Prostate CancerNCT07682584
Predictors of BCR After RARP for Localized Prostate Cancer: A Retrospective Analysis
An observational study of Prostate Cancer and Biochemical Recurrence, run by First Affiliated Hospital of Fujian Medical University.
Trial summary
This retrospective study aims to identify predictive factors for biochemical recurrence (BCR) in patients with localized prostate cancer who underwent robot-assisted radical prostatectomy (RARP). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Biochemical Recurrence
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 30 Sep 2026
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with localized prostate adenocarcinoma (clinical stage T1-T2, N0M0) who underwent robot-assisted radical prostatectomy (RARP) at Fujian Medical University Affiliated First Hospital between January 2020 and May 2026. Consecutive patients meeting eligibility criteria are included. No specific sampling frame or probability sampling method is applied.
Who may be able to join
- Pathologically confirmed prostate adenocarcinoma
- Clinical stage localized prostate cancer (T1-T2, N0M0)
- Underwent robot-assisted radical prostatectomy (RARP)
- Age ≥ 18 years
- Complete clinical data including preoperative PSA, Gleason score, pathological T stage, and surgical margin status
- At least one postoperative PSA measurement available to determine biochemical recurrence status
- Signed informed consent for surgery and data use (or ethics committee waiver of consent for retrospective analysis)
Who cannot join
- Received neoadjuvant endocrine therapy, radiotherapy, or chemotherapy prior to surgery
- Concurrent active malignancy other than non-melanoma skin cancer
- Preoperative evidence of lymph node metastasis (N+), distant metastasis (M1), or clinical stage T3-T4
- Missing core predictors (e.g., preoperative PSA, Gleason score, pathological T stage) or insufficient postoperative PSA data to determine BCR status
- Received adjuvant radiotherapy or adjuvant endocrine therapy before biochemical recurrence was determined
- Severe cardiac, hepatic, or renal dysfunction, or life expectancy < 1 year
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predictors of Biochemical Recurrence After Robot-Assisted Radical Prostatectomy in Patients With Localized Prostate Cancer: A Retrospective Analysis
This retrospective study aims to identify predictive factors for biochemical recurrence (BCR) in patients with localized prostate cancer who underwent robot-assisted radical prostatectomy (RARP). BCR is defined as a rise in prostate-specific antigen (PSA) levels after surgery, which may indicate residual or recurrent disease.
We will analyze clinical, imaging, and pathological data from patients treated at Fujian Medical University Affiliated First Hospital between January 2024 and May 2026. Key variables include preoperative PSA, Gleason score, pathological T stage, surgical margin status, perineural invasion, prostate volume, MRI-based parameters (e.g., Pi-RADS score, SUVmax on PSMA PET/CT), and inflammatory markers.
Read more
Using logistic regression and machine learning approaches (random forest, XGBoost, SVM), we will develop and internally validate a predictive model to estimate individual BCR risk. The goal is to improve post-surgical risk stratification, guide personalized monitoring, and support clinical decision-making regarding adjuvant therapy.
This research has received ethical approval. Data will be anonymized and handled confidentially. Findings will be disseminated to inform clinical practice and future research.
- Conditions
- Prostate Cancer, Biochemical Recurrence
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RARP Cohort | Consecutive patients with localized prostate cancer who underwent robot-assisted radical prostatectomy (RARP) at Fujian Medical University Affiliated First Hospital between January 2024 and May 2026. Patients are followed postoperatively for biochemical recurrence (BCR). Clinical, imaging, and pathological data are collected to identify predictors of BCR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Recurrence
Biochemical recurrence (BCR) is defined as a postoperative serum prostate-specific antigen (PSA) level of ≥0.2 ng/mL on two consecutive measurements, with the second measurement confirming the elevation. This is the primary outcome event for the study, used to distinguish patients with recurrence from those without recurrence during follow-up.
Measured: From date of surgery until date of confirmed biochemical recurrence, assessed up to 76 months, from January 2020 to May 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682584
- Sponsor's protocol ID
- 20260505112216735
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single-center retrospective study, and patient data confidentiality agreements restrict sharing of individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Biochemical Recurrence After Robot-Assisted Radical Prostatectomy in Patients With Localized Prostate Cancer: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT07682584
- Acronym / sponsor ID
- 20260505112216735
- Conditions
- Prostate Cancer, Biochemical Recurrence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Jul 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 retrospective study aims to identify predictive factors for biochemical recurrence (BCR) in patients with localized prostate cancer who underwent robot-assisted radical prostatectomy (RARP). BCR is defined as a rise in prostate-specific antigen (PSA) levels after surgery, which may indicate residual or recurrent disease.
We will analyze clinical, imaging, and pathological data from patients treated at Fujian Medical University Affiliated First Hospital between January 2024 and May 2026. Key variables include preoperative PSA, Gleason score, pathological T stage, surgical margin status, perineural invasion, prostate volume, MRI-based parameters (e.g., Pi-RADS score, SUVmax on PSMA PET/CT), and inflammatory markers.
Using logistic regression and machine learning approaches (random forest, XGBoost, SVM), we will develop and internally validate a predictive model to estimate individual BCR risk. The goal is to improve post-surgical risk stratification, guide personalized monitoring, and support clinical decision-making regarding adjuvant therapy.
This research has received ethical approval. Data will be anonymized and handled confidentially. Findings will be disseminated to inform clinical practice and future research.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RARP Cohort | – | –Consecutive patients with localized prostate cancer who underwent robot-assisted radical prostatectomy (RARP) at Fujian Medical University Affiliated First Hospital between January 2024 and May 2026. Patients are followed postoperatively for biochemical recurrence (BCR). Clinical, imaging, and pathological data are collected to identify predictors of BCR. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with localized prostate adenocarcinoma (clinical stage T1-T2, N0M0) who underwent robot-assisted radical prostatectomy (RARP) at Fujian Medical University Affiliated First Hospital between January 2020 and May 2026. Consecutive patients meeting eligibility criteria are included. No specific sampling frame or probability sampling method is applied.
Key inclusion criteria (7 listed)
- Pathologically confirmed prostate adenocarcinoma
- Clinical stage localized prostate cancer (T1-T2, N0M0)
- Underwent robot-assisted radical prostatectomy (RARP)
- Age ≥ 18 years
- Complete clinical data including preoperative PSA, Gleason score, pathological T stage, and surgical margin status
Key exclusion criteria (6 listed)
- Received neoadjuvant endocrine therapy, radiotherapy, or chemotherapy prior to surgery
- Concurrent active malignancy other than non-melanoma skin cancer
- Preoperative evidence of lymph node metastasis (N+), distant metastasis (M1), or clinical stage T3-T4
- Missing core predictors (e.g., preoperative PSA, Gleason score, pathological T stage) or insufficient postoperative PSA data to determine BCR status
- Received adjuvant radiotherapy or adjuvant endocrine therapy before biochemical recurrence was determined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biochemical Recurrence
Time frame: From date of surgery until date of confirmed biochemical recurrence, assessed up to 76 months, from January 2020 to May 2026
Biochemical recurrence (BCR) is defined as a postoperative serum prostate-specific antigen (PSA) level of ≥0.2 ng/mL on two consecutive measurements, with the second measurement confirming the elevation. This is the primary outcome event for the study, used to distinguish patients with recurrence from those without recurrence during follow-up.
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 6 Jul 2026.
- Individual participant dataSharing planned: No. This is a single-center retrospective study, and patient data confidentiality agreements restrict sharing of individual participant data.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Biochemical Recurrence, run by First Affiliated Hospital of Fujian Medical University.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 ZhongHua Zhu (+8618060692924, drzhuzh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Recurrence (time frame: From date of surgery until date of confirmed biochemical recurrence, assessed up to 76 months, from January 2020 to May 2026). 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 6 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.