prostate Cancer (Post Prostatectomy) and Prostate Cancer (Adenocarcinoma), run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy), Prostate Cancer (Adenocarcinoma), Prostate Cancer (Diagnosis)
- What is being tested?
- Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteLithuania
- Study dates
- 22 Jan 2024to Jul 2039
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Urology
Kaunas, Kauno, LT-50161
Mindaugas Jievaltas, MD, PhD, Professor, +37037326090, urologijos.klinika@kaunoklinikos.lt
Gustas Sasnauskas, MD, PhD-Candidate
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer (Post Prostatectomy), Prostate Cancer (Adenocarcinoma), Prostate Cancer (Diagnosis), Prostate Specific Antigen, Radical Prostatectomy
- Being tested
- Radical Prostatectomy
- Keywords
- prostate cancer, persistent prostate-specific antigen, prostate-specific antigen, radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical ProstatectomyProcedure or surgery
Also called Robot-Assisted Radical Prostatectomy, Laparoscopic Radical Prostatectomy, Retropubic Radical Prostatectomy
Radical prostatectomy for the treatment of prostate cancer. Open retropubic, laparoscopic or robot-assisted.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of PSA Persistence on Metastasis-Free Survival (MFS)
Comparison of metastasis-free survival between patients with and without PSA persistence.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year after radical prostatectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start22 Jan 2024
- Primary completionJul 2039 (estimated)
- Study completionJul 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Post Prostatectomy)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustas Sasnauskas, Lithuanian University of Health Sciences
- Investigators
- Daimantas Milonas, MD, PhD, Professor, Principal investigator, Lietuvos sveikatos mokslų universitetas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516886
- Sponsor's protocol ID
- PPSARP-1
- Acronym
- PPSARP
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07516886
- Acronym / sponsor ID
- PPSARP / PPSARP-1
- Conditions
- Prostate Cancer (Post Prostatectomy), Prostate Cancer (Adenocarcinoma), Prostate Cancer (Diagnosis), Prostate Specific Antigen, Radical Prostatectomy
- Keywords
- prostate cancer, persistent prostate-specific antigen, prostate-specific antigen, radical prostatectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- Jul 2039 (estimated)
- Study completion
- Jul 2039 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-persistent PSA group | – | Procedure: Radical ProstatectomyPatients after radical prostatectomy with first postoperative prostate-specific antigen value of <0.1 ng/ml 4-8 weeks after radical prostatectomy. |
| Persistent PSA group | – | Procedure: Radical ProstatectomyPatients after radical prostatectomy with first postoperative prostate-specific antigen value of ≥0.1 ng/ml 4-8 weeks after radical prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical ProstatectomyAlso: Robot-Assisted Radical Prostatectomy, Laparoscopic Radical Prostatectomy, Retropubic Radical ProstatectomyRadical prostatectomy for the treatment of prostate cancer. Open retropubic, laparoscopic or robot-assisted. | Procedure or surgery | Non-persistent PSA group, Persistent PSA group |
Primary outcome
Impact of PSA Persistence on Metastasis-Free Survival (MFS)
Time frame: Up to 10 years after radical prostatectomy.
Comparison of metastasis-free survival between patients with and without PSA persistence.
Impact of PSA Persistence on Cancer-Specific Survival (CSS)
Time frame: Up to 10 years after radical prostatectomy.
Comparison of cancer-specific survival between patients with and without PSA persistence.
Impact of PSA Persistence on Overall Survival (OS)
Time frame: Up to 10 years after radical prostatectomy.
Comparison of overall survival between patients with and without PSA persistence.
Development of a Prognostic Nomogram Incorporating PSA Persistence
Time frame: Based on outcomes observed during up to 10 years of follow-up.
Development of a multivariable prognostic model incorporating early postoperative PSA status together with preoperative and postoperative clinicopathological variables to predict long-term oncological outcomes.
3 secondary outcomes
Impact of PSA Persistence on Biochemical Recurrence-Free Survival (BCRFS)
Time frame: Up to 10 years after radical prostatectomy.
Incidence of PSA Persistence
Time frame: Up to 10 years after radical prostatectomy.
Diagnostic Performance of PSMA PET-CT in Patients With Persistent PSA
Time frame: Up to 1 year after radical prostatectomy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daimantas Milonas, MD, PhD, Professor principal investigator
Lietuvos sveikatos mokslų universitetas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Post Prostatectomy) and Prostate Cancer (Adenocarcinoma), run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gustas Sasnauskas, MD (+37063605330, gustas.sas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of PSA Persistence on Metastasis-Free Survival (MFS) (time frame: Up to 10 years after radical prostatectomy.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.